User Fees, Drug Safety - Pharmaceutical Technology

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User Fees, Drug Safety
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Before talking about more fees, Abbott Senior Vice-President Bruce Burlington, representing Pharmaceutical Research and Manufacturers of America (PhRMA, Washington DC, at the November meeting, urged further analysis of whether current user-fee revenues are wisely spent. Burlington noted that an FDA study of first-cycle application reviews and a fresh look at the effect of risk management plans would be informative. Industry supports further development of FDA computer information systems, as well as a suggestion from the Biotechnology Industry Organization (BIO, Washington DC, to improve drug safety through better evaluation of product trade names.

A common goal for FDA and industry is to link any increases in user fees to a rise in federal appropriations for the agency. This past year, pharmaceutical and biotech companies paid ~$250 million in fees for applications, products, and facilities, exceeding by nearly $50 million the portion of appropriated funds devoted to drug-review activities. This situation undermines the complex trigger arrangement established in 1992 to ensure that user fees would be additive to FDA appropriations and not merely replace public funding, a deal backed by all parties. Although the numbers-crunchers have provided FDA with enough appropriated funds to trigger user-fee collections each year, the continued squeeze on FDA's budget challenges the program's basic principle.

One source of added revenue could come from user fees on generic drugs. This long-discussed proposal resurfaced in recent months, as prospects have dimmed for budget increases earmarked for FDA's Office of Generic Drugs. Generics makers say they're willing to discuss the idea, but application fees for abbreviated NDAs (ANDAs) are tricky because of often lengthy delays between when FDA approves an ANDA and when the product comes to market.

Supporting safety

One FDA request is to make additional user-fee revenues available to support drug safety initiatives. The aim is to improve FDA's drug safety surveillance system and risk management activities that have been under intense scrutiny by Congress and the public for the past two years.

A relatively small portion of fee revenues was allotted for postapproval surveillance under PDUFA 3, but drug safety and risk management have become more prominent challenges for the agency. In the past decade, FDA has experienced a huge growth in the number of adverse event reports it receives, a trend that reflects rising prescription drug use overall. Galson pointed out that CDER staff actually devotes 50% of its time to drug safety activities, a figure that includes the assessment of safety studies in NDAs and scrutiny of manufacturing product quality by reviewers and plant inspectors.

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 mediations)—and not safety issues related to products approved five or 10 years ago. More flexibility would provide resources for FDA to implement some of its recently proposed initiatives to expand surveillance, improve its ability to communicate safety concerns to the public, and better organize its internal postmarketing oversight operation.

Manufacturers and healthcare professionals have raised concerns about some of FDA's new safety initiatives, however, and these objections may be addressed as part of the PDUFA 3 negotiations. At a two-day meeting in December about FDA methods for communicating drug risk information, manufacturers, pharmacists, and other parties complained about the proliferation of risk communication tools that include FDA press releases, talk papers, public health advisories, MedWatch safety updates, and patient safety news reports in addition to labeling changes. FDA recently added patient information sheets and healthcare professional information sheets to the arsenal.

Manufacturers are particularly upset by FDA's plan to post emerging drug safety information on a new Drug Watch Web site. Industry representatives described the plan to make early adverse event signals publicly available as likely to confuse both consumers and physicians about whether a drug is unsafe and no longer should be prescribed. In response, agency officials plan to go back and rethink the proposal, according to Galson of CDER, who recently termed the Drug Watch proposal "one of the most challenging policy issues" before the agency.


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