Drug Quality and the Heart of Darkness

09/15/2014 07:31 PM |

Can there be a floor and a ceiling for global drug safety and quality? Even as we move toward differential pricing, should we allow some countries to have lower standards than others “based on local situations?”

When Paul Orhii, Director-General of Nigeria’s National Agency for Food and Drug Administration and Control, complained to the Chinese government that China was the origin of many of the counterfeit medicines in Nigeria, he was bluntly told Beijing was not responsible for the quality of medicines in Nigeria

When it comes to the safety of pharmaceuticals and medical devices, can one man’s ceiling be another man’s floor?

And how does this fit into the debate over trade policy versus trade practice? Should medical products that are determined not to meet any given national standard be allowed to be exported to other countries? Should there be a “good enough for me, good enough for thee” standard for international trade in pharmaceuticals and medical devices?

According to Poor Quality Drugs and Global Trade: A Pilot Study (a new paper from the National Bureau of Economic Research), Indian pharmaceutical companies are selling lower quality drugs at higher prices in Africa while at home on the Subcontinent, they’re selling the same drugs, manufactured to a higher quality standard at lower prices.

According to the paper’s abstract:

Experts claim that some Indian drug manufacturers cut corners and make substandard drugs for markets with non-existent, under-developed or emerging regulatory oversight, notably Africa. This paper assesses the quality of 1470 antibiotic and tuberculosis drug samples that claim to be made in India and were sold in Africa, India, and five mid-income non-African countries. We find that 10.9% of those products fail a basic assessment of active pharmaceutical ingredients (API), and the majority of the failures are substandard (7%) as they contain some correct API but the amount of API is under-dosed. The distribution of these substandard products is not random: they are more likely to be found as unregistered products in Africa than in India or non-African countries. Since this finding is robust for manufacturer-drug fixed effects, one likely explanation is that Indian pharmaceutical firms and/or their export intermediaries do indeed differentiate drug quality according to the destination of consumption.

That’s the unfortunate distinction between trade policy and trade practice. Is this an issue for TRIPS? Should TRIPS Article 61 be amended to include punishments and penalties for those who export medicines and medical devices that do not meet a certain global standard?

While domestic standards are undeniably an issue of domestic sovereignty, shouldn’t there be transparency as to how any given nation defines safety and quality? “Market authorization” means one thing in the context of the MHRA, the FDA, the EMA, and Health Canada (to choose only a few “gold standard” examples), but how are we to judge the regulatory competencies of other national systems? Is that the responsibility of the WHO via a better-developed (and far more transparent) pre-qualification scheme? Or regional arbiters? Should there be “reference regulatory systems” as there are reference nations for pricing decisions? Should there be regulatory reciprocity?

All the more reason for “gold standard” nations to undertake a regulatory Marshall Plan to help build global systems for drug quality and safety.

The harmonization of global trade policy and practice is essential to the sinews of international medicines quality and safety.

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Getting serious about NBCDs

09/14/2014 11:10 AM |

Let’s talk about Non-Biologic Complex Drugs (NBCD). If you look at the FDA’s recent actions relative to raising the issue of quality and performance of generic products and working with outside partners to seriously investigate the problem, you’d think that NBCDs are an obvious top of mind agenda item for the agency to consider and act on via Guidance. But, as with many difficult regulatory questions, predictability comes at the expense of ambiguity – and regulators have a penchant for embracing ambiguity.

When it comes to NBCDs (as with so many other issues), predictability is power in pursuit of the public health.

As my friend and former FDA colleague Dr. Scott Gottlieb has pointed out, a year ago, the Food and Drug Administration quietly posted a public notice that it wanted to hire an independent lab to test a generic drug that it had already approved. FDA wanted to make sure the drug was safe and effective.

The issue concerned a copy formulation of a complex, intravenous medicine used to replenish kidney-dialysis patients’ stores of iron. FDA had approved this “generic” version of the drug in March 2011 because it believed that laboratory data showed that the replica version of the drug was the exact same as the original branded medicine it was copied from. In announcing the request for independent testing of the generic version, FDA was indirectly saying it might have been wrong.

FDA was going back to get more evidence – including data looking at how the drug was behaving in patients – to make sure that its original decision was sound. Additional evidence was needed because this type of drug represents a new chapter in FDA drug approvals. By law, generic drugs are supposed to contain identical copies of the active ingredient of the original branded medicine that they are copied from. With almost all generic drugs, making identical copies has been relatively easy because the original medicine was a small molecule, which has a simple molecular structure. In contrast, complex drugs involve large molecules and are difficult to copy. In fact, their physical and chemical properties may not be fully understood. Even so, FDA has begun to approve generic copies of complex drugs.

Now, on the anticipated eve of one of the most significant generic drug approval decisions in recent years—involving another complex drug—the lesson from the generic IV iron episode bears reminding. FDA is widely known to be considering the approval of a generic version of Teva Pharmaceutical’s blockbuster drug for multiple sclerosis, Copaxone. The patents covering Copaxone for its 20mg/ml strength expired on May 24th. After patent expiration, FDA could approve generic copies of the drug at any time. But some of the same challenges that caused the agency to struggle with and sometimes stumble over its similar previous decisions still linger, and will color FDA’s decision concerning Copaxone.

Gottlieb believes (and I concur), that when it comes to evaluating copies of these complex drugs, the fact is FDA doesn’t have very good tools and policies. These drugs slip between FDA’s other generic drug constructs. They are less complex than biological drugs, which have their own separate law governing how the agency should review and approve copy versions. (Unlike with the generic drug law, the approval of copy versions of biologicals generally must be supported by evidence from human studies.) But non-biological complex drugs are far trickier than generic versions of the normal, small molecule pill drugs that FDA is accustomed to evaluating. It’s that framework for these small molecule drugs that FDA has been trying to apply to these complex drugs.

These challenges illustrate a need to reconsider how FDA approves copy versions of complex drugs. Perhaps different approval standards should be used. Current law already contains an appropriate alternative to the generic drug law in the pathway used for the review and approval of copies of biological drugs, which gives FDA more latitude when it comes to the data it can use as a the basis for these approvals. Some of these principles could be applied to a new category that addresses the complex drugs. Or Congress could re-write certain aspects of the generic drug law, tailoring generic drug principles to the unique challenges of copying complex drugs.

