Not so sweet 16

07/23/2012 09:05 AM |

Tomorrow (Tuesday) the New York City Department of Health is holding a public hearing on Mayor Bloomberg’s call to ban sugar-sweetened drinks in portions over 16 ounces from New York City restaurants.

CMPI will be testifying.

In advance of the hearing, we took our roving camera to Central Park on a sunny Saturday to ask New Yorkers what they thought about the Mayor’s initiative.

Short answer – they don’t like it very much.

While recognizing the danger of obesity, those we interviewed were pretty blunt that regulation is a bad idea. They don’t see “more government” as the solution to changing the nutritional habits of the Big Apple.

Sorry Mike.

We will post this video (along with our testimony) shortly.

Bottoms up.

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Tim Possible

07/20/2012 08:40 AM |

In "How Fake Cancer Drugs Entered US," the Wall Street Journal reports on how two batches of counterfeit Avastin [bevacizumab] made their way into the US. The Journal specifically details the role played by the Internet pharmacy Canada Drugs.

In an email, FDA spokeswoman Sarah Clark-Lynn said, "The recent counterfeit incidents highlight vulnerabilities in the drug-supply chain and the possible health risk to patients if medical practices are choosing to buy unapproved drugs from a foreign supplier."

Hopefully veep wannabe Tim Pawlenty has been following this story.  When he was Governor of Minnesota, Pawlenty promised that his “drugs from Canada” Minnesota RxConnect program would serve some 700,000 people. According to  latest statistics, Minnesota RxConnect filled about 138 prescriptions a month. That's for the whole state, population 5,167,101.

That’s a nod to the smarts of the people in the North Star State. Recently Minnesota, state officials observed Canadian Internet pharmacies engaging in dangerous practices.

One pharmacy had its pharmacists check 100 new prescriptions or 300 refill prescriptions per hour, a volume so high that there is no way to assure safety.

One pharmacy failed to label its products and several others failed to send any patient drug information to patients receiving prescription drugs.

Drugs requiring refrigeration were being shipped un-refrigerated with no evidence that the products would remain stable.

One pharmacy had no policy in place for drug recalls. Representatives of the pharmacy allegedly said that the patient could contact the pharmacy about a recall "if they wished."

The FDA launched an investigation, confiscating thousands of drug shipments headed for the United States. Some of them were headed for Minnesotans who ordered them over the state's Web site.

When opened, nearly half claimed to be of Canadian origin, but "85 percent of them were from 27 other countries including Iran, Ecuador and China." And 30 of them were counterfeit.

One Minnesota resident discovered that one of his "Canadian" drugs came from Greece, and another came from Vanuatu, a small island in the South Pacific. "I never heard of the place," he said.

If Governor Pawlenty is, indeed, being vetted as a Romney running mate, hopefully he’s being asked about his stance on drug importation.

The full WSJ story can be found here.

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ATU, Brute?

07/19/2012 07:59 AM |

Per the MHRA’s plan to provide early access to some unlicensed products, our spy inside that agency reports that:

MHRA put together a proposal two years ago to allow medicines at the end stage of development trials earlier access to the market. The UK government was not interested in this and kicked it into the long grass. This scheme MHRA proposed at the time would be very like the French ATU scheme which has been in operation for the past ten years or so.

(For more on the French compassionate use program, see here.)

But when last year, the UK government started talking about its "growth agenda,” it decided that early access to new medicines was central to that agenda, it came back to the MHRA for help. We dusted down our previous scheme -- which is now out for consultation.

When the dust clears, we’ll be watching.

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The BPA Ban That Never Was

07/18/2012 04:27 PM |

The groups that have failed to turn BPA into a tort law cash cow are seeking to claim victory for a BPA phaseout that companies had in place for years industry... From the New York Times

F.D.A. Makes It Official: BPA Can’t Be Used in Baby Bottles and Cups

By SABRINA TAVERNISE

Published: July 17, 2012

It would be interesting to read and know more about what companies did to work with chemical companies to develop polymers that had the same benefits of BPA.    Maybe one day...   Read More & Comment...

Thriving without a license

07/18/2012 07:07 AM |

A dynamic proposal from our regulatory couusins at MHRA on early access to life-saving medicines.

The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) is asking for public comments on a proposal that would allow early access to unlicensed products for life threatening, chronic, or seriously debilitating conditions without adequate treatment options. MHRA said the program would apply to products with a "positive benefit-risk profile" that have completed Phase III testing. The agency estimates that 1-2 products per year would qualify for the program. MHRA added that in exceptional cases the program may be used for products at an earlier stage of development.

BioCentury reports that the proposal would allow sponsors to request an MHRA early opinion on an unlicensed product for a fee of L29,000 ($45,000). The opinion will be valid for one year and is renewable for L29,000 per year. Sponsors will not be allowed to advertise the products. Local level NHS organizations will be responsible for deciding whether to fund early access products from existing budgets.

MHRA proposed five ways of pricing early access products: conducting a full NICE cost-effectiveness review; setting the same price as that of the therapy for which the unlicensed product directly substitutes; allowing companies to set their own price as long as the impact on the NHS budget is below a predetermined threshold; supplying products for free; or determining prices on a case-by-case basis. Comments are due October 5. MHRA said the program could launch by year end.

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Another Weapon Against HIV

07/17/2012 02:05 PM |

NPR's excellent health blog has a great discussion about Truvada, the HIV retroviral that the FDA just approved as a preventive treatment for a specific sub group of HIV patients:   http://www.npr.org/blogs/health/2012/07/17/156868446/deciding-on-truvada-who-should-take-new-hiv-prevention-pill?ps=sh_stcathdl


The debate about the cost is a false one.  At a retail price of $13k a year,  Truvada is a bargain compared to what we lose and what we spend on treating HIV. 
My bet is that insurers will pay for this targeted preventive treatment.  As Mark Duggan has shown: previous HIV treatments have reduce Medicaid spending by 16 percent and increase life expectancy by a factor of three.    

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Wither "the Deal?"

07/17/2012 06:45 AM |

From the fine  folks at the DIA …

Supreme Court's Health Care Decision was Announced, Now What Does it Mean for the Biopharmaceutical Industry?



To cure your headache over the sometimes confusing decision and more confusing commentary about the Affordable Care Act Supreme Court decision, hear three veteran health law and policy experts explain what to expect in the wake of the decision. They will detail what the case decided, what changed and what didn’t, then explore how it may affect biopharma companies, as well as the political implications and what Capitol Hill might do next as health reform evolves.

Join us on July 26 from 11:00 AM-12:30 PM ET for the Will the PhRMA Deal Stand and What Happens Next? What the Biopharmaceutical Industry Needs to Know in the Wake of the Supreme Court Decision Upholding the Affordable Care Act webinar where you'll hear experts cut through the hype to consider the real effects of the Supreme Court's decision on the drug, device and biopharma industries.

Moderator:
 John F. Kamp, JD, PhD 
Executive Director
, Coalition for Healthcare Communication

Presenters:
 Peter J. Pitts, Former FDA Associate Commissioner 
President, Center for Medicine in the Public Interest

Arnold I. Friede, Former FDA Associate Chief Counsel, Principal, Arnold I. Friede & Associates

Richard Manning, PhD 
Partner
, Bates White Economic Consulting

Agenda and Event Details
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1-215.442.6199
Ellen.Diegel@diahome.org

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Balm's Away

07/16/2012 06:48 AM |

Is there no balm in Gilead?  Is there no physician there?
-- Jeremiah, viii. 22

Remember when the President said that, under his healthcare reform plan, “If you like your doctor, you can keep your doctor”? Well, that turned out to mean – “If your doctor accepts your new insurance plan, you can keep your doctor.” As my grandmother used to say, “A half truth is a whole lie.”

Now, we must grapple with an even more serious attack on the doctor/patient relationship – essential health benefits. Under the law, insurance policies sold to individuals and small businesses must cover 10 so-called “essential health benefits,” including hospitalization, maternity care and prescription drugs. (See the complete list of benefits here.) But each state will determine how insurance companies cover those benefits in that state.

Or will they?

Representatives Henry Waxman (D-Calif.), Sander Levin (D-Mich.) and George Miller (D-Calif.), ranking members, respectively, on the House Energy and Commerce, Ways and Means and Education and the Workforce Committees, sent a letter to HHS Secretary Kathleen Sebelius (PDF) about the essential health benefits bulletin. The lawmakers contend that when they wrote the Patient Protection and Affordable Care Act, the essential health benefits package was intended as a federal decision, and that one of the primary goals of the healthcare reform law was to create a consistent and comprehensive level of coverage for Americans nationwide.

