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Study Design and the Drug Development Process
To the Editor
A Viewpoint by Dr Djulbegovic and colleagues1 claimed not only that randomized clinical trials (RCTs) aremore ethical but that greater use of randomized designs throughout the drug development process would “improve the efficiency, ie, enable faster development ofnew, successful treatments.” However,RCTs are outdated for several reasons. First,RCTs are inadequate to evaluate cancer therapies. Genomic analysis is uncovering the tremendous heterogeneity of what previously were considered single diseases. Genomic analysis of cancers of individual patients is disclosing the large number of mutations, and thus targets, within one person. Developing RCTs for targeted therapies would be difficult and timeconsuming, prolonging the wait for effective treatments.
Second, RCTs are a less efficient and accurate method of establishing which treatments work.
A recent study demonstrated that RCTs fail to predict or improve outcomes when evaluating multicausal diseasenetworks or treatments orwhen assessing which particular interactions are relevant.2 Rather than increase the use of RCTs, we propose an increase in the use of N-of-1 studies, which are based on simulations that rapidly sort through billions of possible interactions
at the clinical, genomic, and biological levels to arrive at predictive models of multicausality. This approach has identified candidate markers, which have been successfully used in clinical trials.3 These studies also have predicted the most effective treatments for patients based on a particular genotype
and medical history when RCTs have not.4 Increasing the use of RCTs would add to the cost and time required to developand use new products. Other analytic methods more quickly and precisely match patients to treatment.
1. Djulbegovic B, Hozo I, Ioannidis JPA. Improving the drug development
process: more not less randomized trials.JAMA. 2014;311(4):355-356.
2. Eppstein MJ, Horbar JD, Buzas JS, Kauffman SA. Searching the clinical fitness
landscape.PLoS One. 2012;7(11):e49901.
3. Wu C-C, D’Argenio D, Asgharzadeh S, Triche T. TARGETgene: a tool for
identification of potential therapeutic targets in cancer.PLoS One.
4. Garnett MJ, Edelman EJ, Heidorn SJ, et al. Systematic identification of
genomic markers of drug sensitivity in cancer cells.Nature.
2012;483(7391):570-575. Read More & Comment...
Per a report in Inside Health Policy:
CMS Holds Off Changes To Protected Rx Classes, Preferred Pharmacies, Limits On Plan Offerings
CMS kept its promise to put on hold key pieces of its proposed drug and Medicare Advantage proposed rule: the final regulation unveiled Monday does not rescind protected drug classes, does not open preferred pharmacy networks and does not limit the number of plans that insurance companies may offer.
CMS' proposed changes to regulations for Part D and Medicare Advantage plans were controversial on several fronts, and both parties attacked the rule, although sometimes over different provisions. After proposing the rule Jan. 6, CMS received more than 7,500 comments. In an unusual move, CMS Administrator Marilyn Tavenner told Congress in March that the agency would indefinitely put some of the most contentious measures on hold.
The strongest bipartisan opposition was against the agency's proposal to take away the protected status of three drug classes. Lawmakers, patient advocates and others argued that all drugs in those classes must be available because not all of the drugs in those classes work for all patients.
The final rule states that, although some commenters praised CMS for trying to apply criteria for drug categories or classes of clinical concern, no one supported the actual proposed criteria. Conversely, CMS did receive significant opposition to our proposed criteria.
"We are not finalizing any new criteria and will maintain the existing six protected classes," the rule states.
CMS received a lot of opposition to its proposal to open up preferred pharmacy networks, although that opposition came primarily from Republicans, who complained that CMS was opening the door to government interference between plans and pharmacy contracts, and the drug makers and pharmacy benefit managers that negotiate those contracts. Smaller community pharmacies, which usually are left out of preferred pharmacies, lobbied for the measure.
Preferred pharmacy networks provide lower cost sharing to beneficiaries who buy from those preferred pharmacies. The pharmacies agree to lower cost sharing in return for the greater volume of sales they get by offering lower prices. CMS proposed to allow beneficiaries to get the same cost-sharing at nonpreferred pharmacies. CMS thought that would simply give lower cost sharing to more beneficiaries, but others, including congressional Medicare advisers, warned that it would end the very preferred pharmacy networks that CMS was trying to expand upon.
"This lower cost sharing was subject to certain conditions that seemed straightforward to us at the time, but which have proven to need clarification," CMS states in the final rule.
Instead, CMS is exploring restrictions on preferred pharmacy networks in a separate document, called the call letter. Primarily, CMS wants to require that preferred networks reduce drug costs paid by plans in order to prevent Medicare from paying more for what intuitively should reduce Medicare spending.
CMS also is holding off on its proposal to limit the number of plans offered by sponsors of stand-alone drug plans. The final rule makes a case for restricting insurance companies to one basic plan and one enhanced plan per coverage year and for limiting the type of coverage offered in those two plans.
"Nevertheless, the comments have given us reason to conduct further analysis of this issue and continue our close observation of the developments in the Part D market," the regulation states.
However, CMS is following through with the proposed rule's measure to limit parent organizations to one prescription drug plan sponsor contract per region.
What the final does do:
• It requires Part D prescribers to enroll in Medicare. "CMS is requiring that physicians and eligible professionals who prescribe covered Part D drugs be enrolled in Medicare, or have a valid record of opting out of Medicare, in order for their prescriptions to be covered under Part D. Requiring prescribers to enroll in Medicare would help CMS ensure that Part D drugs are only prescribed by qualified individuals," the rule states, adding that it allows extra time, until June 1, 2015, for that requirement to take effect.
• It simplifies MA risk-adjustment data validation (RADV) audit appeals by combining error rate calculation appeals and medical record review-determination appeals. "The streamlined process will reduce administrative burden on both MA plans and CMS," the rules states.
• It lets CMS, its antifraud contractors and other oversight agencies the ability collect information directly from pharmacy benefit managers, pharmacies and other entities that contract or subcontract with Part D sponsors to administer the Medicare prescription drug benefit. This provision, which the HHS inspector general recommended, aims to provide faster access to records for investigations of Part D fraud and abuse.
• It revokes Medicare enrollment from physicians who abuse their prescribing rights.
