Regulatory Beat: FDA Moves to Renew User Fees and Promote Preparedness - Efforts to spur R&D and ensure drug safety will play a prominent role in negotiations to revise PDUFA. - BioPharm International


Regulatory Beat: FDA Moves to Renew User Fees and Promote Preparedness
Efforts to spur R&D and ensure drug safety will play a prominent role in negotiations to revise PDUFA.

BioPharm International
Volume 19, Issue 2


Lawton of BIO also suggested that one way to ensure drug safety is to improve FDA's evaluation of trade names. This may fit FDA's desire to make more user fee revenues available to support FDA postmarketing surveillance and risk management activities, which have been under intense scrutiny by Congress and the public in recent years. Under PDUFA 3, FDA can allocate user fee revenues for drug safety monitoring during the first two years a new drug is on the market (three years for potentially dangerous medications). However, the agreement covers only new drugs, not safety issues related to products approved five or ten years ago, such as COX-2 inhibitors or antidepressants.

More flexibility could provide resources for FDA to implement some of its recently proposed initiatives to increase product surveillance, improve its ability to communicate safety concerns to the public, and better organize its internal post-marketing oversight operation. However, pharma companies and health professionals have voiced reservations about some of these proposals. At a two-day meeting in December on FDA methods for communicating drug risk information, manufacturers, pharmacists, and other parties complained about the proliferation of agency "risk communication tools." In addition to labeling changes, FDA may announce safety concerns through press releases, talk papers, public health advisories, MedWatch safety updates, and information sheets for healthcare professionals and patients.

Manufacturers are particularly upset by FDA's new plan to post "emerging" drug safety information on a new Drug Watch website. Industry representatives fear that such actions would confuse both consumers and physicians about whether a drug is unsafe and should no longer be prescribed. Agency officials now say they will "go back and rethink" the Drug Watch Plan, but some type of early-safety-warning system is likely.


At the PDUFA meeting, Jesse Goodman, director of the Center for Biologics Evaluation and Research, noted that user fees don't cover CBER oversight of tissues, blood banks, or public health and safety assignments. At the same time, CBER is charged with spurring access to new vaccines and countermeasures to protect the nation against looming epidemics and bioterrorism threats. The Bush administration unveiled a $7.1 billion Pandemic Influenza Plan in November 2005 that includes a $2.8 billion "crash program" to revitalize vaccine manufacturing in the US. One aim is to support a shift from egg-based flu vaccine production to advanced cell-culture approaches able to produce new flu vaccines in six months. Another $1.5 billion would buy 40 million vaccine doses by 2009; $1 billion would stockpile enough antivirals to treat 25% of the population.

Congress approved a down payment on the program in December by adding $3.8 billion for pandemic preparedness to the $453 billion 2006 defense appropriations bill. The legislation does provide $20 million to support FDA research and oversight of vaccine production, but this is a relatively paltry amount that will barely cover the cost of monitoring vaccine manufacturing facilities in the US and abroad. The 2004 flu vaccine crisis required FDA officials to spend weeks overseeing vaccine quality and inspecting manufacturing sites, while also engineering accelerated approval for new sources of supply.

The most controversial provision in the defense funding bill – and one of critical importance for industry – provides liability protection for manufacturers of pandemic countermeasures. Democrats attacked the measure as excessively broad, even though manufacturers did not get all that they wanted. BIO termed the bill "balanced" and important for rebuilding the nation's vaccine infrastructure, despite its failure to provide additional patent incentives for new product development. Strong opposition from generics makers blocked adoption of a controversial "wild card" exclusivity provision that would have granted patent extensions on commercial products in exchange for producing low-profit countermeasures.

An FDA Rapid Response Team will coordinate agency pandemic preparedness activities with industry and other public health agencies. One task is to detect and manage production problems that could block adequate supplies of antivirals and vaccines. Among other responsibilities, the team can authorize other firms to manufacture a patented product for emergency use. All these activities will further stress FDA's resources, especially if a public health crisis does appear.

Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634,

blog comments powered by Disqus



GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines
Source: BioPharm International,
Click here