So, according to these lawmakers, it’s Washington that’s going to decide what’s essential and what’s not – further disempowering a physician’s ability to practice medicine. It’s another step towards one-size-fits-all medicine – the polar opposite of personalized medicine.

This issue of essential health benefits – what they are and who calls the shots – is at the crux of the battle against government-run healthcare.

Late last week, according to BioCentury, a group of 28 Representatives sent a letter to HHS expressing concern about a CMS proposal that may allow insurers to cover only one drug per therapeutic class under the Affordable Care Act's essential health benefits (EHB) plans. The group said a requirement that insurers cover only one drug per therapeutic class would be "overly restrictive," adding that the policy ignores patients' clinical needs and would lead to poorer clinical outcomes and greater healthcare costs.

The group urged HHS to require the plans to cover "all or substantially all" drugs for six therapeutic classes: antidepressants, antipsychotics, anticonvulsants, antiretrovirals, antineoplastics and immunosuppressants. The group noted that products in these classes are not clinically interchangeable, and that the products often have a high discontinuation rate because of lack of efficacy or side effects, requiring patient access to and coverage for multiple products in the same therapeutic class. CMS implemented the same requirement for Medicare Part D in 2006.

While “what” is defined as “essential” is, of course, crucial – the issue of “who” is paramount.

Do you really want Henry Waxman telling your doctor how to practice medicine?

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Pre-Marketing Surveillance

07/15/2012 08:36 PM |

Here is the FDA's statement on it's monitoring of certain employee computers:

The FDA takes very seriously our responsibility to safeguard the confidential information we receive each year from the industries we regulate as well ensuring the ability of employees to voice their concerns.

Shortly after learning that confidential information had been released outside the agency, the FDA initiated monitoring of a small number of FDA employees for whom the agency had evidence suggesting that they might be responsible for the unauthorized disclosure of proprietary information.

The monitoring was limited and intended to determine whether confidential commercial information had been inappropriately released to the public. The agency's monitoring was limited to the government-owned computers of five employees and was only intended to identify the source of the unauthorized disclosures, if possible and to identify any further unauthorized disclosures. These steps were taken because FDA, in order to serve the public health of the American people and respect the proprietary interests of the manufacturers, is statutorily required to protect commercial confidential information and trade secrets. The FDA is legally prohibited from releasing this information without legal authorization.

FDA did not monitor the employees’ use of non-government-owned computers at any time. Neither members of Congress nor their staffs were the focus of monitoring. At no point in time did FDA attempt to impede or delay any communication between these individuals and Congress. Employees have appropriate routes to voice their concerns without disclosing confidential information to the public, and FDA has policies in place to ensure employees are aware of their rights and options.

The FDA's ability to protect and promote public health in the U.S. is tied to our ability to protect confidential information. This allows us to work with industry to ensure the quality of FDA-regulated products and also encourages outside stakeholders to provide us with information that would allow the agency to identify any wrongdoing.    Read More & Comment...

Generic Substitution

07/14/2012 06:27 AM |

News from FDA:

The Office of Pharmaceutical Science (OPS) is proud to announce the selection of Gregory P. Geba, M.D., M.P.H., as Director of the Office of Generic Drugs (OGD) effective July 15, 2012.

Dr. Geba has served in senior-level clinical/managerial positions in the pharmaceutical industry for the past 15 years. He most recently served as Deputy Chief Medical Officer for Sanofi US, where he provided medical and scientific leadership and managerial direction to a staff of approximately 500 multidisciplinary scientific and regulatory professionals engaged in drug development activities across all therapeutic areas, as well as to the company’s field medical group.

He has contributed to the registration of more than 20 currently marketed drugs or devices across multiple therapeutic areas. In so doing, he successfully employed his working knowledge and demonstrated practical application of drug manufacturing processes, current quality and risk management processes, and standards relevant to FDA’s laws and regulations. He brings extensive clinical research experience, including leading or serving as the key point in filing new drug applications, biologic license applications, and promotional studies comparing efficacy and effectiveness of novel biopharmaceuticals versus standard of care (including regimens containing branded or generic drugs), and has provided or supervised key safety updates and presentations to FDA Advisory Committees. Dr. Geba’s experience also includes leading medical affairs activities while serving in a variety of senior-level positions. His scope of responsibility in those activities included contribution to the design of experimental protocols and assessment of data from pre-clinical, animal, and first-in-human studies; design, implementation, analysis, and interpretation of phase 2a proof-of-concept and 2b dose ranging studies; and production of important comparative effectiveness and safety data when assessing benefit-risk relationships during phase 3, phase 3b, and phase 4 studies.

