SUPPORT FOR SAFETY
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.
PROTECTING AGAINST PANDEMICS
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, jwechsler@advanstar.com
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