As Gottlieb points out, FDA also needs to change its practices when it comes to these complex drugs, to more clearly establish reliable principles for how generic copies of these medicines can be safely brought to market once brand-name patents have expired. It needs to develop these scientific principles in a more transparent and inclusive process that leverages the expertise that FDA doesn’t readily posses to discern these laws of drug science.

The complex drugs fall in a regulatory gap. FDA has tried to retrofit the “Hatch Waxman” generic drug law and policies that govern approval of small molecule drugs to these complex drugs, with sometimes troubling results. Regardless of the decision FDA makes with Copaxone, it remains clear that Congress and FDA alike need to re-examine the regulatory process when it comes to these intricate drugs.

The problem is that FDA has refused to define these complex drugs as distinct from normal, small molecule medicines. That has forced the agency to rely on less information in approving these complex copies than it probably would like. The agency’s desire to try and squeeze these complex drugs through its existing generic law approval pathway may have as much to do with political expediency as with good science. FDA is probably well aware that getting Congress to define a distinct category for these medicines, and give FDA proper tools, could be a heavy political lift. So FDA is doing what it often does: trying to massage its existing authorities and regulatory practices to fit novel challenges.

The challenge isn’t just the generic drug law, which doesn’t allow FDA to look at much more than bioequivalence data. The setback is what FDA has done in response to these limitations, to try and retrofit its existing policies on complex drugs where the generic drug principles are sometimes poorly suited. And FDA has entered this new chapter in generic drug approvals largely under the radar. Congress and the public generally are not aware of the new direction FDA is taking.

Instead of acknowledging that it needs a broader scope of data to ensure “sameness” (the statutory standard for a generic drug approval) between the original and the copy drug, FDA has typically divined new science in these circumstances – coming up with novel principles of drug science to determine how two drugs can be declared the same by comparing laboratory data that FDA often establishes on its own novel principles. Such is the case with the gene expression data that FDA is examining in the case of Copaxone.

The foundational problem here is that the FDA is in the business of evaluating data against known standards, not establishing those standards de novo. The enterprise of establishing standards upon which two highly complex drugs can be judged the same requires a great deal of expertise in discrete areas of science. This sort of expertise doesn’t exist in one place, and certainly isn’t the province of FDA. That’s not a knock on FDA, or its scientists. This sort of work just isn’t the business that Congress has tasked the agency with doing. FDA is not staffed or resourced to take on the task of developing novel principles of biology and discovering the standards for measuring how drugs affect biological systems.

Per Gottlieb, As a result, FDA has often established principles that are at times embarrassingly incomplete, and sometimes spectacularly wrong. The re-adjudication of the generic IV iron approvals is one example. The problems FDA had in 2008 assuring safety and effectiveness of generic, copy versions of intravenous heparin is another example. FDA had to recently walk back guidance it put out on how to copy a popular eye drop that was another complex formulation. In each case FDA had established some principles upon which the agency thought it could reliably determine that two complex drugs were the same. In each case, FDA was wrong.

Not subtle – but 100% on target.

FDA needs to adopt a more transparent and inclusive process for developing the scientific principles upon which it makes judgments on NBCDs and draft guidance that generalizes these principles, preferably well in advance of patent expirations that create the opportunity for generic entry. By establishing them in an open process, FDA would make this important knowledge generally available, and would lower the barrier to market entry by generic firms of different levels of technical sophistication. It should be emphasized that FDA’s current lack of transparency makes it hard for many generic-drug companies to get on the playing field. Transparency, per Gottlieb, could promote generic competition.

Amen.

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Upton's Accelerated Pathway

09/13/2014 07:38 AM |

The fact-finding phase is over. At the September 10^th 21^st Century Cures Initiative roundtable, E&C Chairman Fred Upton (R/MI), said that committee staff will now begin developing draft legislation. “We intend to release a Cures legislative discussion draft in early January 2015 and will look to swiftly move the legislation early in the next Congress.”

But, per Ranking Committee Member Henry Waxman (D/CA), “If we come in with a blunt instrument, suddenly recreating the FDA authorities or mandating things for FDA or … the Department of Health and Human Services to do things they are not equipped to do – and that we of course don’t fund them to do – I think we have to be cautious about some the legislation that may be proposed.”

Waxman’s fear of unintended consequences may seem unusual for someone who often advocates for an active government role in addressing societal problems, but he noted that one of the major reforms at FDA in recent decades, the creation of accelerated approval, was spurred on by AIDS activists, and not by legislation. “The people that brought home the reform at FDA, that got some of these therapies out quickly, were the ACT UP group and the gay community,” he said. “They studied the law of FDA and argued, ‘You don’t need to take so long, you don’t have to weight to the end result to show that the therapy is safe and effective, you can have markers to get these products out more quickly.’”

Stand by for action. 

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ASCO Continues Work On Rationing Cancer Drugs

09/11/2014 02:42 PM |

Here's Lowell Schnipper who is in charge of ASCO's  cancer rationing app project on me-too drugs:  "The oncologist said one way to increase value in cancer medication is to avoid "me-too drugs" that provide marginal clinical gains over existing drugs. "Those are drugs that shouldn't be highly valued like a drug that provides four times the value," he told me. "From a societal perspective, we shouldn't give them a high price designation."

This is being dumb by design or default.  Either way it's dumb.

What is a me-too drug?  Does Schnipper regard all medicines that treat HER-2 positive tumors as alike?  What about the variations in epigenetics that a range of drugs control for?    Should an oral version of an older drug be considered me-too?  

And again Schnipper talks about 'marginal gains.'   He has previously said 3 months of life is marginal.   And he has yet to explain how spending on new medicines to extend life is more of a waste of money than, say, spending money on pre-natal care which has also produced  marginal results.   Or more broadly, why spending money on new medicines where there is no other treatment available somehow wrecks our economy.     Really?   When if we DOUBLED what we spent on cancer medicines it would be all of 1 percent of total health care spending?? 

Schnipper's obsession with ending life by force or fiat is what explains his drive and shapes his desire to ration drugs.   And so far, he and ASCO have avoided debating or discussing the cancer rationing app.  

That's playiing dumb.  By design.

For those of you interested in the other side  of this issue, here's my article on the ASCO cancer rationing app.

http://bit.ly/1seDNhl  Read More & Comment...