• It expands incentives for activities that promote improved health, efficient use of health care resources and prevent injuries and illness.
• It allows the release of more privacy-protected Part D data. CMS is releasing to the public more unencrypted, prescriber, plan and pharmacy identifiers contained in prescription drug event records.Read More & Comment...
NORD Representative Is One of Five Experts Invited to Testify Before Key Congressional Subcommittee
WASHINGTON DC; May 21, 2014-----Frank J. Sasinowski, representing the National Organization for Rare Disorders (NORD), testified yesterday before the U.S. House Energy and Commerce Health Subcommittee on advancing the development of treatments for Americans with unmet medical needs.
The hearing was focused on the new 21st Century Cures initiative announced April 30, 2014, by Energy & Commerce Committee Chairman Rep. Fred Upton (R-MI) and member Rep. Diana DeGette (D-CO) to accelerate the discovery, development, and delivery of innovative new medical treatments.
The experts who testified discussed recommendations in the President's Council of Advisors on Science and Technology (PCAST) Report on Drug Innovation pertinent to the new 21st Century Cures initiative.
Sasinowski, a longtime NORD advisor and board member, noted that accelerating the development of safe, effective medical therapies and cures has special significance for people with rare diseases, most of whom have no approved therapy at this time.
"I am reminded daily that the 30 million Americans affected by rare diseases have a vital and urgent need for faster development of therapies," he said.Read More & Comment...
Let’s talk about Copaxone, Dingell-Grams, and Chevron Deference.
There are many interesting aspects of this issue, not the least of which is the FDA’s pathway to predictably address the many regulatory issues surrounding nonbiologic complex drugs (NBCDs) – such as Copaxone.
And the FDA issues have a crucial impact on patient care – specifically therapeutic interchangability. Payers are watching.
As the agency has stated (most recently in a response to a letter from Representative John Dingall):
FDA believes that it is possible for manufacturers to develop generic versions of complex large-molecule drugs that can be demonstrated to have the “same” active ingredient as the reference listed drug and meet the requirements for generic approval under section 505(j) of the FD&C Act and FDA regulations … FDA currently believes that it may be possible, with some complex products, for an applicant to demonstrate that its proposed drug product meets the standards for approval as a generic drug under section 505(j).
‘It is possible.” “May be possible.” Now that’s a real conditional response.
Importantly, the agency notes, “It is important to note that analytical methods, data analysis, and pharmaceutical manufacturing capability continue to evolve.”
As far as human trials are concerned, the FDA writes that, “in appropriate cases, FDA can ensure that a generic version of a complex large-molecule product approved under section 505(j) is therapeutically equivalent to the reference-listed drug without clinical safety or efficacy data because the product has been shown to satisfy the statutory sameness standard and other requirements of section 505(j).
Clearly not every case with every NBCD is identical (Lovenox certainly comes to mind), but greater clarity on how the agency review process is certainly needed. Each circumstance – although unique – cannot be forever de novo.
And the policy precedents for biosimilars are also important to consider.
On legal front, the FDA is being given chevron deference by the courts.
Per www.fdalawblog.net …
In a May 14, 2014 Order following a hearing earlier that day, Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia granted on ripeness grounds FDA’s Motion to Dismiss a lawsuit brought by Teva Pharmaceutical Industries Ltd. and Teva Neuroscience, Inc. (collectively “Teva”) alleging that FDA’s May 2, 2014 denial “without comment” of a December 2013 Citizen Petition (Docket No. FDA-2013-P-1641) concerning COPAXONE (glatiramer acetate injection) violates the FDC Act and the Administrative Procedure Act. At the same time, Judge Huvelle denied as moot Teva’s Motion for a Preliminary Injunction.
As we previously reported, Teva filed the lawsuit seeking declaratory and injunctive relief after FDA denied “without comment” several citizen petitions Teva submitted to FDA since 2008 concerning the approval of ANDAs for generic COPAXONE and considered by FDA under the citizen petition procedures added to the FDC Act at Section 505(q). According to Teva, “FDA’s tactics make it virtually impossible for a court to provide aggrieved petitioners with meaningful relief before they are harmed irreparably.” Each patent listed in the Orange Book for the 20MG/ML strength of COPAXONE is set to expire on Saturday, May 24, 2014. After patent expiration, FDA could make ANDA approval decisions.
The D.C. District Court almost immediately denied Teva’s Motion for a Temporary Restraining Order after it was filed, and scheduled a May 14th hearing on Teva’s Motion for a Preliminary Injunction. Teva pitched its requested relief as follows:
The relief Teva seeks could be structured in either of two ways. First, this Court could simply enjoin the FDA from approving any purported generic version of Copaxone® until the Court has conducted an expedited trial on the administrative record defined by Congress and ruled on the merits of Teva’s petitions. In the alternative, this Court could employ a variant of the procedure Judge Bates first crafted in the Hi-Tech case, permitting the Agency to finally offer its views on the issues Teva has raised on a negotiated timetable—though whatever views the Agency might offer would be, by the law’s plain terms, outside the administrative record and thus entitled to no deference—but enjoining the Agency from acting to approve any purported generic version of Copaxone® until this Court can provide meaningful judicial review of the critically important matters Teva has raised.
The so-called “Bates procedure” in Hi-Tech Pharmacal Co. v. FDA, Case No. 08-cv-1495, was established by Judge John D. Bates, who has been particularly critical of FDA’s handling of exclusivity decisions, to give the parties (i.e., FDA and a drug manufacturer) a chance to sit down in court where FDA would reveal an exclusivity decision, thereby allowing a potentially aggrieved generic manufacturer the opportunity to challenge that decision (see our previous post here).
FDA, in the Agency’s Motion to Dismiss, argued that Teva’s lawsuit should be dismissed for a litany of reasons. According to FDA:
Not only are Teva’s claims unripe and unjusticiable for want of standing, but Teva has not established that it will suffer certain, great, and irreparable injury in the absence of a preliminary injunction. If Teva ever suffers the loss that it claims it will here, such loss will be a small percentage of its multibillion dollar portfolio of generic and brand drugs, and thus would not threaten or even seriously injure the business. And finally, the balance of harms weighs against the entry of preliminary relief because Teva’s desire to further delay generic competition does not outweigh FDA’s interest in the thoughtful and careful exercise of its generic approval decisions without premature judicial interference.
FDA’s efforts to get Teva’s lawsuit tossed were backed by briefs (here and here) filed by Intervenor-Defendants Mylan Pharmaceuticals Inc., Sandoz Inc., and Momenta Pharmaceuticals, Inc., which reportedly have ANDAs pending at FDA for generic COPAXONE.
After a hearing that went on for over three hours, Judge Huvelle rendered her decision: granting FDA’s Motion to Dismiss and denying Teva’s Motion for a Preliminary Injunction. Her decision was grounded in previous decisions in Pfizer Inc. v. Shalala, 182 F.3d 975, 980 (D.C. Cir. 1999), AstraZeneca Pharmaceuticals v. FDA, 850 F. Supp. 2d 230 (D.D.C. 2012), and Mylan Pharmaceuticals Inc. v. FDA, 789 F. Supp. 2d 1 (D.D.C. 2011), where ripeness was a central issue to deciding the cases. Judge Huvelle also refused to employ the “Bates procedure;” however, she did ask for a 24-hour “heads-up” from FDA on ANDA action. According to Judge Huvelle at the May 14th hearing:
What we have here is a fact-specific complicated, complex scientific issue that has to be determined; and it hasn’t been determined yet. To force them to decide the really difficult scientific issues at this time, I don’t have the power to do so, and it has to wait until there is a concrete application of the requirements for bioequivalency and sameness. When that is determined, then Teva has the right to have a review of the administrative record and a speedy decision, and they can fight at that point about whether they're entitled to a preliminary injunction. That is the only protective-window ability the court has. Although if, in fact, we have an approval of an ANDA and this case comes back to this Court, I can assure you the FDA will have a matter of days to get together the administrative record because that is the only thing that holds us up. . . .
Your right here is to get a final agency action. That doesn't mean that it has to be the final agency action on what you want. They have said that we need to take it up in the context of a specific ANDA. That is an action. We haven’t got to that point yet. You cannot force us to take a premature action on this.
The Court rests on jurisdictional grounds and will grant the motion to dismiss, deny the [Preliminary Injunction]. To the extent that anything is going to happen, I am requiring the FDA . . . to give the Court notice so that we’re available to decide the difficult issues that come up here. I’m not in the position of doing what Judge Bates did because you don’t have a deadline, you’re not in that position, but I certainly think that as a courtesy to all people, you should give us 24 hours’ notice before if you’re going to issue anything . . . just to let us know.
The 24-hour notice from FDA is apparently intended to allow the Court to adequately prepare and schedule for what may be the next Teva lawsuit – this time challenging an FDA decision to approve ANDAs for generic COPAXONE. That decision could come any time after May 24th.
Stay tuned.Read More & Comment...
According to the European Federation of Pharmaceutical Industries and Associations new “Manifesto for an Integrated Life Sciences Strategy in Europe,” drug manufacturers in Europe are missing out on opportunities for growth and patient outreach because they are failing to understand the value and potential of mobile health applications.
Per EFPIA’s director general Richard Bergström, “This is going in the direction of better patient compliance, adherence and motivation as well as an emphasis on health literacy and mobile apps … We need to find a way to unlock both the perceived and real regulatory hurdles, because I am not sure that the regulatory barriers are that high, and I think we are just being held back by conservatism.”
Bergström’s views are supported by the EU’s executive European Commission, which launched a Green Paper and consultation on mHealth in April this year. Its purpose is to examine existing barriers and issues related to mHealth deployment and help identify the right way forward to unlock its potential inside the 28-nation system.Read More & Comment...
Dear GO, CDER, and CBER staff:
We are pleased to announce an initiative to further our goal of ensuring that the public has access to quality pharmaceuticals. This initiative aims to deepen our reliance on trusted regulators outside of the United States who provide equivalent public safety and quality protection. This work is critically important and requires a dedicated FDA team to collaborate with our colleagues in European institutions and member states.
Managed jointly by GO, CDER, and CBER, this initiative will build upon our existing relationships with the European Medicines Agency (EMA) and member states of the European Union (EU), the European Commission (EC), and the European Parliament. It will complement the ongoing work of CDER, CBER, ORA, and OIP to enhance pharmaceutical quality through international collaboration, and also FDA’s work in implementing the FDA Safety and Innovation Act.
Dara Corrigan to Lead Initiative as Senior Counselor for Global Operations and Policy
Effective May 18, Dara Corrigan will lead this mutual reliance initiative. She will leave her position as director of FDA’s Europe Office, but remain in Brussels, in the role of senior counselor for global operations and policy. Dara will report directly to Howard Sklamberg, deputy commissioner for global operations and policy. She will provide strategic advice and counsel to the FDA Commissioner and other FDA senior executives. Don Prater, DVM, will serve as acting director, FDA Europe Office.
Dara brings a wealth of experience and knowledge of U.S. and EU laws and regulations that govern pharmaceutical products. Before serving as director of FDA’s Europe Office, she was FDA’s associate commissioner for regulatory affairs, overseeing one of FDA’s largest operating units and managing FDA’s inspection program. She also has held a variety of senior positions in HHS, and served as an attorney with the U.S. Department of Justice and at the law firm of Arnold & Porter.
CDER OCOMM’s Julie Zawisza and CDER OC’s Helen Saccone to Join Team
Dara will oversee a team that will be dedicated to mutual reliance activities and that will report to GO, CDER, and CBER. The team will include Julie Zawisza, who has served as director of CDER’s Office of Communications since 2008, and Helen Saccone, who has been a special assistant in the Office of Manufacturing and Product Quality (OMPQ) in CDER’s Office of Compliance since 2011.
Julie holds a master’s degree in international science, technology, and public policy from the George Washington University and has more than 14 years of FDA experience. Before working in CDER, she worked in communications at CBER and was the head of FDA’s press office in the Office of the Commissioner. Julie also has worked for health professional and industry associations in communications and advocacy roles, and as a medical technologist at major medical centers in Washington, D.C. and Ann Arbor, Michigan.
Helen Saccone, Pharm.D., has worked in FDA for six years. Before coming to FDA, she worked as senior manager for education at the American Pharmacists Association and as a pharmacist for the D.C. Department of Health, conducting pharmacy and hospital inspections, as well as providing technical assistance on D.C. regulations. She holds a doctoral degree in pharmacy from Rutgers University. The team also will draw upon the work of other experts in CDER, CBER, ORA, OIP, and OCC.
We are delighted that these seasoned and accomplished individuals have agreed to lead the charge, and we have every confidence that the program is in very capable hands going forward. We invite you to congratulate Dara, Julie, and Helen, and offer them your support.
Building on Existing Pharmaceutical Quality Efforts
We want to thank our FDA staff members who continue to work so diligently on improving pharmaceutical quality and safety for the American public. The initiative announced today builds on the Agency’s ongoing efforts to enhance collaboration between FDA centers and ORA, and to bolster our resources around drug quality.
We are very excited about this programmatic direction and its potential to leverage our relationships with our European partners and capitalize on our shared interests as regulators to strengthen mutual reliance and ensure pharmaceutical quality for the U.S. market.
In the coming months, you'll hear more about all of this as the team embarks on its first set of activities. A special town hall will be scheduled soon to give FDA staff an opportunity to ask questions about this initiative and how it fits in with the Agency’s pharmaceutical quality efforts.
Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy
Janet Woodcock, Director, Center for Drug Evaluation and Research
Karen Midthun, Director, Center for Biologics Evaluation and ResearchRead More & Comment...
It’s not only “biosimilar” or “interchangeable” any more.
The FDA (per a report in BioCentury) said the extent of data requirements for a biosimilar product will depend on the agency's confidence in the level of similarity to the reference product, according to draft guidance published Tuesday.
Based on comparative analytical data, FDA will characterize its assessment of biosimilarity into one of four levels -- not similar, similar, highly similar or highly similar with a fingerprint-like similarity -- depending on the type, nature and extent of any structural and functional differences revealed.
Additional pharmacologic studies would be required to show that the identified difference is "within an acceptable range to consider the proposed biosimilar product to be highly similar to the reference product." FDA said only products in the top two tiers would meet the statutory requirement for analytical similarity under the Biologics Price Competition and Innovation Act of 2009. Products in the top two tiers would then only require "targeted and selective animal and/or clinical studies to resolve residual uncertainties" to demonstrate biosimilarity. In addition, these data could be used to extrapolate clinical data for additional indications.
Obvious implications here for the naming debate.
Analytical studies and at least one clinical pharmacokinetic study intended to support a demonstration of biosimilarity must include an adequate comparison of the product directly with a U.S. licensed reference product. According to the draft, a sponsor may use a non-U.S. licensed comparator product in certain studies to support this comparison. The sponsor must provide adequate data to establish "an acceptable bridge" between the non-U.S. licensed comparator product and the U.S. licensed reference product.
At the May 6th House Energy and Commerce Committee’s 21st Century Cures Initiative roundtable, participants were asked what steps Congress could take to expedite bringing new treatments and cures to patients.
Francis Collins, director of the NIH, said that what is needed is a “steady trajectory of support” so that scientists are willing to take risks. But what does that mean?
Collins said that over the past 10 years, the NIH has lost 20 percent of its purchasing power. His belief is that this loss has cost jobs and caused a lack of enthusiasm in our investigators, he said.
20%? That sounds like a statement worth investigating – because the NIH budget has grown significantly over the past decade.
“If we could have confidence of a stable trajectory for support, that would mean the world for an enterprise that is currently flagging,” he said. Not sure precisely what that means but, again, perhaps a study of how NIH is spending it’s current budget would help identify the strengths and weaknesses of its allocations – and the strategy behind them. After all, every dollar counts.
Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research (CDER), said one issue affecting biomedical innovation is the current clinical trials system for drugs.
“The clinical trial system we have is not a system,” Woodcock said. “It takes years and it exhausts investigators.”
Woodcock said the FDA is starting to look at clinical trial networks that are already set up and funded. Testing a new drug in a clinical trial network is faster and “saves a lot of money,” she said.
Additionally, per Dr. Woodcock, since multiple new drugs are studied by the network, “you can do head-to-head comparisons of products.”
She also said there is a lot of innovation in drug manufacturing, and that the FDA will hold a meeting to pursue this avenue in a few weeks.
Another area that the FDA is focusing on is the Critical Path Initiative. Its goal is to bring innovative, high priority therapies to market quickly.
“There is a lot of research that needs to be done on things like biomarkers that would” speed the development of products, Woodcock said.
And, according to Margaret Anderson, executive director of FasterCures (an advocacy group aimed at improving the medical research system that is affiliated with the Milken Institute), “The appropriated dollars that go to the FDA are extremely valuable, and they are not enough.”
This past Sunday, I participated in a point/counterpoint in the pages of the Chicago Tribune with Dr. Kenneth Polonsky, Dean of Biological Sciences Division at Pritzker School of Medicine, and executive vice president, medical affairs, at the University of Chicago.
Dr. Polonsky’s perspective was, more or less, the same as Dr. Collins’, “more money equals more cures.” If only it was so simple. My view (IMHO) is somewhat more nuanced.
And here’s mine:
Outside Opinion: Federal funds should go to medicine-makers
By Peter J. Pitts
Is more federal funding for the National Institutes of Health the best bang for the buck when it comes to using precious tax dollars to advance public health? No.
The NIH budget is about $30 billion. But what does that buy? Where do discoveries that advance public health really come from? Some do come from NIH-funded research — but not nearly the majority. The engine of innovation is the biopharmaceutical industry, which spends in excess of $50 billion annually on research and development. It's not a competition; the NIH and industry complement each other's efforts. But context matters.
The NIH focuses on basic research, the study of fundamental aspects of phenomena without specific applications. The biopharmaceutical industry addresses most of its R&D toward clinical research, science focused on the actual development of new medicines. The NIH provides grants to academic institutions. Industry employs the scientists who do the work and, increasingly, funds academic research.
But there's a problem. While universities love NIH dollars, they are less enamored of industry resources. Why? One reason is that NIH funding counts toward achieving tenure, while similar dollars from biopharmaceutical companies do not. Durbin's legislation would disincentivize more industry-academic partnerships. More government spending is not always the mother of invention.
