A Sheep in Wolfe's Clothing

  • by: |
  • 08/15/2014

In an outrageous commentary in the British Medical Journal, Sid Wolfe cites a JAMA study that claims “new black-box warnings and safety withdrawals have increased following PDUFA’s enactment, perhaps as a result of an expedited review process that may not adequately detect serious drug safety problems in the preapproval period.”

Statistics, the saying goes, are like a bikini. What they show you is interesting, but what they conceal is essential. In the case of Dr. Wolfe, it’s a case (in fact, the latest in a series) of taking evidence and selectively using it to prove a long-held theory. In the case of Sid Wolfe, the theory is that PDUFA puts FDA in industry’s pocket. Nothing could be further from the truth.

Much has changed since the introduction of user fees in 1992 and one of the most important changes has been in the medical innovation. Since 1992 both small and large molecules have become more complex. Since 1992 these new medicines have addressed the unmet medical needs of many orphan and serious chronic diseases.

But new drugs are more than about just reward. Many of these new FDA-approved medicines have a higher risk profile. And with better data management tools, the FDA is now able to capture adverse event information in a more timely and accurate manner. This is especially important when it comes to the approval of medicines with a higher risk profile. Post-marketing pharmacovigilance, whether in the form of more targeted REMS or more sophisticated surveillance techniques allows the FDA to pursue expedited approval pathways for those medicines it feels fill a void in the therapeutic armamentarium. The voice of patients supports this approach, as does that or practitioners. And it also supports innovation.

As Paul J. Seligman, former chief of post-marketing drug surveillance at the FDA, commented back in 2005, it’s important to “develop the science for monitoring adverse events in ways that will allow us to give adequate warnings.”

No pharmaceutical company wants its product brought to market more swiftly if that will lead to a rapid recall. The fact that there are more products with boxed warnings is a direct consequence of the FDA’s efforts to better inform physicians and patients to the risk/reward ratio of these new products. It’s 21st century safe use or, as the French refer to it, bon usage. In that respect, more product withdrawals are the natural consequence of better pharmacoviiglance – the counterweight to expedited approvals of higher risk medicines.

And nothing to do with PDUFA fees.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog