FDA Responds on Rezulin

* “Risk Was Known as FDA OKd Fatal Drug” (March 11) contained partial truths and innuendoes about the Food and Drug Administration’s handling of the diabetes drug Rezulin. The article’s claim that Rezulin (also known by its generic name troglitizone) “had not been proved to save lives or to reduce the serious complications of adult-onset diabetes” is true but irrelevant, because that is not the standard the FDA uses for approving any diabetes drug. Rather, all approved diabetes drugs in the U.S. must demonstrate their ability to help “normalize” blood sugar levels, thereby helping to control the many serious and life-threatening risks of diabetes.

The FDA also plays a unique public health role in the drug development process by meeting frequently with researchers and product sponsors to foster the availability of significant new treatments, especially those for serious and life-threatening conditions. Far from being nefarious or underhanded, this is standard FDA practice. Listening to alternative perspectives is a routine part of how the FDA conducts its business. Listening is not, however, tantamount to doing a company’s bidding. The FDA strives to be accountable to the public it serves and to carry out its business with openness and transparency.

The article suggests that Dr. Murray “Mac” Lumpkin played a pivotal role in FDA’s handling of troglitizone. Lumpkin was not the final decision-maker on the approval of troglitizone. The FDA feels compelled to correct some of the specific errors in the report:

* The article says that Lumpkin discussed this drug with a company executive during a “drug-industry trade group” meeting which was in fact a meeting with officials of the Drug Information Assn., a neutral, not-for-profit organization that works to improve the drug education and regulatory process. Lumpkin’s participation in DIA activities is an approved “outside activity” under government ethics rules.

* Lumpkin was not the official who would have determined whether FDA documents were releasable under the federal Freedom of Information Act. The FDA’s policy, supported by federal law, has long been not to release draft documents under FOIA.

* Dr. John Gueriguian was relieved of his duties for reasons unrelated to his scientific reviews, a decision that had the concurrence of the most senior FDA officials.

One last point: The article focuses solely on risks from troglitizone, ignoring its benefits. All other approved diabetes drugs also have rare, but serious, side effects. Because these drugs’ benefits for diabetics outweigh the risks of their use, however, they remain approved and on the market.

LINDA A. SUYDAM

Senior Associate Commissioner

BERNARD A. SCHWETZ

Acting Principal Deputy

Commissioner, FDA