Power to the FDA

There is at least one forum every year where biopharmaceutical executives can pose questions directly to the management of the US Food and Drug Administration’s Center for Drug Evaluation and Research. This is the ‘CDER Town Meeting’ at the annual meeting of the Drug Information Association (DIA).

This year the hot topic was drug safety. Nearly everyone at the June 2008 meeting in Boston, Massachusetts was eager to find out how the FDA planned to use new powers on drug safety which were granted to it under the Food and Drug Administration Amendments Act of 2007. Signed into law in September 2007, the FDAAA gives the agency the authority to require companies to conduct post-marketing studies, prepare risk-management plans for drugs that pose unusual safety problems and to swiftly implement boxed warnings with new safety information. Previously the agency could ask companies to undertake corrective measures if safety problems arose, but it could not fall back on statutory powers to enforce these instructions.

Conference delegates were eager to find out how the FDAAA had changed the work practices and priorities at the agency.

John Jenkins, director of the Office of New Drugs, said the legislation was being implemented gradually. It is a complex law with many provisions. But there was no question that it empowered the FDA to act swiftly and decisively whenever it identified new problems. He cited product labelling as an example.

In the past, if the FDA spotted a safety problem, it could ask companies to add a boxed warning to their product labels. It would then monitor compliance. In cases where a group of drugs required a boxed warning, it would discuss the label changes with the manufacturers on a case-by-case basis. Under the new legislation, the agency will be able to require companies to make these changes immediately.

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