Senate HELP Committee To Consider Prescription Drug Safety Bill

The Senate Health, Education, Labor and Pensions Committee on Thursday will consider drug safety legislation by committee Chair Michael Enzi (R-Wyo.) and incoming Chair Edward Kennedy (D-Mass.), the Boston Globe reports (Henderson, Boston Globe, 11/16). The bill would require pharmaceutical companies to agree with FDA on a “Risk Evaluation and Management Strategy,” which for three years would include an annual review of new medications. Under the provision, pharmaceutical companies would have to file with FDA 15-day, quarterly and annual reports on adverse events related to new medications, as well as a plan “to assess known serious risks and to identify unexpected serious risks.” REMS also could require post-market, or Phase IV, clinical trials and could include restrictions on direct-to-consumer advertisements for new medications. In addition, the legislation would establish a Drug Safety Oversight Board to mediate disputes between FDA and pharmaceutical companies over REMS. The bill would establish the Reagan-Udall Institute for Applied Biomedical Research — funded initially by the federal government and later by a combination of federal, industry and philanthropic funds — to consider proposals to reduce the time required to assess the safety of new medications. The legislation also would require pharmaceutical companies to post the results of Phase III and Phase IV clinical trials in a public database (Kaiser Daily Health Policy Report, 8/4). The hearing on Thursday will include testimony from the Institute of Medicine, which released a report earlier this year criticizing FDA’s drug-safety monitoring policies. FDA Oversight
The hearing gives “Democrats their first post-election opportunity to say how they will strengthen the FDA when they become the majority party in Congress,” the Globe reports. Kennedy on Wednesday said, “Science has, too often, had to take a back seat at the very agency which should be setting the standard for objectivity and integrity.” Kennedy added, “There is also growing evidence that the dedicated professionals at the FDA have been pressured to trim their scientific views to the prevailing political winds. These are symptoms of a serious illness, and we should act without delay to provide the cure.” Kennedy has planned a series of FDA oversight hearings for early 2007 (Boston Globe, 11/16). In addition, The Hill reports that “the new Democratic majority has an obvious legislative vehicle to use to advance its plans for the FDA” — the Prescription Drug User Fee Act, which expires at the end of 2007. “Some Democrats and consumer groups have argued that the user-fee program has made the FDA too dependent on — and too cozy with — the [pharmaceutical] industry,” The Hill reports. At least one House Democrat plans to propose that user fees from drug companies go to general government revenues rather than directly to FDA. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, on Wednesday suggested that the agency seek higher user fees in order to improve safety monitoring of drugs on the market. Gottlieb added that drug safety issues “are likely to be front and center when the new Congress convenes next year” (Young, The Hill, 11/16).

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