The Golden Rule of Healthcare

09/10/2014 07:36 AM |

From today’s edition of the Washington Examiner …

Cheaper drugs can also mean less choice without savings for patients

Peter J. Pitts

The economics of American healthcare are dictated by the Golden Rule: "He who has the gold makes the rules.” And those rules reward corporate greed at the expense of physician empowerment and patient care.

The gold in this case is the money leveraged by pharmacy benefit managers (PBMs) to reimburse patients for their medicines. And it’s a golden hammer used to negotiate lower prices from pharmaceutical companies. But where do those savings go, and what is the impact on a physician's ability to practice medicine and — most importantly, therapeutic outcomes for patients?

PBMs are large organizations responsible for not only processing and paying prescription drug claims, but developing and maintaining an insurance company’s formulary (the list of prescription drugs covered by a particular drug benefit plan), contracting with pharmacies, and negotiating discounts and rebates with drug manufacturers. Today, whether or not they know it, more than 210 million Americans nationwide receive drug benefits administered by PBMs.

But the savings garnered through bare-knuckle negotiations are not being passed down to patients. Lower drugs costs negotiated by payers are being used to fatten the corporate coffers of those same organizations. Consider the 2010 comment of George Paz, chairman and chief executive of Express Scripts (one of our nation’s largest PBMs), “The cheapest drugs is (sic) where we make our profits.” And just who is “cheaper” better for? "Our whole model is switching people to lower-cost drugs. The more money my shareholders make, the more money I make."

Paz ranked sixth on the 2012 Forbes CEO compensation list, with $51.5 million in total compensation the preceding year, and $100.2 million over a five-year period.

More money for George and Co., but less choice and no savings for patients. This has been the case with brand vs. generic medicines for years. But at least these often resulted in lower out-of-pocket co-pay expenses for patients. Today, the same fatten-George’s Wallet schemes are being used for drugs for evermore serious and life-threatening conditions. Consider Multiple Sclerosis, an autoimmune disease that affects the brain and spinal cord of over 400,000 Americans.

Express Scripts has decided to only reimburse for some MS treatments — and the differentiator isn’t paying for “better” ones. The ones they chose are generally newer medicines with the highest market share. Why? Consider the math. The higher the volume, the bigger the cudgel, the larger the cumulative discount.

But what about those patients whose disease is being well managed on older therapies with smaller market share? Sorry, no dice. Physicians are being told (told!) by Big Payer to monkey with successful therapies because they don't add enough to the bottom line. This is particularly galling in the case of MS, where the ability to successfully manage any given patient’s disease with any given medicine cannot be predicted. There is no way to determine ahead of time which drug works best for any given patient. And one drug (say an older treatment with a single-digit market share) is not necessarily interchangeable with a newer drug (which has double-digit penetration).

Another frightening fact is that upwards of 20 percent of MS patients, when forced to switch from successful treatments to payment-dictated ones simply stop taking their medicines or opt for “drug holidays” because of new and unpleasant side effects.

If patients are in an uproar, physicians are furious — and frightened. If a doctor is forced to change a patient’s therapy because of Big Payer pressure, what happens when something goes wrong and a malpractice suit gets filed? Is there any validity to “the payer made me do it” defense? Nobody wants to be the test case.

PBM’s will say they’re negotiating on behalf of the employer health plans they serve, that their tactics reduce employer costs. Not true. Higher co-pays for off-formulary medicines lead to dramatically higher rates of non-adherence. Data from one large employer with over 60,000 insured workers shows that in the first few months since the implementation of PBM drug exclusions, nearly 50 percent of “rejected” prescriptions remain unfilled. Non-adherence is the major cause of poor health outcomes. That’s a pyrrhic trade-off.

This is healthcare reform? Indeed it is, since the basic tenet of Obamacare is to reduce costs rather than expedite appropriate care. In fact, the drug formularies of most state exchanges are equally if not more draconian than those designed by Express Scripts. Unfortunately, no two patients have the same biochemistry and no two medicines are exactly equivalent. But if your primary goal is to minimize short-term costs so that you can maximize your quarterly profit (in the case of Express Scripts) or keep premiums low but co-pays high (the goal for state healthcare exchanges), that's an inconvenient truth.

The repercussions of choosing short-term thinking over long-term results, of cost-based choices over patient-based care, of “any-medicine-will do,” over the right medicine for the right patient at the right time are pernicious to both the public purse as well as the public health.

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Janet and her purple crayon

09/09/2014 03:18 PM |

Welcome to “the Purple Book” – FDA’s “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.”

On the nomenclature front, one immediate take-away is that the FDA makes clearly states:

“The lists cross-reference the names of biological products licensed under section 351(a) of the Public Health Service Act (PHS Act) with the names of biosimilar or interchangeable biological products licensed under section 351(k) of the PHS Act by the FDA (see below for an explanation of the sections 351(a) and 351(k) of the PHS Act).”

Per the FDA:

The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

Separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will be updated periodically.

For those of you following the debate on Non-Biologic Complex Drugs (NBCDs) – such as Copaxone – the fact that the agency is drawing a distinction between CBER and CDER is significant. It is distinction with a difference.

IMHO, products such as copaxone should demand "to be purple rather than orange." Clearly, copaxone has much more in common with biologics -- and since the agency is now making a distinction between large molecules approved by CDER and CBER -- it seems logical to "keep like things together." NBCDs aren't small molecules and don't belong in the Orange Book.

Purple, after all, is the color of good judgment.

Background Information: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

What are these lists?

These lists are designed to help enable a user to see whether a particular biological product has been determined by the Food and Drug Administration (FDA) to be biosimilar to or interchangeable with a reference biological product. The lists cross-reference the names of biological products licensed under section 351(a) of the Public Health Service Act (PHS Act) with the names of biosimilar or interchangeable biological products licensed under section 351(k) of the PHS Act by the FDA (see below for an explanation of the sections 351(a) and 351(k) of the PHS Act). There will be separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

For products licensed under section 351(a) of the PHS Act, the lists identify the date the biological product was licensed and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act (see below for an explanation of reference product exclusivity). If FDA has determined that a biological product is protected by a period of reference product exclusivity, the list will identify the date of first licensure and the date that reference product exclusivity (including any attached pediatric exclusivity) will expire. The list will not identify periods of orphan exclusivity and their expiration dates for biological products as those dates are available at the searchable database for Orphan Designated and/or Approved Products.

Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

What is a reference product, biosimilar, and interchangeable product?

Under section 351(i)(4), a “reference product” is the single biological product licensed by FDA under section 351(a) of the PHS Act against which a proposed biological product is evaluated in an application submitted under section 351(k).

Under section 351(i)(2), “biosimilar” or “biosimilarity” means that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency of the product.

Under 351(k)(4), an “interchangeable” biological product is a product that has been shown to be biosimilar to the reference product, and can be expected to produce the same clinical result as the reference product in any given patient. In addition, to be determined to be an interchangeable biological product, it must be shown that for a biological product that is administered more than once to an individual the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.

What is reference product exclusivity?

Section 351(k)(7) of the PHS Act describes reference product exclusivity as the period of time from the date of first licensure of a reference product, the single biological product licensed under section 351(a) of the PHS Act against which a biological product is evaluated in a 351(k) application, during which a 351(k) sponsor is not permitted to submit and FDA is not permitted to license a 351(k) application that references the reference product. Specifically, if the reference product has reference product exclusivity under this section, approval of a 351(k) application may not be made effective until the date that is 12 years after the date of first licensure of the reference product, and a 351(k) application may not be submitted for review to FDA until the date that is 4 years after the date of first licensure. See 351(k)(7). For additional information on how FDA determines the date of first licensure and reference product exclusivity, please see the draft guidance for industry, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (PDF - 99KB).”

What does the reference product exclusivity expiry date indicate?

The reference product exclusivity expiry date indicates (1) the date that is 12 years from the date of first licensure as described in 351(k)(7); plus (2) any pediatric exclusivity granted pursuant to section 505(A) of the FD&C Act, if applicable. The reference product exclusivity expiry date is the date on which a 351(k) application referencing the reference product may be licensed, assuming it is not blocked by orphan exclusivity and otherwise meets the requirements for licensure under 351(k). To determine whether there is unexpired orphan exclusivity for an indication for which the reference product is licensed, please refer to the searchable database for Orphan Designated and/or Approved Products.

For additional information on determining the date of first licensure for purposes of determining reference product exclusivity, please see the draft guidance for industry, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (PDF - 99KB).”

Why is a determination of the date of first licensure not made for every 351(a) biological product licensed and currently marketed?

Although FDA has not made a determination of the date of first licensure for all 351(a) biological products included on the lists, it does not mean that the biological products on the list are not, or were not, eligible for exclusivity. A determination of the date of first licensure and of when any remaining reference product exclusivity will expire for a biological product submitted under section 351(a) of the PHS Act will generally be made for reasons of regulatory necessity and/or at the request of the 351(a) application license holder.

How often will these lists be updated?

As resources permit, these lists will be updated periodically when FDA licenses a biological product under section 351(a) or section 351(k) of the PHS Act and/or makes a determination regarding date of first licensure for a biological product licensed under section 351(a) of the PHS Act.

What should a healthcare practitioner keep in mind while using these lists?

Professional care and judgment should be exercised in using these lists. Evaluations of biosimilarity and interchangeability for biological products are based on scientific and medical evaluations by FDA under section 351(k) of the PHS Act. FDA’s determination that a product is biosimilar to a reference product or interchangeable with a reference product means that FDA has determined that the biological product meets the requirements for such products (see definitions above).

Why Purple?

The “Purple Book” is an easy-to-remember nickname for the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” Using a color for the nickname of the list draws upon FDA’s long-held practice of using “The Orange Book” to refer to “Approved Drug Products with Therapeutic Equivalence Evaluations,” the Agency’s reference listing of all drugs approved under the Federal Food, Drug and Cosmetic Act. Over the years, health care professionals and other stakeholders have come to use the term “Orange Book” in place of this longer, official title. FDA wanted a similarly user-friendly term for a reference listing biologics, biosimilars, and interchangeable products. During a meeting, a staff member said, “how about purple?” Ever since, we’ve called it the “Purple Book.”

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Pain Point/Counterpoint

09/09/2014 08:54 AM |

In a Huffington Post article, Patrick Krill, director of the Legal Professionals Program in the Hazelden Betty Ford Foundation, in an Huffington Post voices support for the recent lawsuits by California and Chicago against the manufacturers of opioid painkillers, pointing out that the some pharmaceutical companies “used deliberately misleading marketing techniques to cause an explosion in prescriptions for, and sales of, some of the most addictive chemical compounds man has ever engineered.”

At the same time, per law360.com, numerous pharmaceutical companies asked an Illinois federal judge on Friday to throw out the city of Chicago's suit claiming that their allegedly irresponsible marketing of addictive opioid painkillers has caused a costly public health crisis, arguing that the claims are too generalized to move forward.

 In multiple motions to dismiss, Purdue, Janssen Pharmaceuticals Inc., Teva Pharmaceutical Industries Ltd., Endo Health Solutions Inc. and Actavis PLC make similar arguments asking U.S. District Judge Elaine E. Bucklo to toss the case. According to the drug companies, the complaint fails to adequately state a claim against individual defendants, some of which the companies say are barely mentioned in the complaint at all.

 “The city simply lumps all defendants together as a group, ignoring relevant differences between the drugs they are alleged to have manufactured, the U.S. Food & Drug Administration-approved indications and the warnings the drugs carried, and the dates the drugs were marketed, and providing no specifics about any defendant’s alleged role in the alleged scheme,” the drug companies’ motion states. “The complaint could serve as a textbook example of improper group pleading.”

In addition to arguing the case should be tossed because of a failure to state a claim, the drug companies urged Judge Bucklo to dismiss Chicago’s complaint based on the doctrine of primary jurisdiction, arguing the city’s claims raise complex issues uniquely suited for the FDA and that those issues are currently being considered by the agency.

“In asking this court to decide scientific and policy matters that fall squarely within the province of, and are currently being addressed by, the FDA, the city has jumped the gun by suing before the FDA has resolved those issues,” the defendants’ motion states. “As multiple courts have done, this court should dismiss or stay this action to allow the FDA to first address these matters within the framework it has defined and is currently implementing.”

