Expansion of FDA Drug Safety System

Separately, the FDA is proposing assessing drug companies a fee to review direct-to-consumer television advertisements before they air. The FDA currently has only a limited ability to curb distribution of drug ads that violate federal rules, according to a recent report by government auditors. The FDA expects to collect about $6 million in such fees, which would underwrite the salaries of 27 extra employees to review the TV ads. However, drug companies still would not be required to submit their ads for review.

The recommendations also include a pilot program that would leave it to drug companies to assess the appropriateness of any proposed names for new drugs — a task now performed by the FDA. Look- and sound-alike drug names can lead to medication errors, the FDA said.

The FDA also would spend nearly $5 million in new fees on developing guidelines for industry that can help expedite the development of new drugs and almost $12 million to defray the cost of moving workers to the FDA’s new consolidated campus in Maryland, according to the proposal.

Since its recall of the drug Vioxx in September of 2004, the FDA continued to receive intense criticism from Congress on its ability to track the safety of new drugs. A draft proposal was released today by the Food and Drug Administration which would raise fees pharmaceutical companies pay the FDA for performing safety reviews. The proposed increase would raise the fees 29 percent, up to $393 billion.

Since it was enacted in 1992, the Prescription Drug User Fee Act, or PDUFA, has authorized the FDA to collect fees from drug companies to underwrite the cost of reviewing their products. The law, which has twice been extended for five years, expires Sept. 30 unless renewed by Congress. Lawmakers expected to use the reauthorization as a vehicle for legislation to further reform the FDA.

Please see, PDUFA Fact Sheet and article from Los Angeles Times for more information.