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This article was originally published in The Tan Sheet

Executive Summary

FDA DRUG ADVERSE EVENT REPORTS WILL BE AVAILABLE TO MANUFACTURERS within 10 days of receipt under a pilot program slated to begin in July. In a June 3 letter, FDA notified manufacturers and applicants of drugs and biologics of a "one-year pilot study designed to test the agency's ability to expedite the transmission of serious adverse event reports." The letter was disseminated in conjunction with a same-day conference on the agency's new adverse event reporting program, MedWatch, held in Rockville, Md. "If you decide to participate in the pilot study," the letter states, FDA "will send directly reported serious adverse event reports to you by regular mail within approximately 10 working days of their receipt by the agency. In return, FDA expects that you will conduct prompt follow-up of these reports through your routine procedures, and that you will share the data you obtain with FDA." Companies wishing to participate in the study must send FDA a letter of intent. The pilot study letter explains: "The letter must contain: a list of your firm's products (including brand name/generic name, and application number) about which you wish to receive expedited serious reports"; "a statement certifying that you have the regulatory responsibility for postmarketing reporting of adverse experiences for the product(s) you have identified; [and] a statement that you will maintain the confidentiality of the names of the reporters and the persons who are the subjects of these reports." The study consists of two six-month phases. Phase one starts July 1 and runs through Dec. 31; Phase two begins Jan. 1, 1994 and ends June 30, 1994. Letters of intent should be mailed to: MedWatch: The Medical Products Reporting Program, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787. Although it covers OTC drugs, the MedWatch program is distinct from the agency's effort to develop an ADR system for monographed OTC drugs. The separate OTC program is expected to appear as a proposed rule in a Federal Register notice this fall ("The Tan Sheet," May 24, p. 1). At the MedWatch conference, newly appointed program director Dianne Kennedy explained the impetus for the pilot study. "We met with representatives of the [Pharmaceutical Manufacturers Association] and we heard their concerns about being left out of the loop [of ADR] reporters that reported to FDA instead of the manufacturers." FDA's MedWatch program, officially unveiled at the conference, is designed to encourage health professionals to report serious adverse events and make the reporting process easier for health professionals and for manufacturers of OTC and Rx drugs, biologics, devices, dietary supplements, medical foods and infant formulas. As part of the MedWatch program, FDA has begun distributing a "Desk Guide for Adverse Event and Product Problem Reporting" to health professionals, which includes a new common reporting form, instructions for completing the reporting form, instructions for reporting by modem, sample reports, descriptions of serious adverse events and product problems, and case studies. The number for reporting by modem is 1-800-FDA-7737 and by FAX is 1-800-FDA- 0178. Reporting forms and desk guides can be ordered by calling 1- 800-FDA-1088. The agency plans to hold a workshop in 1994 to increase physician awareness of drug- and device-induced disease. The agency provided a brief introduction to MedWatch at a May 3 meeting with health professional associations ("The Tan Sheet" May 10, p. 7). Part of the MedWatch program involves the development of the common reporting form for drugs, biologics, devices, dietary supplements and other regulated products. The final version of the form was published in the June 3 Federal Register and distributed at the conference. The reporting regs will revise the regulatory definition of "serious" as it is applied to adverse experiences with drugs, biologics and devices. The new reporting form lists definitions of serious outcomes that should be reported: "death"; "life- threatening"; "hospitalization -- initial or prolonged"; "disability"; "congenital anomaly"; "requires intervention to prevent permanent impairment/damage"; and "other". FDA has added the need for intervention and dropped use of "cancer" and "overdose" as descriptors of "serious" outcomes. Addressing the conference, FDA Commissioner David Kessler said one of the triggers for getting MedWatch "off the ground" was a discussion he had "a year-and-a-half ago" with American Medical Association Exec VP James Todd about the breast implant controversy. "We were saying to each other . . . how do we make sure that we don't end up in that situation again?" Kessler said. Kessler noted that many health professionals do not think to report adverse events or they are hesitant to file reports. In an article in the June 2 Journal of the American Medical Association, Kessler wrote that "only about 1% of serious events are reported to to the FDA, according to one study." "One factor . . . inhibiting reporting is the fear of some practitioners that their identity will be released in court cases," Kessler told the conference. FDA has "succeeded in maintaining the confidentiality of this information in every single case in which we have participated," Kessler pointed out. FDA has the regulatory authority to protect the identity of reporters and patients. Nonetheless, the agency is concerned about the issue of practitioner confidentiality in some recent court cases. As a result, Kessler said, the agency is "planning to propose a regulation to strengthen the confidentiality of the information on the reporting form." FDA Associate Chief Counsel for Drugs Catherine Lorraine told the conference that the agency hopes to have "something to show you sometime soon and that means in 1993." FDA Office of Special Nutritionals Director Elizabeth Yetley, PhD, observed that many dietary supplement products are regulated as foods, which have different reporting requirements. "Therefore," she added, "FDA is extremely dependent upon health professionals for reporting adverse effects to learn of possible health hazards associated with these products." She said it was FDA's "general impression" that physicians "do not always ask about use of these types of products when developing a medical history on a patient."

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