 The case is City of Chicago v. Purdue Pharma LP, et al., case number 1:14-cv-04361, in the U.S. District Court for the Northern District of Illinois, Eastern Division.

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Access to Innovation: Obstacles and Opportunities

09/08/2014 06:48 AM |

Healthcare innovation saves lives, saves money, promotes economic growth, and provides hope for hundreds of millions of people (both patients and care-givers) in the United States and around the world. But innovation isn’t easy.

In 1950, Americans spent about 5 percent of their income on health care. Today the share is about 16 percent. According to Harvard University economist N. Gregory Mankiw, “many pundits take the increasing cost as evidence that the system is too expensive. But increasing expenditures could just as well be a symptom of success.”

And he hits a homerun with a clear, concise, and common sense explanation. “The reason Americans spend more than their grandparents did is not waste, fraud and abuse, but advances in medical technology and growth in incomes. Medical science has consistently found new ways to extend and improve lives. Wonderful as they are, they do not come cheap.”

The issue of access to innovation is crucial – and the topic of a new paper from the Center for Medicine in the Public Interest, “Access to Medical Innovation: Obstacles and Opportunities.”

Consider the recent FDA approval of Merck’s Keytruda, the first of an eagerly awaited new class of cancer drugs that unleashes the body’s immune system to fight tumors.

As Andrew Pollack writes in the New York Times, “Cancer researchers have been almost giddy in the last couple of years about the potential of drugs like Keytruda, which seem to solve a century-old mystery of how cancerous cells manage to evade the body’s immune system.”

There are many roadblocks beyond those of discovery and development. The complicated and conflicting dynamics of politics, perspectives on healthcare economics, of friction between payers, providers, manufacturers, and regulators, the battle for better patient education, and the need for a more forceful and factual debate over the value of innovation all create the need for a more balanced and robust debate.

Shortly before his death, I had the privilege of a private meeting with Nobel laureate Joshua Lederberg. We talked about the state of applied science, the prioritization of development science, biomarkers, and a host of other future-oriented issues. At the end of the meeting he put everything into perspective in a single sentence. He leaned over the table and said, “The real question should be, is innovation feasible?”

Let’s hope so. Innovation equals hope.

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The Fight Against Cancer

09/05/2014 01:30 PM |

CMPI in participating in a national awareness campaign to accelerate the fight against cancer.   

Mylifeisworthit.org, our patient-centered project to promote access to innovative medicine was featured today in a USA Today supplement.   It can be found at http://futureofcancercare.com


Each year a quarter of million people, many of them children, die from cancer or cancer related complications because of delay and indifference. 

Many have as little as a 6 percent chance of living five years and none have more than a 50 percent chance of living that long.

Meanwhile, it takes two years just to put together a clinical trial to study potential treatments for cancer and another 8 years to complete one.   In the time it takes to organize a clinical trial over 200000 people with cancer will die.  By the time a clinical trial is finished, 2.5 million people, including 200,000 children with cancer will die.  

Defenders of the status quo claim we need to go slow to ensure patient safety.  But it is evident that millions of people are being protected to death.

In fact, the situation facing people living with many tumor types is just like the challenge people living with HIV faced nearly 40 years ago.  Then, as now, people without effective therapies are dying in less time than it takes to test new medicines. 

At the height of the movement to speed up access to HIV drugs, people living with HIV forced the Food and Drug Administration to dramatically slash the time required to study potential HIV medicines.   These changes were made to allow patient’s maximum hope for cure and the opportunity for some control over our destiny.

Today, researchers and doctors know more about the underlying mechanisms of cancer than they did about HIV.  It is now possible to deliver precise therapy to people on the basis of that individual's tumor. There are no 2 different cancers that are the same anywhere. Just like there are no 2 individuals who have the same DNA, that's the same for a tumor.

And while HIV patients used notebooks and faxes to share data, today’s patients have the digital ability to learn, join, share and take part in advocacy and research faster than ever before.

Cancer is the current system of clinical trials. These require any new drug/treatment to successfully complete three phases of trials aimed primarily at assuring the safety of new drugs. The phase 1 trial is frequently completed in a few months, involves only a few patients and a few hundred thousand dollar investment. The phase 2 and 3 trials for any given new treatments however take up to ten years or more and tens of millions of dollars, all to obtain additional safety data on a few hundreds to a thousand or so patients.

Yet, most cancer trials are conducted as if these technological advances did not exist. People are herded into studies that replace a deep understanding of how to match medicines to tumors with randomized trials (including placebos) that assume everyone responds the same way and for the same amount of time.    It’s as if we ignored someone’s shoe size and instead told everyone to try on the same to try a size 6 to see if a shoe fits.  

There are treatments now in phase 3 trial with years to go before any possibility of approval, but where the early phase I results of ten years ago are still big improvements over the treatments approved by the FDA many years ago known for these cancers. Only those lucky few are can qualify for the phase 2 and phase 3 trials will get this treatment until the treatment receives FDA approval years from now. What is gained by denying such a treatment to patients right now? Today. What justifies the withholding of a possibly life extending treatment to anyone who needs it and is willing to accept any the possibility that it might not help?

Such an approach and such delay is neither scientifically or morally supportable particularly to people living with a  tumor types without effective therapies.  Indeed, what we seek has been for HIV drugs and can be done under FDA’s existing regulatory authority.

Nearly 500,000 people each year are told they have a form of cancer that will kill them in two years or less because there is no effective treatment.  Each year, half of all people who die of cancer.   Yet it takes ten years to bring a new cancer therapy to patients. We can save lives faster and give people living with cancer hope that can last a lifetime. 

Here's some actions we can take to reduce the time drastically.

• Empower the Food and Drug Administration to approve new drugs after phase 1 for patients whose tumors respond to a specific treatment in those early studies.  Such treatments should be granted conditional approval with the requirement that they are then monitored very carefully in real world settings.   NCI funding should be increased to support this approach.

• Increase funding for cancer prevention programs, including early detection and identification of genetic mutations that increase cancer risk.

• Accelerate access to and reduce the cost of experimental treatments to patients, especially children, who have run out of treatment options and can’t wait for or excluded from clinical trials.  Patients should be able to use any experimental treatment provided that all data (except the patient’s identity) is made freely available to other patients, researchers and the FDA.   Companies that make products available under this program could receive accelerated approval for that drug or another drug under FDA review. 


