Advisory Panel Rejects FDA Proposal: Good Idea, But Wrong Approach
In late October 2005 an FDA advisory panel rejected the agency's recent proposal that would have required the drug companies to do longer-term studies before any new psychiatric drug could be brought to market in the U.S.
The FDA had convened this advisory panel to discuss the agency's proposal whereby before a new psychiatric drug would be approved for use in the U.S. the drug companies would be required to submit "longer-term efficacy data". The FDA proposal covered any new prescription drugs that are intended to treat:
- bipolar disorder;
- schizophrenia; and,
- a range of other psychiatric illnesses.
Rather than voting on the entire proposal, however, the FDA advisory panel stopped after voting (12-0) against one part of the proposal that would have required long-term efficacy data for new psychiatric drugs intended to treat major depressive disorder, the first category listed above. The panel decided to not vote on whether the proposal should be applied to the several other psychiatric disorders categories listed above. Instead, the advisory panel said the FDA should consider each psychiatric disorder separately -- as the panel itself did with its lone vote concerning the depression category -- as opposed to the FDA arguably pushing a "one-size-fits-all" approach, i.e., covering all the new psychiatric drugs.
As expected, the pharmaceutical industry argued against any proposal requiring long-term efficacy studies before a drug is approved. Essentially, representatives from several drug companies, including Merck & Co., Pfizer Inc. and GlaxoSmithKline PLC, argued that the FDA proposal would delay the already lengthy process of developing new psychiatric drugs.
Previously, in an earlier piece about the FDA psychiatric drug proposal, we had concluded with this remark: "We will watch to see whether the FDA stands its ground against Big Pharma on this change in course as regards the approval of new psychiatric drugs." Seemingly, we now have our answer.
The FDA will "very likely" take the advisory panel's suggestion, said Dr. Thomas Laughren, the FDA's director of the division of psychiatry products. Further, Dr. Laughren said that if and when the FDA ever establishes any new requirements for psychiatric drug studies, such a change would likely be customized for each type of psychiatric disorder -- as the panel advisory suggested.
In more detail, the FDA advisory panel members were unanimous in taking the position that the agency's current procedure -- allowing the drug companies to conduct their long-term studies on a drug's effectiveness in treating psychiatric illnesses after the drug is approved -- was superior to the recent FDA proposal.
This advisory panel was chaired by Dr. Wayne Goodman, the chairman of the psychiatry department at the University of Florida. Dr. Goldman acknowledged to reporters that he was concerned the public might "misinterpret" the advisory panel's vote as being generally against what would appear to be an FDA proposal "to raise the bar" on data required for new psychiatric drug approvals. Attempting to clarify the situation, Dr. Goldman said the panel's "No" vote was more about the fact that the panel had disagreed with the FDA's "one-size-fits-all" approach, and that the advisory panel was not against the underlying idea about a need for some change.
In fact, a few of the advisory panel members remarked that the FDA should be able to require that the drug companies provide long-term efficacy data within two years of their new psychiatric drug being approved and made available in the U.S. market -- which, to the surprise of some, the FDA cannot do at present.
(Posted by: Tom Lamb)