Executive Summary

PFIZER REQUESTING IMMEDIATE FDA ACTION ON FELDENE IMMINENT HAZARD PETITION filed by the Health Research Group (HRG) in January. In a May 5 letter to FDA, Pfizer waived claims of confidentiality to most of the documents the firm submitted to the Feldene (piroxicam) NDA in March and objected to HRG's request that FDA delay final action on the petition until HRG comments on the disclosed documents. "A delay to permit HRG to file further comments cannot be reconciled with HRG's allegation that Feldene presents an 'imminent hazard,' is not provided for in FDA's procedures, and is not required for the purpose of providing the decisionmakers FDA and HHS with any data," Pfizer asserted. Pfizer added that the pendency of the petition "and the surrounding publicity generated by HRG, have caused serious distress to elderly patients and to others for whom Feldene has been prescribed." The firm noted that "within the last month, HRG undertook a mass mailing of its Health Letter with a lead article on Feldene under the headline 'Another Dangerous Drug.'" HRG's article in the March/April issue of Health Letter states: "As was the case with the now-banned Lilly arthritis drug Oraflex, Pfizer hoped to cash in on an understandable and well documented desire of arthritis-sufferers: to take as few pills as possible . . . But the fact that the drug lasts long enough in the body to require only one pill a day means that people who have an impaired ability to excrete any drug may get into extra trouble with such drugs." The article adds that in comparison to other arthritis drugs, Feldene "takes anywhere from three to 40 times longer to clear from the body in normal people." The article advises: "If you are over 60 and are using Feldene, go to your doctor and ask to be switched to another, older arthritis drug with a more well-established safety record. Second, the next time a doctor recommends any new drug for you, ask how long it has been on the market and whether there is evidence that it is an important therapeutic advance over existing drugs for treating your medical problem, be it arthritis or any other disease. If the drug is not an important advance over older drugs (nine out of 10 new drugs are not) and if it has not been on the market for at least four years, do not allow yourself to become part of the process of learning how dangerous the drug is." Pfizer also said HRG "provided for publication overseas" the analyses the consumer group presented at FDA's public hearing on Feldene Feb. 28. A letter in the April 26 issue of Lancet includes a table, courtesy of HRG Director Sidney Wolfe, of drug-related gastrointestinal adverse reactions "observed/expected" on basis of prescribing share of drug for seven nonsteroidal anti-inflammatory drugs. Pfizer said the letter "does not take into account any of the epidemiological criticisms leveled during FDA's hearing." With regard to the material submitted to the Feldene NDA on March 17, Pfizer said it consisted of five volumes and a letter. One of the volumes and the letter responded to requests made by FDA Center for Drugs and Biologics Director Harry Meyer for information on "dermal reactions associated with Feldene and pending foreign regulatory proceedings involving Feldene," Pfizer stated. The firm said one of the volumes consisted of more detailed analyses regarding GI toxicity and the remaining three volumes covered the pharmacokinetics of Feldene. Pfizer claimed confidentiality for three categories of materials in these volumes: "(1) the detailed displays of the safety and pharmacokinetic data that support the data summaries submitted to the public docket for the HRG proceeding; (2) the detailed descriptions of Pfizer's study designs and methods for analyzing its data; and (3) the information regarding pending foreign regulatory proceedings involving Feldene."