in PDUFA veritas

  • by: |
  • 08/27/2007
Drug Industry Daily
Aug. 27, 2007 | Vol. 6 No. 168

PDUFA Provisions Could Harm FDA and Industry, Expert Say

Some of the provisions in the FDA Revitalization Act, S. 1082 and H.R. 2900, would be ineffective, could cripple the FDA and would put unnecessary burdens on pharmaceutical companies, Center for Medicine in the Public Interest President Peter Pitts said at the Third Annual FDA Regulatory and Compliance Symposium at Harvard University. “Political battles are trumping public health,” he added.

The most important part of the bill is a provision funding the Reagan-Udall Institute and the agency’s Critical Path Initiative, according to Pitts. “This is the single most important advance and change in FDA legislation, possibly ever,” he said. “It really sets the FDA on the path to a 21st century perspective in terms of both protecting the public health and advancing the public health.”

The FDA’s recent label change for Coumadin (warfarin) to add information about genetic tests was “such an important advance,” Pitts said, adding that the agency should continue doing more with the Critical Path Initiative (DID, Aug. 17).

However, Pitts said some provisions in the legislation will be ineffective and could harm the FDA. He criticized a provision that would ban members with more than $50,000 in financial conflicts of interest from voting on advisory committees. The FDA recently issued a draft guidance of a proposed rule that would do the same thing (DID, March 22).

“All this will succeed in doing is allow the agency to recruit the second best and the almost brightest for advisory committees, and that is not acceptable,” Pitts said. He added that $50,000 is an arbitrary limit.

Pitts also criticized the bill’s Risk Evaluation and Mitigation Strategies (REMS) requirements. He noted that early drafts of the bill contained language that would have made it mandatory for each new drug application to contain an REMS. “That’s like saying every new product is equally risky,” Pitts said.

Giving the FDA the authority to require an REMS as part of a new drug application could encourage the agency to call for them more, even when they are unnecessary, he said.

However, the enhanced focus on safety and postmarketing surveillance is the industry’s fault for not living up to its commitments to conduct postmarketing studies, Pitts said. “Now they are reaping what they sowed,” he added. Companies should use the opportunity to conduct postmarketing studies for public health purposes, he said.

Pitts also criticized the provisions in the bill that would add a user fee for a voluntary review of direct-to-consumer advertisements. The FDA’s Division of Drug Marketing, Advertising and Communications has no predictability and will send companies warning letters even if they incorporated all of the agency’s suggestions in their advertisements, according to Pitts. “If the FDA wants to have an impact in quality and safety and appropriateness, they can’t change their minds after the fact, fee or no fee.” — Emily Ethridge

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
Better Health
Biotech Blog
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
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
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
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog