Following a week of sometimes fraught negotiations, the US Senate has overwhelmingly approved a bill which is designed to increase the authority of the Food and Drug Administration and is being seen as a victory for ‘big pharma’.
The Food and Drug Administration Revitalization Act (S 1082), which re-authorises the Prescription Drug User Fee Act, was passed by 93 votes to one. Its underlying purpose is to renew, up to 2012, the PDUFA programme that sees drugmakers pay annual fees of around $400 million to the FDA to defray the cost of reviewing new medicines but the bill also deals with much larger issues of safety.
The bill gives the FDA the power to demand that pharmaceutical firms carry out post-marketing studies and authority to change label warnings without first having to negotiate with the drugmakers as is presently the case. The agency will have to establish a database to track adverse events for marketed drugs and can insist that a manufacturer adopt a “risk evaluation and mitigation strategy” for a treatment that poses serious risks.
However, the Senate replaced a measure in the legislation that would have allowed the FDA to temporarily ban some advertising for prescription drugs with fines for pharmaceutical companies that produce misleading adverts.
The driving force behind the bill was a perceived need to address the American public’s loss of confidence in the ability of the FDA. to protect it against the dangers implicit in taking certain drugs, highlighted by the furore that surrounded Merck & Co’s COX-2 inhibitor Vioxx (rofecoxib) and its subsequent withdrawal from the market in 2004.
Democrat Senator Edward Kennedy, who co-sponsored S 1082, with Republican Senator Mike Enzi, said the bill “will make a major difference for families in America, ensuring the safety of our prescription drug system,” adding that “this landmark legislation creates a stronger FDA and sets forth a new and better direction for the safety of the drugs we take”. Explaining the need for a more powerful agency, he noted that “for Vioxx, it took 14 months to change the drug’s label, to warn doctors and patients of the danger. Companies routinely promise to conduct studies that are never even started, much less completed.”
Sen Enzi was equally euphoric, saying that the bill, which will now go to the House of Representatives, involved the “most comprehensive drug safety overhaul in more than a decade.” He added that “today, we have risen above partisan politics to deliver a monumental victory for all Americans.”
Does S 1082 go far enough?
However a number of groups do not share the two senators enthusiasm and are critical about what the bill does not cover. Many were disappointed that Democrat Senator Byron Dorgan’s proposal to allow the importation of medicines, which would reduce their prices in the USA was watered down to only requiring the Department of Health and Human Services to affirm the safety of drugs from abroad.
Also, the bill does not touch the controversial issue as to whether a pathway should be established at the FDA for the routine approval of generic versions of biologic drugs. These two issues were seen as stumbling blocks to the bill passing and would have led to a veto from the Bush Administration.
Sidney Wolfe, director of Public Citizen's Health Research Group, said the bill will not improve patient safety, claiming that it failed to address charges that the FDA routinely ignored the advice of scientists over safety issues. In an interview with health care information portal WebMD, he criticised the PDUFA concept, saying that “if anyone thinks [the fees] do not alter FDA's vigilance over the industry, they're just delusional. Anyone who thinks this is going to slow or halt the seemingly endless series of drug disasters is really wrong."|