"[P]eople acting in a group can accomplish things which no individual acting alone could even hope to bring about." - FDR

News & Analysis | REG•WATCH Blog | Press Room

Wednesday, January 23, 2008

Industry Pushing for Drug Marketing Loophole

In November, Reg•Watch blogged about an FDA proposal that would allow drug companies to market drugs for unapproved uses by passing out journal articles and other studies. In a letter to FDA Commissioner Andrew von Eschenbach, Rep. Henry Waxman — whose committee had discovered the proposal — complained that, by creating the loophole, drug companies could promote their drugs using studies they fund themselves, free from FDA oversight.

After some prodding by Waxman's committee, FDA turned over a memo from a meeting between FDA officials and drug industry representatives including Dan Troy, a former FDA chief counsel. In another letter to von Eschenbach, Waxman expresses concern:

According to this memorandum, Mr. Troy and the other drug company representatives urged you to issue FDA guidance allowing the distribution of journal articles promoting off-label uses to protect the drug companies from "Federal prosecutors pursuing distributors of this information for criminal conduct."

This document raises questions about the rationale for the draft guidance.

For now, that's the end of the story, because FDA has refused to turn over any more documents relating to the proposal. FDA claims those documents are "predecisional" and therefore privileged information.

Never deterred by the administration's obstructionism, Waxman is demanding more information:

In your December 2l letter, you state that you are not providing the Committee with other documents or answering the Committee's questions because this information is "predecisional." This is no basis for withholding from the Committee communications about the use of joumal articles that FDA received from private drug companies. This is also no basis for withholding internal FDA communications where — as in this case — there is evidence that FDA's actions may be unduly influenced by regulated companies.

For copies of letters and more information from Waxman's committee, click here.