A Sept. 24 news story, "FDA Told Its Analyst to Censor Data on Antidepressants," mischaracterized the facts surrounding the production of information and materials by the Food and Drug Administration to congressional investigators looking into the agency's review of several antidepressants. FDA employees, including Donna Katz of the Office of Chief Counsel, followed all relevant procedures and worked for months to produce the more than 50,000 pages of documents and data that were requested by congressional investigators.

Rather than censoring FDA medical officer Andrew D. Mosholder, agency employees fully supported him in his efforts to comply with congressional investigators. When congressional investigators first asked to speak with Dr. Mosholder, the FDA's Office of Internal Affairs was conducting an internal investigation and, according to long-standing government policy, could not confirm or deny the existence of the investigation until it was completed. This policy is intended to protect the inte- grity of the investigation and the privacy of those being interviewed.

It was in this context that Ms. Katz proposed deleting from Dr. Mosholder's document certain nonsubstantive information that would have revealed the existence of the investigation. The probe was completed before Dr. Mosholder met with congressional investigators, however, so we disclosed the existence of the completed investigation and produced all relevant documents, including the original affi- davit. The agency explained these facts to congressional investigators before the hearing, both orally and in writing.

All of the FDA's employees performed with integrity and the highest ethical standards in responding to congressional investigators during their lengthy investigation.


Acting Commissioner

Food and Drug Administration