Dr. Geba received his medical degree from the University of Navarre and his M.P.H. from the Johns Hopkins Bloomberg School of Public Health. He joins OGD at an opportune time to lead our expanding generic program into a reorganization of both structure and process to improve coordination, communication, and efficiency, as well as enhance the Office’s ability to ensure that all generic drugs—which make up nearly 80 percent of prescriptions filled in the United States—are safe, effective, of high quality, and interchangeable with the brand name drug product/reference listed drug.

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The Pre-Sub Club

07/13/2012 07:28 AM |

Medical technologists -- welcome to the world of "non-binding advice."

The U.S. Food and Drug Administration plans to provide medical device makers feedback before they apply for marketing approval to help companies identify regulatory requirements early in the device development process.

The new program, called "Pre-Sub," is in response to a MDUFMA that increases fees in return for more meetings.

"FDA's early feedback on studies can facilitate the development of a quality premarket submission and help industry avoid regulatory hurdles during the review process," said Christy Foreman, director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health (CDRH).

The FDA is seeking public comment on the Pre-Sub draft guidance.

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A Little Guilding of the Eli Lilly

07/12/2012 07:02 AM |

Consider how Lilly’s social media presence grows.

Riding the success of its LillyPad blog and broader social media identity, Eli Lilly & Co. is branching out from the U.S. and Canada to Europe and south of the border in Mexico.

Lilly launched its LillyPad blog (http://lillypad.lilly.com) less than two years ago as a platform to discuss healthcare innovation and policy. On Twitter, the company tweets under the LillyPad handle about similar issues and has nearly 9,000 followers. Like most social media networkers in pharma, Lilly stays away from product-oriented issues and devotes attention to broader subjects in the healthcare realm.

With LillyPad branches in Europe and Mexico, the company can play by nation-specific rules and discuss off on the issues that are relevant to individual nations. Lilly also wants to give a tailored voice to specific business units. The company's clinical open innovation team, for example, has begun blogging and tweeting.

 Lilly’s emerging social media strategy appears to include establishing a wider presence in the global social media world while building targeted audiences based on factors such as geography and subject matter.  

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The Skinny About Obesity

07/11/2012 06:15 PM |

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Fizz Ed

07/11/2012 11:45 AM |

Obesity is largely a question of calories in and calories out.

So why is Mayor Bloomberg only concerned about the “calories in” part?

Is the Mayor’s focus on Big Gulp Disease a sleight of hand to divert attention from the city’s inability (or is it unwillingness) to address the “calories out” part of the equation?

In its biennial survey of high school students across the nation, the CDC reported in June that nearly half said they had no physical education classes in an average week. In New York City, that number was 20.5 percent, compared with 14.4 percent a decade earlier.

That echoed findings by New York City’s comptroller, in October, of inadequate physical education at each of the elementary schools that auditors visited.

New York City has not filed a physical education plan with the state since 1982, though state officials recommend a new one every seven years. A spokeswoman for the city schools says one will be presented in September.

It’s time for Mayor Bloomberg to step down from the bully pulpit long enough to get our kids back into the gym.

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Morning Joe

07/10/2012 08:16 AM |

Kudos to the behind-the-scenes work of the FDA and the industry’s Opioids Working Group (OWG).

The FDA has approved a final class-wide REMS for extended-release and long-acting opioids that requires companies to make educational programs available to prescribers at no or nominal cost. The REMS does not require prescribers to participate in the training programs, though FDA said it is working with Congress to explore legislation to mandate prescriber training, including a prescriber education requirement as a condition of obtaining registration with the Drug Enforcement Agency.

The required educational programs must cover the content of an FDA-developed blueprint, which includes the dangers of misuse and abuse, directions for patient selection and how to recognize evidence of misuse and abuse. FDA expects the first educational program will be offered by March 2013. Companies will be required to track the number of prescribers completing the program and whether the program is adversely affecting patient access to medications.

In other news, the President signed PDUFA. The law reauthorizes both PDUFA and MDUFA and creates new user fee programs for biosimilars and generics along with a slew of other important codicils.

Strange that the White House is silent on this important piece of bi-partisan legislation. As Veep Biden once said, "It's a big, f--king deal."