As the Prairie State's great Sen. Everett Dirksen once (allegedly) quipped, "A billion here, a billion there, and pretty soon you're talking about real money." Some $10 billion annually could be allocated elsewhere to achieve broader access to newer, more targeted therapeutic medicines (and $5 billion could go toward the NIH's good work, hardly a paltry sum). The Food and Drug Administration should be No. 1 on the list to get more money.
The FDA regulates more than 25 percent of the U.S. economy, yet operates on an annual budget of $4.7 billion (about $2 billion generated by industry user fees). The budget's federal funding portion is about one-tenth the NIH's. Why hasn't Durbin proposed additional tax dollars for the FDA's programs on advancing regulatory science, expedited review pathways or more ready access to experimental medicines for desperately ill patients? The FDA doesn't even need $10 billion a year for 10 years to become our nation's leading force in health care innovation. Some $1 billion a year would do the job quite nicely. As to the remaining $9 billion, the line forms to the left.
Alas, headlines for hyped and misleading "NIH-funded cures" are far sexier than those for "more money for drug regulation." They may not be inversely important, but they are equally urgent in advancing 21st-century American health care.Read More & Comment...
China is adopting a free market solution to drug shortages.
China will scrap caps on retail prices for low-cost medicine and is moving toward free-market pricing for pharmaceuticals, after price controls led to drug quality problems and shortages in the country.
The Wall Street Journal reports that Chinese leaders want health care to be more accessible and affordable, but there have been unintended consequences in attempting to ensure the lowest prices on drugs. For instance, many pharmaceutical companies registered to sell the thyroid medication Tapazole have halted production in recent years after pricing restrictions squeezed out profits, experts say, creating a shortage.
The lesson for US lawmakers is clear – artificially low prices are the major cause drug shortages.
Perhaps its time for our lawmakers to revisit the legislative solution proposed in Senator Orrin Hatch’s Patient Access to Drugs in Shortage Act. There are three key codicils:
1. Price Stability
The Hatch bill would change the Medicare reimbursement rate for generic injectable products with 4 or fewer active manufacturers from ASP + 6% to Wholesale Acquisition Cost in order to achieve market price stability.
2. Medicaid/340B Rebate Exemption
The bill exempts generic injectable products with 4 or fewer active manufacturers from Medicaid rebates and 340B discounts in order to achieve market price stability.
3. Extended Exclusivity
Manufacturers who hold an approved application for a drug that would mitigate a shortage can extend by 5 years any period of exclusivity, even if the drug is eventually moved from drug shortage designation.
It’s embarrassing that the world’s leading free market economy (that’s us) hasn’t learned the Econ 101 lessons our friends in China are now implementing to solve the problem of drug shortages.Read More & Comment...
HEP, HEP, Hooray!
CDER Director, Dr. Janet Woodcock. responding to criticism about the high price of breakthrough drugs, said that the agency is working towards approving more effective treatments for diseases like cancer and hepatitis. Reacting to controversy around the price of the breakthrough Hepatitis C drug Sovaldi, Dr. Woodcock discussed the potential decrease in societal costs and increase in patients' quality of life.
"I think we have to in some ways think about this as a transition period," she said during a panel discussion about the breakthrough designation. "We may have to put a big down payment down now to get something really good."
She highlighted the cost to society and burden on patients in dealing with the side effects and morbidity of having Hepatitis C. "I really do believe we need to drive toward curing, but you have to have a transition period, she said. "We are driving toward a cure with hepatitis."
Woodcock further advocated getting these drugs on the market so they could be combined with other products to drive toward cures. "In cancer, I think we have to recognized this is version 1.0, but we're going to get there," she said. "And to get there we can't hold back. We can see that cure."
The battle for the heart and soul of 21st century health care is the battle over innovation. And nothing short of victory is acceptable. To borrow an over-used adjective from the world of global climate change, we must protect “sustainable” innovation.Read More & Comment...
Representative Anna Eshoo (D, CA) and the late Senator Edward Kennedy worked long and hard to write, lobby for, and pass the Biologics Price Competition and Innovation Act.
Unlike many of her congressional colleagues, Representative Eshoo has the creds to ask some tough questions of the FDA. She’s also smart enough to know the right questions to ask.
Unlike some of her fellow members who are swinging their political heft, trying to lobby the FDA on science-based questions, Ms. Eshoo is asking for clarification on the timing of a decision.
That is an appropriate and important question.
Representative Eshoo, in a letter to FDA Commissioner Hamburg asks (among other things) that the agency …
“Share with me the FDA’s timeline for the release of the draft guidance on naming and interchangeability.”
That’s a fair question from a member of Congress who deserves a prompt answer.
Observe due measure, for right timing is in all things the most important factor.
HesiodRead More & Comment...
I’ve just returned from Riyadh, Saudi Arabia where both the Saudi FDA and the Ministry of Health are embroiled in the current MERS (coronavirus ) crisis.
It’s already cost the Minister of Health his job and many citizens are questioning the ability of the government to protect their wellbeing. It’s also an international news story that does not reflect well on the Kingdom.
Another reason to reexamine the state of overall health preparedness – and not only in Saudi Arabia.
A good place to start is with a serious conversation on 21st century pharmacovigilance. Let’s start with definitions.
According to the WHO, “Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
Okay as far as it goes. But this is a very 20th century perspective. Perhaps a more progressive view comes from our regulatory cousins at the MHRA, “Assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use.”
The significant difference is that most regulatory officials still view PV through the lens of adverse events. The MHRA definition, however, broadens the conversation to include safe use. That’s 21st century pharmacovigilance.
What does this have to do with the coronavirus?
It speaks to the need of public health officials to be both the guardians of the public health as well as the watchmen. And that takes more than vigilance – it takes resources. It also takes a village – a public health village – comprised not just of public officials, but physicians, nurses, pharmacists, hospitalists, patients, and caregivers.
And it’s got to be more than MedWatch.
How much sooner could the coronavirus been identified and dealt with if the Saudi Ministry of Health had a more robust mechanism for post-market surveillance that went beyond adverse events?
But it’s not just the Saudis.
