OBSERVERS SKEPTICAL OF DELAURO POSTMARKET FAILURE CLAIMS
Rep. Rosa DeLauro (D-Conn.), a frequent critic of the FDA's drug safety system, has seized on a recent agency report as evidence that the agency's postmarketing efforts are failing, but industry and activists are skeptical of her reasoning.
The agency released a report Feb. 1 on drug and biologics companies' performance in conducting postmarketing studies, which are used to determine a product's safety and efficacy. The report found that 71 percent of all companies' postmarketing commitments were "pending" a year after their products were approved.
The failure of companies to finish these studies within a year "shows that the FDA needs to reassess its commitment to improving drug safety," DeLauro said in a release. Companies are also to blame, she said. "This report clearly demonstrates that drug companies do not intend to keep these promises, and that drug companies are taking advantage of FDA's lack of authority to require these studies."
DeLauro's statements come as the push for new drug safety authority begins to heat up in Congress, with lawmakers introducing competing drug safety bills late last week. The FDA also recently released its plan for improving the agency's handling of drug safety problems.
But industry officials and even some activists are skeptical of DeLauro's use of the report. Many times it takes more than a year to establish the clinical trials necessary to assess a drug, sources with PhRMA and the Biotechnology Industry Organization said. Developing the clinical protocol and recruiting patients to participate takes two years, on average, Scott Lassman, PhRMA's senior assistant general counsel, said.
The report is available at www.fda.gov/OHRMS/DOCKETS/98fr/E7-1749.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-1749.pdf).