DELAURO SETS SIGHTS ON INCREASED DRUG SAFETY OVERSIGHT
Rep. Rosa DeLauro (D-Conn.), the incoming chairwoman of the subcommittee with jurisdiction over the FDA's budget, has a number of changes in mind for the agency, starting with an improved drug review system, the lawmaker says.
In a Jan. 19 briefing, DeLauro said she believes the FDA has devolved into an agency that values politics over science, calling that her "biggest concern." The agency needs numerous changes and the congresswoman said she plans to use the appropriations clout and oversight authority of her committee to drive these improvements.
Congress needs to "make sure that the efforts we are funding are working for the public good," she said. To ensure that, DeLauro is planning a marked increase, beginning this summer, in the amount of congressional oversight, compared with when Republicans ran the House. "I believe that over the past several years, the Congress has abdicated its responsibility for oversight," she said.
Overall, DeLauro's priorities include: improving the FDA's handling of postmarket drug safety reviews; direct-to-consumer advertising; sufficient funding for generic drug reviews; addressing the agency's advisory committee conflict-of-interest policies; improving device oversight; handling drug importation; and renewal of agency user fees.
While DeLauro said she will work on all of these issues, she considers drug safety a "critical" area. "Drug safety is life and death" in some cases, she added.
DeLauro's staff will study the recent Institute of Medicine (IOM) report on drug safety. The IOM recommended that Congress give the FDA the authority to require whatever postmarketing risk assessment and risk management programs are needed to monitor and ensure the safe use of drug products.
She is also planning to speak with former FDA staff about the pressures they've faced from superiors regarding drug reviews.