The FDA is establishing an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic and over-the-counter drugs, CDER Director, Dr. Janet Woodcock said at the Bloomberg health-care summit. The FDA is talking with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection, she said.
The agency now collects such information only during inspections. The thrust of the effort would be to head off potential concerns before the agency wields penalties such as banning products from troubled factories. “We want to use leading indicators. These people aren’t in trouble yet but they could be.”
Forewarned is Forearmed.Read More & Comment...
Yet another reason to stop calling it "compassionate use" and start calling it by it's proper name -- "expanded access."
The Wall Street Journal reports …
The FDA Says It’s More Compassionate Than You Think
Even as drug makers and desperate patients increasingly battle over access to experimental medicines for life-threatening conditions, Food and Drug Administration officials argue the agency is doing its part to make things right.
In the wake of some recent high-profile cases that made television news and prompted social media outcries, the FDA has released data showing that nearly every request it gets for “compassionate use”’ is approved.
The term refers to an FDA program in which individuals who are seriously sick and lack options are able to gain access to a medicine being developed, even though they are not enrolled in a clinical trial. For this to happen, a patient’s physician must first receive permission from the drug maker testing the medicine. From there, the physician must seek what amounts to a blessing from the FDA.
In recent years, the FDA has been very agreeable. In the fiscal year ended last October, the agency approved 863 requests, or 99 percent of all cases reviewed, according to FDA data. And one-third of those were approved on an emergency basis. In fact, the agency has approved 99 percent of all requests since October 2009. On average, 932 requests were endorsed annually since then.
“I think the numbers speak well for the program,” says Richard Klein, director of the patient liaison program in the FDA Office of Health and Constituent Affairs.
In reality, though, the process is not working as some patients would hope. Drug makers sometimes deny requests for compassionate use because they want to stick with strict trial criteria needed to win FDA marketing approval for their medicines. An unexpected patient reaction, for instance, might jeopardize a drug’s chance of success. In some instances, a company claims not to have sufficient supplies to handle a large number of requests.
This is what happened recently when a small biotech company called Chimerix denied a Virginia family. Their 7-year-old son, a cancer survivor, developed a viral infection after a bone marrow transplant and they hoped he would benefit from an antiviral drug Chimerix is developing. But repeated rejections became a publicity debacle as criticism was directed at the company and the FDA program as well.
The FDA said it intervened by working with Chimerix to design a pilot study to include the boy. That pilot study is now underway, according to a Chimerix spokesman. But an FDA spokeswoman says this was not the first time the FDA took such a step. Meanwhile, the FDA’s Klein says the agency is developing a new draft guidance, or blueprint, for handling expanded access cases.
“The agency only provides the pathway,” he says. “If a company is not willing to entertain a request [for compassionate use], then it doesn’t come to us. Most of the time, we only know about the applications where companies are willing to make drugs available. The numbers we have don’t include the times when companies say no. And there’s not a lot of data to say what the outcomes of these situations are.”
Maybe not. But perhaps FDA officials should find a way to require drug makers to report their compassionate use decisions – approvals and rejections – so the public can see the extent to which the program is having its intended effect.Read More & Comment...
According to Robert Jamison, PhD, professor of anesthesia and psychiatry at Harvard Medical School and pain psychologist with Brigham and Women’s Hospital, mobile medicine is helping chronic pain patients cope with and manage their condition thanks to new smartphone apps, which can track patients from a distance and monitor pain, mood, physical activity, drug side effects, and treatment compliance.
Per Jamison, smartphone apps are helping the shrinking ranks of pain specialists treat and monitor rapidly increasing populations of chronic pain sufferers. “Today the ratio is one pain specialist for every 10,000 patients, but mobile technology allows for easy time-effective coverage of patients at a low cost, offering significant opportunities to improve access to health care, contain costs, and improve clinical outcomes,” he explained.
At the American Pain Society annual meeting, Jamison presented results of his research on smartphone apps, developed at Brigham and Women’s, for monitoring pain patients. He found that internet-based cognitive behavioral therapy could significantly decrease pain levels, improve function, and decrease costs compared to standard care.
“Online networks, for example, can promote communication, distraction, information sharing, self expression and social support,” Jamison said. “We also believe online networks decrease feelings of withdrawn behavior and instill a greater willingness to return for treatment.”
Jamison added that electronic diaries maintained by patients are more effective than paper diaries for evaluating pain levels, daily activities, treatment compliance and mood.
Jamison said that while few studies have been conducted on text messaging as a pain management tool, texting has proven to be effective for managing patients with diabetes, hypertension, asthma, smoking cessation and weight loss.
In his ongoing research, Jamison is studying 60 patients with chronic cancer and non-cancer pain who use a pain management smartphone app. “We hypothesized that the pain management smartphone app will help providers track patients and reduce emergency department visits and hospitalizations by 50 percent,” said Jamison.
A key feature of the pain management app is daily pain tracking in which patients are asked five questions about their pain, activity interference, sleep, mood, and overall status on a sliding scale of 1 to 10, and compare these with baseline ratings. Should pain ratings significantly increase from baseline or reach 9 or 10, the patient gets an immediate response that the pain specialist has been contacted.
“The pain management smartphone app can deliver non-pharmacological, cognitive behavioral treatment as well as prompt patients to stay active, comply with therapy, and develop pain coping skills,” Jamison reported. He added that the smartphone data can be summarized and transmitted every day into the patient’s electronic medical record.
Jamison noted that the average response rate to text messages to pain patients is 70 to 90 percent and that high responders show improved pain levels.Read More & Comment...
PITTS: America’s pain and opioid problem
Millions risk overdose death as they seek relief from suffering
Former Canadian Prime Minister Pierre Trudeau once said, "There's no place for the state in the bedrooms of the nation." What's the appropriate place for the state in our nation's pharmacies and medicine chests — particularly regarding for opioid pain medications?
Earlier this month, the Food and Drug Administration (FDA) took a big step in making sure that the number of opioid drug-related deaths doesn't continue spiraling out of control by approving a drug called Evzio. A take-home, one-time-use autoinjector, Evzio is the first drug of its kind. It releases a narcotic antagonist called naloxone to reverse the effects of an opioid overdose until emergency medical help arrives.
