FDA’s Regulatory Decisions Concerning Palladone August 16, 2005 The Honorable Lester M. Crawford, D.V.M., Ph.D. Commissioner Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Dear Dr. Crawford: We write to you about an important drug-safety issue arising from the Committee’s oversight of the FDA’s regulatory decisions concerning Palladone, described by FDA as “a once-a-day pain management drug containing a very potent narcotic.” On July 13, 2005, the FDA requested Purdue Pharma, L.P. (“Purdue”) to withdraw the painkiller prescription drug, Palladone, from the market because of concerns that patients could die from taking the drug together with alcohol. In reviewing how and why the FDA approved and later requested the withdrawal of Palladone, the Committee staff learned that while Palladone was still marketed, FDA posted on its website only safety information about the risks of alcohol interaction with Palladone as reflected in the language of the labeling and medication formally approved by the FDA. However, after approving Palladone in September 2004 but prior to the product’s launch in November 2004, the FDA permitted Purdue under a special process called a CBE (Changes Being Effected) supplement, to use stronger labeling and medication guide language about the alcohol risks shown in early results of studies conducted by Purdue that began in early September 2004. That safety language, which was in fact the actual labeling and medication guide used in the marketing of Palladone, was reflected on Purdue’s website but not on the FDA ‘s website. Thus, we note that the alcohol interaction information posted on the FDA’s website, dated September 24, 2004 is listed on the fourth page of the medication guide and states: “Do not drink alcohol while using Palladone. It may increase your chance of getting dangerous side effects.” (See Attachment One.) In contrast, the medication guide actually on the market as reflected on Purdue’s website, dated November 16, 2004, expressly states on page 1, “Do not drink alcohol while taking Palladone Capsules.” Moreover, it states that, “drinking alcohol while taking Palladone capsules . . . can release the full twenty-four hour dose into your body all at once. This is very dangerous. You could die from an overdose of the medicine.” (See Attachment Two). While there was no final FDA approval for the Purdue label with the alcohol warning language, the Committee is concerned that patients and practitioners who accessed the FDA website were not informed of the most current safety risks of Palladone and alcohol interaction. Updating such information even without final FDA approval is vital to ensuring the safety of American consumers taking prescription drugs. We note that the Committee staff recently questioned the FDA about why the agency did not include the updated labeling and medication guide information for Palladone on the FDA website. FDA staff told the Committee staff that the agency was taking measures (through electronic labeling and more proactive public health advisories) to ensure drug safety information was as current as possible. We are committed to ensuring that the FDA provides the most current and accurate drug safety information to the American public. Likewise, you have stated that the FDA is “fully committed to advancing the public health by . . . helping the public get the accurate, science-based information they need to use medicines and foods to improve their lives.” The Committee is appreciative and encouraged by the FDA’s statement that the agency is moving proactively with public health advisories and electronic labeling. We are interested in learning more about these proactive measures and other related actions. In furtherance of helping the American public get the most current and accurate drug-safety information from the FDA, we respectfully request a written response by October 14, 2005, detailing: (1) a list as of July 1, 2005 of any other drugs besides Palladone for which the labeling and medication guide information on the FDA website has been superceded by new labeling and medication guide information permitted under a CBE supplement but not finally approved; (2) the specific actions taken by FDA, including the dates these actions have been taken or will be taken, to ensure that the agency’s website reflects the most current safety information about approved drugs (or other FDA-approved products generally). If you have any questions, please contact Alan Slobodin of the Committee staff at (202) 225-2927. We look forward to working with you to advance public health.   Sincerely,   Joe Barton  Chairman Ed Whitfield Chairman, Subcommittee on Oversight and Investigations Attachment 1 (PDF) Attachment 2 (PDF) cc: The Honorable John D. Dingell, Ranking Member The Honorable Bart Stupak, Ranking Member Subcommittee on Oversight and Investigations ####