• Eliminate health insurance cost-sharing schemes that create barriers to cancer patients’ ability to access potentially life-saving medicines by passing legislation that provides equal access and insurance coverage for ALL anti-cancer regimens and eliminates fail first policies forcing patients to switch from one drug to another.

If you believe it's important to accelerate access to innovative therapies, join us at http://www.mylifeisworthit.org


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Cognito ergo IPR

09/05/2014 01:00 PM |

From the pages of the Detroit News:

Foreign patent abusers undermine U.S. drug industry

The biggest roadblock to American pharmaceutical innovation isn’t science. It’s intellectual property rights.

Drug companies are struggling to finance the research and development of new treatments. And their difficulties are being seriously exacerbated by some of America’s closest trading partners. Foreign officials are repeatedly violating basic intellectual property protections and siphoning away valuable investment capital.

These abuses need to stop. The drug industry is a crucial part of the American economy. We can’t afford for it to cease innovating.

The largest drug companies typically invest over one billion dollars to develop a new medication. The drug development process usually takes 10 to 15 years. And many of these investments don’t pay off. Only about a fifth of the 5,000 compounds that enter pre-clinical testing every year even make it to human trials. And among those only one in five will ever get approved by the FDA.

Pharmaceutical companies are willing to undertake such costly risk because they hope to eventually recoup these investments once the drug is approved by the FDA. Patents provide innovators with a limited period of market exclusivity, in which competitors are barred from creating low-cost knock offs. The resulting sales help offset those massive upfront expenses.

But these patent protections are now under threat by some major U.S. trading partners.

Our neighbor to the north, Canada, has established uniquely burdensome hurdles for pharmaceutical patent-seekers. Usually, a company seeking a foreign patent must simply prove that its product is useful and new. But Canada demands that patent-seekers overcome an additional hurdle, in which they must “soundly predict” with a high level of specificity the underlying product’s ultimate function.

This creates a Catch-22 for pharmaceutical developers.

In order to “soundly predict” the use of a new medicine, they must gather extensive evidence from clinical trials. But by the time this lengthy trial process is completed, the drug is no longer exotic or new — and so it may no longer meet the “novelty” standard.

Canadian courts have embraced this double-bind and overturned the patents for more than 20 innovative medicines in the last decade. And even more drugs might be at risk of losing their patent protections. Canadian regulators are still allowed to revoke patents years after they’ve been awarded.

India, another major American trading ally, has also undermined the intellectual property rights of pharmaceutical companies. Indian courts have revoked or otherwise broken at least 14 drug patents in the last two years.

For example, although Pfizer’s cancer drug Sutent enjoys patent protections in 90 countries, Delhi recently revoked its patent. A judge unilaterally ruled the drug wasn’t sufficiently “inventive.” Regulators have invoked equally suspect grounds for snapping patents in other decisions, including the need to protect domestic manufacturers.

These patent violations undermine long-term drug innovation. By carving into companies’ ability to recoup its R&D investments, they reduce the funds (and the appetite) for new medical exploration. Firms will be less likely to take that huge risk entailed by the creation of breakthrough treatments and the supply of new life-saving drugs will diminish.

Peter J. Pitts, a former Food and Drug Administration associate commissioner, is president of the Center for Medicine in the Public Interest.

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Getting schooled on drug pricing

09/04/2014 07:26 AM |

Thought provoking lead story in this week’s edition of BioCentury, Back to School Issue: Paying the piper. Here’s the challenge:

Pharma has lost its pricing power in many countries, as evidenced by reimbursement authorities' willingness to delay or outright deny access to drugs whose costs are deemed unacceptable. Now, the availability of a costly drug in the U.S. that could be given to millions of people has sparked the strongest backlash against drug pricing the industry has yet faced - in the last major market where the government has not adopted any form of drug price controls, according to the U.S. Department of Commerce.

Last year, in "Facing Reality," Back to School argued biopharma companies can no longer assume the market will support premium pricing, even for drugs that deliver meaningful and measurable improvements over the standard of care.

This year, BioCentury's 22nd Back to School essay goes on to argue that the last bastion of free pricing is crumbling, and biotech and pharma had better start experimenting with new pricing models based on value for money while they still have the chance.

And here’s the conclusion:

Back to School does not suggest drug pricing and reimbursement can be fixed easily, and certainly not by the drug industry on its own. Finding approaches that will get new and better medicines to patients sooner, that compensate companies for the health benefits their drugs provide and that don't break the bank will come only through vigorous and collaborative experimentation.

Nevertheless, unless it pursues experiments with the explicit goal of creating a win-win for payers and patients as well, the drug industry can expect controls on prices and utilization to be applied with indiscriminate force in markets worldwide.

Biopharma's brightest minds are hard at work discovering and developing breakthrough medicines. It will be a pitiful shame if patients are denied access because the industry's brightest marketing minds are not creative enough to devise models that will enable healthcare systems to pay for these transformations in healthcare.

What industry needs are brave individual first-movers to get to work on new pricing models that will preempt a cost-plus system and preserve incentives for innovation.

Back to School has described three places where drug companies can blaze the trail.

First, they should pioneer value-based approaches that wed drug prices to the patient- and payer-defined value of outcomes, rather than to the volume of drugs consumed or, in the emerging worst case scenario, the costs to develop and produce them.

Second, drug companies should take the lead on making risk-sharing a reality, not just a catch-phrase for discounts and rebates, and make investments in the kinds of enabling systems that can support appropriate use and reimbursement of medicines, as well as inform development of tomorrow's innovative drugs.

Third, drug companies should spearhead the development of payment models that enable health systems to absorb the cost of cures by enabling payment over the period in which benefits accrue, as long as the drugs continue to work.

As has been the case with Back to School's recommendations in years past, these experiments will require robust collaboration with unfamiliar and even hostile partners. Many will fail.

But the reward for taking those risks will be a menu of pricing and reimbursement options that ensure companies are compensated for the value of both incremental and breakthrough innovations, and that drive revenue and profit by extending access to a bigger pool of patients.

The entire article (and it is definitely worth a read) can be found here.

