The latest round of Senate hearings to consider reforms to the US Food and Drug Administration saw the agency’s acting deputy commissioner, Janet Woodcock, come out fighting in its defence, saying that the agency does not require any new authority from Congress to ensure prescription drug safety.
In her testimony to the Senate Health, Education, Labour and Pensions Committee, Ms Woodcock said the FDA’s “review process is recognised worldwide as a gold standard.” However, she added: “No amount of study before marketing will ever elucidate all the information about effectiveness or all the risks of a new drug, therefore, post-marketing surveillance is extremely important.” Ms Woodcock explained that measures are already in place to deal with drug safety – as shown by the recent advisory panel meeting, which looked at the current marketing and safety issue concerns over certain COX-2 inhibitor drugs [[21/02/05a]]. She also noted that plans to establish an independent drug safety oversight board show the agency is responding to the public’s desire for more openness and a body outside the FDA would not improve the situation [[16/02/05a]].
Nevertheless, a number of high-profile withdrawals of drugs – the latest being Biogen Idec and Elan’s multiple sclerosis drug. Tysabri (natalizumab) [[01/03/05a]] – has only added to calls for change. Speaking at the hearing, Raymond Woosley of the University of Arizona, testified that the practices the FDA uses to monitor the safety of drugs fail to “detect serious adverse effects of products until they are on the market, often for years, and millions of Americans have been exposed to potential harm.” He added that the FDA should be given the authority to release medicines “in stages that are appropriate for the drugs’ level of development and the information that is known at the time,” with studies to continue after approval of treatments.
The final word, for the time being, went to republican senator, Michael Enzi, the HELP committee chairman, who said the FDA’s internal reforms don’t go far enough to protect patients. He stated that he would explore options with democratic counterpart, senator Edward Kennedy, in seeking a response acceptable to “both sides of the aisle,” but also cautioned that “we should not try to reinvent the wheel and develop a system that aims for an impossible standard of zero risk.”