US could overhaul drug test/approval process

A biparisan proposal to overhaul the drug testing and approval process in the USA has been agreed by the US Senate's Health, Education, Labor and Pensions Committee Chairman, Senator Michael Enzi (Republican, Wyoming) and Senator Edward Kennedy (Democrat, Massachusetts) the senior Democrat committee member. Details have not been released at the time of writing, although the New York Times published some points on June 21.

A spokesperson for the US Food and Drug Administration, which would be expected to implement many of the likely proposals of the draft bill, said that the agency had not seen a copy of the plan, but said: "we always welcome additional ideas on improving oversight of drug safety."

In preparing for the draft legislation, congressional staff have contacted representatives of the drug industry and scientists, as well as taking political soundings from colleagues about the political feasibility of any legislation. Among the ideas apparently under discussion: the results of all major human drug trials in Phases III and IV to be made public; a risk management plan would have to be created to "uncover and control any safety problems that arise" after a drug is approved; and the imposition of fines for failure to follow through with such a plan.