Fast-tracking drugs like Evzio, which will help dramatically reduce the number of opioid-overdose deaths, is just one part of a complex solution. Improved provider and patient education is crucial. Caregivers need to know how to properly prescribe based on an individual's pain-management needs, and patients need to know how to properly follow their treatment plans. If not, addiction will continue consuming lives.
Opioids work by targeting the same receptors in the brain as heroin, resulting in feelings of euphoria. The numbers speak for themselves: People are hooked.
According to the National Institute on Drug Abuse, 5.1 million people reported abusing prescription painkillers. Teenagers account for a large share of the rising prevalence of opioid abuse — they report abuse or dependence problems at six times the rate of folks 50 and older. Eight percent of high school seniors report using Vicodin nonmedically. Curtailing the frequency of opioid-related abuse — and at an early age — must remain a priority.
It's not just a user problem. It's a provider problem, too.
In the United States, the use of opioids as first-line treatment for chronic pain conditions doesn't follow either label indications or guideline recommendations. Fifty-two percent of patients diagnosed with osteoarthritis receive an opioid pain medicine as first-line treatment, as do 43 percent of patients diagnosed with fibromyalgia and 42 percent of patients with diabetic peripheral neuropathy. Payers often implement barriers to the use of branded, on-label non-opioid pain medicines, relegating these treatments to second-line options. The result is a gateway to abuse and addiction.
How do we fight the twin dangers of opioid misuse and addiction?
In her statement on opioid abuse last month, FDA Commissioner Margaret Hamburg explained that the FDA will continue to work collaboratively with "state and local governments, public health experts, health care professionals, addiction experts, researchers, industry and patient organizations" to help reduce the risks of opioid misuse, abuse, addiction and overdose.
The first step is providing physicians with extensive clinical guidelines and educational opportunities for prescribing opioids. For example, continuing medical education classes are offered by the Substance Abuse and Mental Health Services Administration to make sure that physicians are up to date on the importance of creating individualized patient treatment plans.
Last year, the FDA announced labeling changes and post-market study requirements for opioids in an attempt to begin more accurately prescribing and treating patients requiring opioid pain medications. Labeling changes mark one important step in highlighting the value of physician-to-patient communication and individualized patient pain-management programs.
In addition to providing patients with materials on proper use of opioid medications, patients should also be educated about proper drug disposal. The National Survey on Drug Use and Health found that painkillers used for nonmedical reasons were obtained from friends or family members 70 percent of the time.
Prescription-drug monitoring programs offer another solution. The programs are state databases that make sure patients are filling prescriptions belonging only to them, are taking the right dosages, and are not receiving prescriptions from multiple physicians.
Continued research into drugs that can reverse the symptoms of opioid overdose and ensuring patients have access to naloxone agents such as Evzio will also reduce the occurrence of overdose-related deaths. Mitigating the occurrence of opioid overdose could also save our health care system upward of $70 billion per year.
The FDA took a big step this month in approving a take-home drug that temporarily reverses the effects of opioid overdose. However, the battle over misuse, addiction and overdose is far from over. Health care providers and policymakers need to continue working toward a solution — or the line between the orange bottle in the medicine cabinet and the syringe in a back alley will become increasingly blurred.
Peter Pitts, a former Food and Drug Administration associate commissioner, is president of the Center for Medicine in the Public Interest. Read More & Comment...
Washington, D.C. – The Office of the United States Trade Representative (USTR) has released its annual “Special 301” Report on the adequacy and effectiveness of U.S. trading partners’ protection and enforcement of intellectual property rights (IPR). Significant elements of the 2014 Special 301 Report include the following:
• USTR highlights growing concerns with respect to the environment for IPR protection and enforcement in India and other markets.
• The Report expresses ongoing, serious concerns about the protection and enforcement of trade secrets with respect to China, and emerging concerns in other markets.
• USTR announces that it will conduct Out-of-Cycle reviews to promote engagement and progress on IPR challenges identified in this year’s reviews of India, Kuwait, Paraguay and Spain.
“The United States is an innovation economy. We are the global leader in research and development. We have given rise to some of the most creative, inventive and entrepreneurial businesses in the world, contributing significantly to advances in global health, the development of the digital economy and the education and entertainment of billions of people worldwide. More than 30 million Americans owe their jobs directly to these and other innovative industries. USTR is fully committed to unlocking opportunity for those Americans to share their inventions and creations with people all over the world without their work being infringed or misappropriated,” said Ambassador Michael Froman.
“Release of the 2014 Special 301 Report marks 25 years since USTR published the first Special 301 ‘Fact Sheet.’ In that time, we have achieved dramatic changes in the international intellectual property landscape. The Obama Administration is committed to meaningful and sustained engagement with trading partners -- from China to India to Canada -- with the goal of resolving intellectual property-related concerns so that Americans and American firms can compete on a level playing field in those markets.”
“I would like to congratulate the Governments of Italy and the Philippines on their removal from the Watch List. Both were named in the first Special 301 Fact Sheet and in many annual reports since, but today we acknowledge their accomplishments and encourage them to continue their progress,” Ambassador Froman concluded. “Likewise, we congratulate Israel on its removal from the Watch List earlier this year.”Read More & Comment...
The Times of India quotes Pfizer's senior vice-president for global policy and international public affairs, Justin McCarthy, that "a series of regulatory initiatives and legal challenges have frayed relations between the Indian government and global pharmaceutical firms,” and urged the government to "shift from using destructive IP policy as an access strategy.”
Mr. McCarthy and Pfizer ought to be applauded for bringing to light this important policy issue where the Indian government wants to bury the truth. However, I would add one nuance to the policy discussion. India’s IP grabs aren’t an access strategy – it’s a doomed effort at domestic industrial policy.
A wolf in sheep’s clothing shouldn’t be called a sheep.Read More & Comment...
California may be the poster child for the Medical Home but, when it comes to pharmacy synchronization, it’s a healthcare house divided: the House of hospital pharmacists on the one side, patients, physicians, and community pharmacists on the other.
Currently pending in front of the State Assembly is AB2418, legislation that would promote “promotes policies designed to improve patient medication adherence.”