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Raising the stakes for fakes

09/03/2014 09:31 AM |

Via Fierce Pharma – and they buried the lead

EU agents seize more than €10M worth of counterfeit drugs, arrest 12

Authorities from 8 European Union countries, backed by Europol and Eurojust, have arrested a dozen suspects and seized more than €10 million worth of counterfeit drugs, mostly fakes of erectile dysfunction drugs that an organized crime group was selling online. The raid, announced Monday, came after an investigation that lasted nearly two years.

According to Europol, law enforcement folks from Austria, Belgium, Cyprus, France, Hungary, Slovakia, Spain and the United Kingdom conducted simultaneous raids. They were backed up by Europol and Eurojust. In addition to seizing several million pills, which it estimated were worth well in excess of €10 million, the agents seized cash and luxury cars and froze bank accounts that contained €7.5 million.

The investigation originated in Spain, which was able to provide information for probes in Austria, France and the U.K., Europol said in a statement. It said the fakes originated in Asia, home to many of the counterfeit drug operations.

While erectile dysfunction drugs have long been a target of counterfeiters selling online, Europe is also seeing organized crime move into stealing and faking high-priced drugs, like cancer meds. Authorities this spring warned that vials of Roche's  cancer med Herceptin that had been stolen in Italy were showing up across the continent with little or none of its active ingredient.

Because some of the organized crime rings behind counterfeits are based in Europe, the FDA has assigned one of its criminal investigation officers to Europol in The Netherlands. The FDA estimates that 40,000 to 60,000 domain names could be tied to illegal online pharmacies at any given time, and that this number is in a constant state of flux.

Not mentioned in the article – but of relevance – is that in 2013 US National Association of Boards of Pharmacy found that only 257 of 10421 online pharmacies are legally legitimate businesses (less than 2.5%).  The remainder either have bogus registration credentials or domain names that make them “suspect.”

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The ultimate in regulated speech

09/02/2014 12:34 PM |

Looking for a great job? How about Director of Communications for CDER?

Here are the details:

FDA's Center, for Drug Evaluation and Research (CDER) is searching for exceptional candidates for the position of Director of the Office of Communications (OCOMM). The Office currently has over 100 employees. OCOMM is the central hub for communication expertise, in CDER, focused on the development of consistent messaging to inform and educate the multiple audiences. The Office has a variety of responsibilities including the planning, coordination and evaluation of the policies, procedures, programs in the strategic outreach and communication about drug-related requests.

The incumbent serves as Director, Office of Communications (OCOMM) for the Center for Drug Evaluation and Research (CDER). The Director provides leadership and direction for all Center internal/external communications. The Director is responsible for the creation of a climate for cooperative work relations, and support and understanding of the CDER program objectives. Additionally, the Office of Communications Director advises and counsels the Center Director and CDER leadership on external and internal communications relative to the exchange of information and is the liaison external groups.

Qualifications:

Applicants should possess an advanced degree in Communications, Marketing, Public Relations, or Public Affairs.

Successful candidates are those that have experience working closely with highly-credentialed people. They must have substantial experience in Communications, Marketing, Public Relations, and/or Public Affairs. Knowledge of pharmaceuticals is a plus. The candidate should be persuasive, influential, and have the ability to ask the right questions.

Location: Silver Spring, Maryland

Salary: GS-15, $124,995-157,100 Salary is commensurate with qualifications and experience. A full Federal benefits package is also available including: leave, health and life insurance, retirement, long term care insurance, and Thrift Savings Plan (401K equivalent).

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FDA: Let's talk about pain

09/01/2014 11:23 AM |

Much chatter about a pending FR notice announcing an FDA public meeting on pain medications. Good idea or bad idea?

Well, as the Beltway saying goes, where you stand depends on where you sit. On the one hand there’s the side of science and the public health. Is open public debate useful? Absolutely. And timely.

On the other there are those with less than altruistic interests. The tort bar for one and ambitious politicians for another.

What does “success” look like? For the FDA and like-minded public health advocates, success means advancing safer and more safely used pain medications. For learning and accelerating applied science.

For others it means headlines and a hefty payday.

Which story is more media-friendly? If you don't know the answer to that one, do some internet research on the vaccine/autism link and the debate over SSRIs and teen suicidal ideation.

(Hint – science doesn’t win media inches.)

Who will testify at the FDA meeting? Who will serve on the expert panels? Who will the FDA participants be?

It’s good news that the session will not be an advisory committee. No votes are likely to be taken. Nor will it probably be a Part 15 affair where only “listening” is required of the agency.

It’s FDA leading – but the devil is in the details.

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Nomenclatura

08/28/2014 08:49 AM |

If you're looking for some light beach reading over the long weekend, may I recommend the lastest Policy Forum paper from the Food Drug and Law Institute (FDLI).  The title, Biosimilar Nomenclature: Can We Achieve the Truth, the WHole Truth, & Nothing but the Truth? says it all.

Enoy the paper -- and have a great Labor Day.  Read More & Comment...

Scheduling Scheduling

08/27/2014 09:10 AM |

The House is expected to vote on The Improving Regulatory Transparency for New Medical Therapies Act (H.R. 4299). (It has already been approved by the Energy & Commerce Committee.) Companion legislation is expected to be introduced in the Senate soon. The legislation would strengthen the Controlled Substances Act by requiring the DEA to “schedule” medicines 45 days after it receives the FDA’s scheduling recommendation for a new drug.

(The average time between FDA approval and DEA’s final scheduling is about eight months -- and it sometimes takes more than a year.)

The issue at hand is that patients have not been able to access a growing number of new treatments because of a lack of predictable schedule review times – and particularly long evaluation times associated with DEA scheduling decisions.

It’s time for that to change.

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In sync? Not entirely.

08/26/2014 07:00 AM |

The California Assembly just passed (by a vote of 72-0) AB2418, legislation for medication synchronization that “promotes policies designed to improve patient medication adherence.” An earlier draft of the bill included measures that would have given about one million Californians whose health plans require them to order prescriptions through the mail an option to waive that requirement -- but some strong business interests threw a fit. Fortunately, the bill does specifically addresses pharmacy synchronization, a tried and true methodology for significantly improving medication compliance. It now heads to the Governor’s desk.

It should be a no-brainer for Governor Brown -- but the Assembly’s unanimity isn’t as complete as the vote makes it look.

