Legislation introduced to create a new drug safety office at the FDABMJ 2005; 330 doi: http://dx.doi.org/10.1136/bmj.330.7499.1044-f (Published 05 May 2005) Cite this as: BMJ 2005;330:1044
After a year of controversy at the US Food and Drug Administration over drug safety, Senators Chuck Grassley (Republican, Iowa) and Chris Dodd (Democrat, Connecticut), introduced legislation last week to establish an independent office of drug safety at the agency.
The Food and Drug Administration Safety Act of 2005, if passed, will establish a Center for Post-market Drug Evaluation and Research. Its director would report directly to the FDA commissioner. Currently, the FDA's Office of Drug Safety serves in a consultative role to the Office of New Drugs.
David Graham, the FDA scientist who testified before a Senate committee about FDA's mishandling of drug safety last November, told the BMJ, “This legislation is long overdue. I'm pleased that Congress will address this important issue that affects the public health.”
Under the new FDA Safety Act, the director of the Center for Post-market Drug Evaluation and Research would have broad authority to require manufacturers to do post-marketing clinical trials to ensure drug safety.
This provision of the act is important, said Peter Lurie, deputy director of Public Citizen's Health Research Group in Washington, DC, because “historically, [the] FDA hasn't had the power to require a study after approval, unless it does so at the point of approval.” A 1999 study by Public Citizen found that manufacturers completed requested post-marketing trials for only 13% (11/88) of new molecular entities within 5 to 10 years after drug approval. The act also empowers the new safety office secretary to levy fines of up to $2m (£1m; €1.5m) for each 30 day period that manufacturers fail to complete studies.
Dr Lurie said the act would offer “intermediate” choices to the FDA that do not currently exist. “The problem the FDA has in respect to post-marketing studies is that they have too little power and too much power. Too much, in that, the only thing they can do [if they see a problem] is to yank a drug. Frankly, that's an action that's too strong in some instances. You don't want to be in a situation where a drug might offer benefit for some people and you can't require further studies or intermediate sanctions—and this legislation provides that intermediate choice.”.
Congressman Maurice Hinchey, (Democrat, New York), told the BMJ, “I applaud Senators Grassley and Dodd for taking the initiative to improve drug safety. I do believe that more needs to be done to change the culture at the FDA. For far too long the FDA has treated the pharmaceutical industry as a 'client' rather than as a regulated industry. Next week I will be introducing an FDA reform bill that will end the 'cosy relationship,' between the drug industry and the FDA, establish an independent Center for Post-Market Drug Regulation, and empower the FDA with broad new legal authority over the drug industry.”.