Drug Companies Keep the World in the Dark About Why the FDA Rejects New Drugs

When the U.S. Food and Drug Administration (FDA) declines to approve a new drug, the world rarely finds out why the product was rejected.  A recent FDA analysis published in the new issue of British Medical Journal (BMJ) found the pharmaceutical industry’s communications about rejections to be insufficient and misleading, at best.

The analysis examined what pharmaceutical companies tell investors and the general public when the agency rejects a drug. At best, the industry’s communications are insufficient and misleading. At worst, BMJ found the communications to be close to outright lies. Investors faced with an FDA rejection should never believe anything that drug company executives have to say unless the full text of the rejection letter is made public. In the span of BMJ’s analysis – August 11, 2008 to June 27, 2013 – no company released the full text of an FDA rejection letter, according to Forbes, who viewed the report.

Current FDA regulation means that the agency does not publish its rejection letters or complete response letters. FDA researchers led by Peter Lurie, the Associate Commissioner for Public Health Strategy and Analysis at the FDA and a former researcher at the consumer gadfly group Public Citizen, worked around this by breaking up complete response letters, resulting press releases and filings to the U.S. Securities and Exchange Commission (SEC) into discrete statements. Then, the analysts counted how often the statements in the press releases (or, in a separate analysis, the SEC filing) matched what was actually in the rejection letter, Forbes explained.

Twenty-one percent (13) of the press releases did not contain any of the details from the FDA’s complete response letters. Press release statements matched only 93, or 14%, of the 687 statements about reasons for rejection contained in the complete response letters.  This increased to 101, or 15%, when the analysis of SEC filings was concluded, according to Forbes.

Drug companies are only required to include the bare details of why their drug was rejected, and press releases are generally less informative than the FDA’s rejection letters. This leaves investors and other drug developers in the dark. Forbes first reported on this problem seven years ago. John Jenkins, director of the FDA’s Office of New Drugs, said at the time: “One thing I’ve said now for several years is, if a company is telling you about the letter, I would ask to see the letter, because that’s the only way to know what the FDA said.”

Drug companies say the letters should remain confidential, but Forbes pointed out that “One of the best ways to understand what you need to do to get your drug approved is to know where others went wrong.”

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from Parker Waichman http://www.yourlawyer.com/blog/drug-companies-keep-the-world-in-the-dark-about-why-the-fda-rejects-new-drugs/