The mail order measure was strongly supported bya wide swath of patient groups, seniors’ organizations, provider associations, labor unions, pharmacies, and business support. Alas, it was killed by the profits over patients crowd consisting of Aetna, American’s Health Insurance Plans, Association of California Life and Health Insurance Companies, Blue Shield of California, California Association of Health Plans, Express Scripts, and the Pharmaceutical Care Management Association.

Their rationale: mail order is cheaper – at least in the short-term. The Pharmaceutical Care Management Association has launched a campaign against the bill that includes the release of a study finding that mail-order pharmacies save about 16% more than brick-and-mortar pharmacies, including $500 million in savings next year on regular prescription medications. However, the study also noted that stand-alone prescription drugs often were more costly through mail-order pharmacies.

According to the U.S. Centers for Medicare and Medicaid Services (CMS), the estimated cost of synchronization to Part D sponsors is meager $0.5million, while the savings to Part D sponsors and beneficiaries is $1.8 billion. And there will be an overwhelming reduction in overall health care costs because of improved patient outcomes due to enhanced medication adherence, which should lead to higher quality ratings for a health insurance plan.

The Assembly vote notwithstanding, Governor Brown’s signature on the bill isn’t assured. And the lobbying is intense. The health plans and PBMs mentioned above are still strongly opposed and actively lobbying for a veto

Governor Brown’s signature to AB 2418 will result in better health and lower costs.

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Facts, Damn Facts, and Opioids

08/25/2014 09:38 AM |

The New York Times reports that, The City of Chicago and two California counties are challenging the drug industry’s way of doing business, contending in two separate lawsuits that “aggressive marketing” by five companies has fueled an epidemic of addiction and cost taxpayers millions of dollars in insurance claims and other health care costs.

Do they know more than OPDP? Have they contacted the FDA? Do they have legal standing or is this a case of Federal Preemption? None of these questions are addressed in the article.

Also left unmentioned is that Purdue Pharma (mentioned at great length in the Times article as a defendant), is working with the U.S. Attorney's Office, Central District of California to help convict felonious pharmacists who operated an opioid diversion ring.

As Aldous Huxley famously said, “Facts do not cease to exist because they are ignored.”

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Opioid Upscheduling, the Precautionary Principle, and the Law of Unintended Consequences

08/22/2014 07:15 AM |

Joshua Lederberg, the Nobel Prize Laureate once observed that the failure of regulatory, legal and political institutions to integrate scientific advances into risk selection and assessment was the most important barrier to improved public health.  

Lederberg noted that in the absence of such changes,  "the precedents affecting the long-term rationale of social policy will be set, not on the basis of well-debated principles, but on the accidents of the first advertised examples."

Policies and regulations that seek to limit risk are often shaped by the immediate fear of sensational events. This perspective is commonly called "The Precautionary Principle" which in various forms asserts that unless innovators can demonstrate that a new technology is risk free, it should be not allowed into the marketplace.  Moreover, any product that could possibly be dangerous at any level should be strictly and severely regulated. 

Which brings us to yesterday’s announcement that the federal government (led by the DEA) is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

The new rules mean that drugs like Vicodin, Lortab and other generic versions will be subject to the same prescribing rules as painkillers like codeine and oxycodone. Patients will be limited to one 90-day supply of medication and will have to see a health care professional to get a refill. Additionally, in many states prescribing authority will be limited to physicians, not nurses or physician assistants.

Will this limit abuse? That’s a theory. What's a fact is the negative impact it will have on the tens of millions of Americans who suffer from chronic pain.

Last September, CMPI held a conference on the issue of opioid pain medications. One of the panelists was Cindy Steinberg, the National Director of Policy and Advocacy for the US Pain Foundation. Here’s what she had to say about upscheduling:

That’s going to mean that people need to see their doctor at least four and sometimes 12 times a year just to obtain a script because of the very strict requirements on Schedule II medications. The hydrocodone combinations are now Schedule III and if they are upscheduled, in Massachusetts for example, where Schedule II scripts expire in 30 days and cannot be written for more than a 30 day supply, many people in my group are that are taking hydrocodone combinations medications would have to see their doctor every 30 days for a script.

They now see their doctor perhaps twice a year. So, they would have to go see their doctor 12 times per year. People have a hard time finding a pain doctor period, let alone getting an appointment.

Somebody in my group was referred to a pain specialist in January of 2012 and the first appointment she was able to get was in December of 2012. She had to wait almost an entire year to see a pain doctor. So how are we going to handle the number of people that are going to need appointments to get their medications? In Massachusetts, as I mentioned Schedule II scripts expire in 30 days and by federal law cannot be refilled. I have a person in my group that has osteonecrosis. He was an early heart transplant patient and the steroids he had to take to maintain his organ transplant resulted in osteonecrosis which has eroded every joint in his body. He’s had multiple joint replacements and lives with a very high degree of pain. His wife has to drive him to the doctor now every 30 days in order to get his Schedule II medication because he needs to get a physical script. And that’s going to happen to many people if these Schedule III medications are rescheduled. And as I mentioned, given all those extra appointments, think about what that is going to do to healthcare costs.

Upscheduling will result in tighter restrictions for patients who really need the medications, more paperwork for physicians and a heavier workload for pharmacists. Abusers and criminals rarely follow regulations.   Read More & Comment...

openFDA and Open Sesame on 21st Century Pharmacovigilance

08/20/2014 08:50 AM |

This past June, the FDA launched openFDA, a new initiative designed to make it easier for web developers, researchers and the public to access large, important public health datasets collected by the agency.

According to the agency, the initiative is the result of extensive research with internal officials and external developers to identify those datasets that are in recurrent demand and are traditionally fairly difficult to use. Based on this research, the FDA decided to phase in openFDA beginning with an initial pilot program involving the millions of reports of drug adverse events and medication errors that have been submitted to the FDA from 2004 to 2013. Previously, the data was only available through difficult to use reports or Freedom of Information Act requests.

And this week the FDA unveiled a new Application Programming Interface that offers data from the agency’s database containing medical-device adverse event reports, going back to 1992.

The crowd-sourcing of adverse event data may or may not yield interesting results, but it’s a good place to start. It represents an opportunity for the agency to begin designing a more evolved approach to 21^st century pharmacovigilance.

For the rest of the story see OpenFDA: The Key To Moving Pharmacovigilance Into the 21st Century in the new edition of PM360.
 

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