Specifically the bill addresses pharmacy synchronization, a tried and true methodology for significantly improving compliance and adherence. The bill is being opposed by hospital pharmacists or better known as the “anti-adherence” organization.
Adherence is a problem of behemoth proportions. According to a report in the report conducted by the New England Healthcare Institute, not taking medications as prescribed leads to poorer health, more frequent hospitalization, a higher risk of death and as much as $290 billion annually in increased medical costs. There isn’t any one way to solve the problem. Education? Sure, but that only gets you so far. Apps and other social media interventions? Yes. Phone call reminders from physicians and pharmacists? Absolutely. But, alas, there is no one magic bullet.
Pharmacy programs seem to be the best way forward, and there’s hard data to back that up. Case in point – the successful Appointment-Based Model program being used at Thrifty White, a Midwest chain of pharmacies. (For more information on the Thrifty White program, see the article, Adherence and persistence associated with an appointment-based medication synchronization program, from the December 2013 edition of the Journal of the American Pharmacists Association.) Patients enrolled in the program have experienced 3.4 to 6.1 times greater adherence
Medication synchronization is a pharmacy service that improves patient adherence to prescribed medications by coordinating the refill dates for all of a patient’s chronic prescription medications so these can be picked up on the same date each month. It is estimated that 76 percent of Americans aged 60 and over use two or more medicines and 37 percent take five or more medicines. Patient and caregiver lives are simplified by eliminating multiple trips to the pharmacy each month. It also minimizes confusion over when a prescription is due to be refilled, and minimizes disrupting treatment through delayed or missed refills.
The Appointment-Based Model (ABM) is a voluntary medication synchronization prescription refill program that aims to improve patient adherence as well as the efficiency of the pharmacy operation. The ABM provides enhanced patient access through a streamlined process, opportunity for patient education on medication use, and greater pharmacist oversight to address potential contraindications, duplicate drug therapy, and errors.
What outcomes of medication synchronization?
· Improved adherence and time on therapy.
· Enhanced patient quality of care resulting from better adherence and understanding of medication therapy.
· Increased patient and pharmacist engagement allowing for greater monitoring and oversight of patient multiple-medication regiments.
· More efficient pharmacy operations. Medication synchronization has the potential to reduce administrative costs incurred by pharmacists and physicians long term as it streamlines medicine refill processes and helps pharmacies manage their inventories.
The American Medical Association adopted Resolution 801(I-12) in 2013, which encouraged relevant organizations, including insurance companies, to implement prescription refill strategies for patients with multiple prescriptions to reduce travel barriers to access to medicines.
The National Community Pharmacists Association (NCPA) and National Association of Chain Drug Stores (NACDS) have endorsed medication synchronization language for states to use when considering legislation. The American Pharmacists Association (APhA), American Cancer Society, Stroke Foundation, Epilepsy Foundation, American Academy of Pain Managemet and State Pain Policy Network are also educating their members on the benefits of medication synchronization.
According to CMS, The estimated cost to Part D sponsors is $0.5million and 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.
AB 2418 should be a no-brainer.Read More & Comment...
The other evening I attended a dinner hosted by National Journal and AstraZeneca on the topic of “patient centricity.” Those around the table were payers, patient advocates, providers, pharmaceutical executives, IT geeks, and policy wonks.
Patient Centricity is a phrase we hear a lot and it’s lost a lot of it’s meaning – kind of like “personalized medicine.” But (in the immortal words of Jim Croce) “It doesn’t have to be that way.” "PC" is the new Healthcare.
In fact, when you think about it, both phrases really mean the same thing – driving positive therapeutic outcomes and, not surprisingly, the assembled diners agreed. After all, payers want (and are willing – mostly) to pay for treatments that work, physicians want treatments that provide the maximum therapeutic benefit, pharmaceutical companies want their products to work as well as they possibly can (so that physicians want to prescribe them to more patients and payers want to pay for them), and patients (last but not least) want to get well as swiftly and completely as possible.
(And, it’s no accident that many in Pharmaland have found religion in the wake of the intense focus on the prices of certain specialty medicines. It is now more urgent than ever to protect “sustainable innovation.”)
The point to remember is that a patient who is diagnosed earlier and treated with the most efficacious treatment as soon as possible is the least expensive over time. Alas, this means we must think long-term – not a trait the healthcare system is known for.
Patient Centricity = Driving Outcomes. Personalized Medicine, the right medicine in the right dose for the right patient at the right time, drives outcomes. Patient Centricity is Personalized Medicine.
QED.Read More & Comment...
One day before her resignation, HHS Secretary Kathleen Sebelius sent a letter to Congressman Bill Cassidy (R, LA). One of the subjects was academic detailing.
According to Secretary Sebelius:
AHRQ no longer conducts an academic detailing program as of September 2013.
But what happened to tax dollars already spent?
In October 2010, AHRQ awarded five grants for a program on academic detailing and the “communication of CER results to physicians”. This program to disseminate CER findings is supported by $29.5 million from the American Recovery and Reinvestment Act (aka, “the stimulus package”).
* One contract, for $11.7 million, went to Total Therapeutic Management (TTM) and is specifically intended for physician outreach and education
The goal of this contract was to integrate AHRQ’s comparative effectiveness research, products, and tools into clinical practice through 9,000 on-site, face-to-face visits with clinicians, nurses, health plan formularies, benefit managers, and other healthcare professionals.
According to TTM’s Barry Patel, “the AHRQ AD project to disseminate CER findings was a 3 year program that was scheduled to end in September 30th. The project has been over since Sept 30th 2013 as scheduled.”
Other recipient’s of the $29.5 million were:
* Ogilvy Public Relations Worldwide, Healthcare Division: $18 million to create a publicity center and another contract for $8.6 to create regional dissemination centers.
* Prime Education (an educational design and accreditation company focused on continuing medical education programs): $4 million as a “continuing education award.”
* IMPAQ International (a social science research and consulting firm that specializes in impact evaluations for a client base of predominantly U.S. government agencies): $2.4 million to evaluate the impact of the other four contracts.
Maybe it’s time for Congressman Paul Ryan to call a hearing to discuss the, um, outcomes of that $25.9 million.Read More & Comment...