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In War Against Soft Drinks, Facts Are Hard For Critics To Swallow

07/09/2012 12:28 PM |

Did you know that a recent study found " that most children and youth who consume soft drinks and other sweetened beverages, such as fruit punch and lemonade, are not at any higher risk for obesity than their peers who drink healthy beverages."

Or that a long term study tracking low income children (The Bogalusa Heart Study) that started in 1973 found a "positive association between diet beverage consumption and overweight resulted from the consumption of diet beverages and non-sweetened beverages. "   

Probably not.   Like me, you were too busy fixating on the proposed ban on soft drink servings over 16 oz in NYC.  

The Bogalusa Heart Study team also concluded  "eating patterns were associated with overweight in young adults. However, the eating patterns explained only 1–2% of the variance in BMI. Thus, 97% of the variance is unexplained. More studies are needed to better understand how eating patterns in combination are associated with overweight before policy changes are made. Targeting single eating patterns in obesity intervention programs may not be the best approach. This is possibly reflected in the modest-to no-effect being observed with this approachIn this study, eating patterns were associated with overweight in young adults. "

So why are lobbying organizations and interest groups and the CDC and NYC attacking soft drinks if it is -- at best -- only a sliver of that 1-2 percent explaining BMI variance?   

In part it's because attacking the eating habits of the poor -- especially the rural and minority poor -- is fair game.   But the more important reason is the belief that obesity is the underlying cause of every chronic disease and the cost of health care.   So under the guise of controlling health care costs it is now becoming legitimate to have governments tell people what to eat and drink.    You would  never know that around the world, people are living longer and healthier lives, a trend that has boosted income and prosperity over the last half century.   

Worse, a campaign is under way to claim that sugar -- or drinking soda -- is as deadly to humans as tobacco is.    That's not science.  That's the sort of fear mongering that has made people afraid of vaccinating their kids.     Read More & Comment...

BHAG in Beirut

07/06/2012 08:56 AM |

Big Hairy Audacious Goals set doers apart from talkers.

Last week, “under the patronage of the Lebanese Ministry of Public Health,” I was honored to participate in the two-day “Drug Quality Forum” held at the American University of Beirut.

The focus of the event was on the impact of drug quality and safety with focused presentations on (among other topics) API quality, GMP requirements (as well as the often forgotten but hugely important GSDPs – Good Storage and Distribution Practices), data requirements and regulatory pathways. In attendance were senior health ministry officials from Lebanon, Syria, Jordan, and Iraq as well as representatives from the WHO and France’s Agence nationale de sécurité du médicament et des produits de santé  (ANSM) – née AFSSAPS.

Some brief verbatims:

David Holt (St. George’s University, London):  “There is nothing more expensive than clinical failure.”  He also cited the following from a recent paper in the British Journal of Pharmacology (2011;72:727-30)

“There are few prospective studies assessing potential additional risks associated with substitution and there are no established protocols by which switching is monitored or assessed.

This may make it difficult to know whether the money saved on the initial drug will still be saved as treatment outcomes on the substituted drug become apparent.”

Gilberto Lopes (The John’s Hopkins Singapore International Medical Center) pointed out that it’s not about the cost of pharmaceuticals but rather spending on pharmaceuticals – and that having more new therapies is a good thing.

Mark McGrath (Novartis) made the very important point that, “Quality cannot be implied.” This followed on my earlier comment that “Quality cannot be tested into a product. Quality is by design.”

At the end of the first day, Conference chairman, Dr. Joseph Simaan (Professor and Chairman, Department of Pharmacology and Toxicology, Faculty of Medicine, American University of Beirut), commented that public health officials are faced with “a moral dilemma” of wanting (and being under pressure) to approve locally manufactured generics – but cannot, in any way, allow sub-standard products onto the market.

As Khahil Gibran wrote, “Perplexity is the beginning of knowledge."

Day Two focused on topics ranging from bioavailability to bioequivalence and biowavers – highly technical presentations, but not without some humor. One example:

Q: Why were the two generic chemists so sad?

A: They were dissolutioned.

(Who said drug regulators don’t have fun?)

On that same topic, Soula Kyriacos (Pharmaline) gave a very informative talk on the correlation of product dissolution and bioavailability (in vitro vs. in vivo). And take my word for it – anything sounds riveting when presented by a smart woman speaking English with a Lebanese/French accent.

