US House Accord On FDA Drug Review Legislation "Near"

Agreement in the US House of Representatives on legislation to streamline Food and Drug Administration review of drugs could be near, says Representative James Greenwood, but there are still major barriers to revamping the approval process for food.

Rep Greenwood plans to introduce compromise language on three bills changing the review process for new drugs and biotechnology products, foods and devices. After a four-hour meeting with FDA Commissioner David Kessler, he said he was satisfied that a compromise is within reach on drug review. But, he told the National Health Council, work remains on revamping the review process for foods and medical devices.

A spokeswoman for Rep Greenwood told the Marketletter that the target for introduction of the compromise language was the end of June (after the Marketletter went to press), but it was unclear if that target would be met. Since negotiations were continuing, she was unable to give any details of the new language.