A senior US politician is to file a bill to allow the formation of an independent office to monitor the safety of medicines on the market, claiming that the country’s Food and Drug Administration has become “too complacent” about safety and “too cosy” with drug companies.
Chuck Grassley, chairman of the Senate Finance Committee, told a Consumer Federation of America meeting last week that he is drafting legislation to create the office in the interests of public health, in the wake of high-profile drug safety cases such as Merck & Co’s withdrawal of the painkiller Vioxx (rofecoxib) [[01/10/04a]], and plans to file the amendment in the next few days.
The FDA is under fire for what is alleged to be a failure to properly ensure prescription drug safety. Just last week, acting deputy commissioner, Janet Woodcock was forced to defend the agency in front of the Senate Health, Education, Labour and Pensions Committee – which has direct jurisdiction over FDA – on its regulatory record [[07/03/05b]]. The FDA and the US Administration want to tackle the issue with a series of internal reforms such as the creation of an internal Drug Safety Oversight Board, proposed by acting FDA commissioner Lester Crawford in mid-February [[16/02/05a]], and a strengthening of the adverse event reporting system for drugs.
But, according to the Los Angeles Times, Grassley, who is collaborating with Senator Christopher Dodd, a member of the HELP Committee, believes it is essential to have an independent office to tackle the issue. This would have the legal authority to require drug makers to alter prescribing information. Earlier this month, the deputy director of the FDA’s Office of New Drugs, Sandra Kweder, acknowledged that the agency needed more power to force labelling changes for drugs that appear to be unsafe [[02/03/05c]]. The new office could also have the power to ban direct-to-consumer ads. “If you want accountability, it doesn’t make sense to have the office that reviews the safety of drugs to be under the thumb of the office that puts the drug on the market in the first place,” Grassley told the newspaper.
Although the Finance Committee has no power over the FDA, Grassley has “hinted he may use his committee’s jurisdiction over Medicare and Medicaid to force changes,” the LA Times reported.