The last session of the meeting was devoted to developing a series of consensus recommendations for the attendees to take back to their respective nations within the GCC (Gulf Countries Cooperative). I was pleased to help moderate this effort along with Dr. Simaan, Dr. Ghassan Hamadeh (Associate Dean for CME, Faculty of Medicine, American University of Beirut) and Dr. Ziad Nassour (President of the Lebanese Order of Pharmacists).

Here are those recommendations:

1. Ministries of Health (MOH) to develop criteria for approval of bioequivalence centers (CROs) in compliance with International standards (GCP, GLP) in line with FDA, EMA, WHO or ANSM mechanisms for inspection and approval.

2. MOH to ensure that complete, detailed, and well-documented files are submitted for registration of all drugs according to ICH guidelines.

3. Any biosimilar application for an imported product must include a prior EMA or FDA approval

4. MOH must insist on emphasis of the quality of the active ingredient with full information on sourcing, materials and manufacturer.

5. Information leaflets of generic and innovator drugs should be up to date and made accessible and include all safety information.

6. No marketing approval for drugs without stability, and bioequivalence studies according to ICH guidelines.

7. No marketing approval for drugs not approved or marketed in their country of origin.

8. MOH to initiate product specific pharmacovigilance systems.

9. MOH to set up an efficient communication system to be used by Health Care Professionals and the Public to report safety issues with drug products

10. Drugs should not be sold in dispensaries. (Note: In Lebanon, “dispensaries” are supposed to provide generic medicines for those who cannot afford to buy them at no charge.)

11. Create a Department for Quality Control within the Ministry of health to review, authenticate submissions and inspect dossiers as well as track batches and perform random testing of marketed products.

12. Ensure all drugs are available through controlled supply chain.

13. Build capabilities in the ministry of health through enhanced training in

Big Hairy Audacious Goals? Absolutely.

That’s precisely what makes them so exciting.

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Adverse Event Horizon

07/05/2012 08:00 AM |

In a pithy commentary in Nature, Sir Alasdair Breckenridge, Chairman of the MHRA, (et al.) writes:

A life cycle approach to pharmaceutical regulation, in which the benefit–risk balance of new drugs continues to be robustly assessed following market approval, is emerging in both the United States and Europe.

Certainly.

But …

Whether the pharmaceutical industry joins in this consensus and whether companies will serve as willing or reluctant partners in an invigorated post-marketing drug regulation scheme remains unclear. Additional regulatory requirements are never welcome in the short term, and the post-marketing studies that may be required under the life cycle approach may impose substantial costs on manufacturers. However, industry has learned the hard way that inadequate responses to safety signals can have a serious detrimental impact not only on public health but also in economic and reputa­tional terms. The long-term interests of manufacturers and regulators in well-characterized benefit–risk pro­files are essentially the same.  

The complete article can be found here.

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The Name of the Rose

07/03/2012 07:26 AM |

What’s in a name? That which we call a rose by any other name would smell as sweet.

No doubt. But a name also is an aspiration.

It is with that preface that I am pleased to share a bit of news that arrived with my July Drug Information Journal – the publication (the official journal of the DIA) is changing its name.

Transparency Alert:  I am an Associate Editor of this journal.

The new title, Therapeutic Innovation & Regulatory Science, is a stake in the ground. First, it’s not just about “drugs.” That’s a great leap forward. Second, it’s about innovation. That’s where the action is. And third, it’s not about regulation, but rather “regulatory science.” That’s a global topic -- from the FDA’s Critical Path initiative to the EMA’s IMI and beyond. And, dare we hope – one that might some day lead to greater harmonization.

Like I said – a name is also aspirational.

Bon Courage, Therapeutic Innovation & Regulatory Science!

Our aspirations are our possibilities.

-- Samuel Johnson

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Adverse Event Generation Gap

07/02/2012 08:40 AM |

According to information presented at the American Society of Health-System Pharmacists Summer Meeting, health systems that rely primarily on voluntary reporting of adverse drug events identify as few as 6% of events." James M. Hoffman, PharmD, MS, BCPS, Medication Outcomes & Safety Officer, and Director, Medication-Use Safety Residency Program, and Associate Member in pharmaceutical sciences at St. Jude Children's Research Hospital in Memphis, TN, argued for using several different methods of detecting adverse events in order "to get a more complete understanding of opportunities to improve the medication use process … Underreporting is a key limitation of error reporting systems.” Hoffman proposed the use of four common methods: "incident reporting; direct observation; medical record review; and trigger tool." He also said that electronic health records can be "a key resource for event detection."

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