Amidst concerns raised by public interest advocates, the Food and Drug Administration is negotiating with drug industry representatives to increase controversial user fees, according to news reports.

User Fees to Expand, Include Advertising

In 1992, Congress authorized drug companies to pay user fees directly to FDA to help underwrite the cost of drug approvals. With congressional funding for FDA on the decline, the agency has become increasingly reliant on drug companies to fund the drug approval process. At minimum, this arrangement gives the appearance of a conflict of interest that can harm public trust in FDA approvals. Drug-approval scandals over the last few years, however, such as the highly publicized Vioxx scandal, have raised troubling concerns that the agency spends much more time and resources approving drugs than testing their safety.

Ongoing negotiations between FDA and the drug industry are expected to increase fees for drug approval. While fees would ensure FDA review all new drug applications within two-and-a-half months, some of the user fees would also fund post-market safety research. Moreover, FDA is considering expanding user fees to expedite approval of pharmaceutical advertisements. Under the proposal, drug companies would pay FDA $40,000 to $50,000 before each television ad campaign.

A tentative user fee agreement will be published in the Federal Register sometime in December, according to the BNA Daily Report for Executives (subscription only).

Critics Blast User Fee System

The Prescription Drug User Fee Act (PDUFA) must be reauthorized by Congress in 2007. During its last reauthorization in 2002, Ranking Member Henry Waxman (D-CA) strongly rebuked the agency for putting expedited approval above public safety and called for industry to pay user fees to ensure that drug ads were not misleading. "Speeding the review of new drugs is important. But ensuring the public that drugs are safe and effective demands more. We cannot sacrifice safety for speed. And we must be vigilant in our oversight of prescription drug ads to be sure that misleading ads do not prompt unsafe or inappropriate use of drugs." Waxman will chair the House Government Reform Committee when reauthorization occurs next year.

The Institute of Medicine released a report in September detailing necessary improvements to FDA's drug approval and safety programs. Along with recommendations to increase FDA's enforcement and oversight capabilities, IOM blasted the user fee system, saying that "[t]he Prescription Drug User Fee Act mechanism that accounts for over half of the Center for Drug Evaluation and Research's funding and the reporting requirements associated with the user-fee program are excessively oriented toward supporting speed of approval and insufficiently attentive to safety." IOM recommended Congress "introduce specific safety-related performance goals in the Prescription Drug User Fee Act IV in 2007." Moreover, IOM called for adequate funding of FDA, saying that over-reliance on user fees "hurts FDA's credibility and may affect [the] agency's effectiveness."