FDA — Pain Products Campaign: HHS Response to Rfr

03/07/2005

From: Food and Drug Administration

To:

Date: March 7, 2005

Dear Ms. Buc and Ms. Beardsley:

This letter responds to your October 22, 2004, request for reconsideration of complaint and request for correction pursuant to Section 515( a) of the Treasury and General Government Appropriations Act for Fiscal Year 2001, Pub. L. No. 106-554, 114 Stat. 2763A-153 (200Q) (the Federal Data Quality Act) concerning the Food and Drug Administration's (FDA's) Consumer Campaign on Safe Use ofOTC Pain Products (the campaign). Your original complaint, dated May 18, 2004, and the October reconsideration were submitted on behalf of your client, McNeil Consumer and Specialty Products (McNeil).

FDA has carefully reviewed your request for reconsideration and finds no new information that would compel the agency to amend the campaign at this time. Because FDA already addressed many of your statements in the August 25,2004, response, I will not repeat them here. Instead, I wish to address several of the broad statements you have made with regard to FDA's August response and the campaign. Before I do that, however, I would like you to know that the agency is considering some campaign modifications. Although sqme elements ofthe campaign are no longer amenable to change (e.g., the FDA Consumerarticle titled, "Use Caution With Pain Relievers," which appeared in the January-February 2003 issue), FDA may alter several ongoing elements, such as the print ads. The agency is also planning to make some format changes to the public service advertisement for non­steroidal anti-inflammatory drugs (NSAIDs) to highlight stomach bleeding and kidney problems if we use the advertisement in the future.

With regard to your October 22 request for reconsideration, you state that "FDA's response (dated August 25, 2004) does not dispute that the campaign as a whole creates the impression that acetaminophen is more dangerous than NSAIDs." In fact, the conclusion of our August 25 response explicitly states that "we do not believe that the campaign understates the risks ofNSAIDs or implies that acetaminophen is more dangerous than NSAIDs." Your October 22 request also states that FDA's response to your complaint focused "primarily on individual examples of statements that contribute to the campaign's lack of objectivity." The mainstay of yolir complaint that the campaign exhibited bias was your presentation of a cumulative collection of examples of statements made by FDA. In our response, we ,refuted each example to respond to your allegation regarding the collective effect of such statements.

Another statement in your October 22 request for reconsideration is that the campaign "as a whole, and certain elements of it, represent that acetaminophen is less safe than NSAIDs, as unequivocally demonstrated by the press response to the campaign" [emphasis added]. You have failed to provide any evidence to support your allegations regarding the nature of the press response. Moreover, the press coverage cannot be attributed to or controlled by FDA, and neither it nor your interpretation of it would constitute a substantive basis for our reconsidering the campaign's content.

After careful consideration of your request for reconsideration, we have concluded that the request does not provide a basis for further action regarding the campaign. In addition, we maintain that the education campaign, either as a whole or any of its parts, does not violate the Federal Data Quality Act standards for objectivity. In view of our decision, we do not feel that a meeting with McNeil concerning the campaign is warranted.