The Prescription Drug User Fee

Wednesday, September 20, 2006

The Prescription Drug User Fee (User Fee) isn’t a fee that consumers pay directly. It’s a “user fee” the drug corporations pay the Food and Drug Administration (FDA), in exchange for quicker approval of their new drugs. The fee is steep—drug companies pay about $800,000 to get their drugs approved faster. Consumers wind up paying later, in the form of health risks and overpriced medicine. Read more about the The Prescription Drug User Fee.

These fees, codified in the Prescription Drug User Fee Act (PDUFA), effectively put the FDA on the payroll of the pharmaceutical industry. More than half of FDA budget for drug reviews now comes from drug companies—this is a conflict of interest. If you had to hand a book reviewer a bag of money in order to get your publication reviewed, she might still give it a fair, impartial critique. Or she might be tempted to give you what you paid for, and overlook the flaws.

In the late 1990s, the FDA gave “priority” reviews to Celebrex and Vioxx, even though they had not shown better pain relief than existing over-the-counter drugs like Advil. The conflict of interest was painfully clear when the FDA ignored four years' of data indicating that Vioxx users were four times as likely to have heart attacks. By one estimate, this delay led to the deaths of 55,000 Americans.

Since the FDA User Fee took effect in the early 1990s, FDA employee performance evaluations are based largely on how many drugs get approved. More approvals are seen as better results. If a FDA User Fee deadline is missed, the FDA looks bad.

The FDA has become a “captured agency”—a once independent regulatory body that through money and influence has come to serve industry interests rather than those of the American public. Dr. David Graham, an FDA senior drug safety official, was told by his superiors that the “industry is our client.” It’s tough to argue with Dr. Graham when the FDA allows people who stand to gain financially from a drug’s approval to sit on FDA drug safety panels. Read: 10 on FDA Vioxx panel had ties to companies.

In July 2006, a study by the Union of Concerned Scientists found that 20% of FDA scientists had been told by FDA management to lie to the American public. Forty percent said they couldn’t voice concerns about drugs “without fear of retaliation.” [Read more.]

The Prescription Drug User Fee Act must be reapproved every 5 years—the next vote is in 2007. (Last time, renewal was tacked on to a bioterrorism pork barrel bill.) You can help drive this change by urging your lawmakers to support the FDA Improvement Act, which would sever the financial ties between drug corporations and the agency. The legislation would require any fees to be paid to the Treasury, which in turn would fund the FDA. This legislation has the potential to eliminate people who stand to profit from appointments to FDA advisory committees.

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