Drug companies fail to conduct necessary post-marketing studies

Most of the studies that U.S. federal health officials require drug companies to perform on new medicines after they hit the market are never done, a US consumer group charged on Thursday.

Often when the Food and Drug Administration (FDA) approves a drug, it orders the manufacturer to conduct further studies of side effects or how well it works for certain patients. But only 13% of the 88 follow-up studies required for drugs launched in the early 1990s were completed, according to a report by consumer group Public Citizen.

No studies were finished for 107 drugs that went on the market between January 1995 and last December, the group said. An FDA official said that the figures, from agency records that Public Citizen obtained through the Freedom of Information Act, were incomplete. She said that the agency was working to gather exact numbers and make them public.

A trade association representing drug companies disputed Public Citizen’s findings. ‘The industry is meeting all of its FDA commitments,’ said Jackie Cottrell, a spokeswoman for the Pharmaceutical Research and Manufacturers of America. But Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group, said that the apparent neglect of the studies might mean that side effects go undetected. The FDA monitors drug reactions but its system has limitations and would benefit from added information, he said.

The report ‘paints a grim, dangerous picture,’ Wolfe wrote in a letter to FDA Commissioner Jane Henney. ‘Pharmaceutical companies are systematically failing to fulfil their commitments to the FDA.’

Dr. Lisa Rarick, deputy director of one of the FDA’s five drug evaluation centres, said that all drugs reviewed were safe when used according to the instructions on their labels, even in cases where the agency had asked for additional studies. ‘We believe at the time of our approvals that we have enough information to appropriately label it,’ Rarick said in an interview. ‘A lot of times we want to be able to improve the label’ using new information.

The FDA’s drug review process came under scrutiny after manufacturers agreed last month to stop marketing two drugs, Warner-Lambert Co.’s Rezulin (troglitazone) for diabetes and Johnson and Johnson’s Propulsid (cisapride) for heartburn.

Wolfe said that the FDA should ask Congress for authority to impose large civil fines on companies that do not complete their required studies