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This article was originally published in The Gray Sheet

Executive Summary

ADVERSE INCIDENT CONFIDENTIALITY REG TO BE DEVELOPED BY FDA, the agency declared at a June 3 conference on MedWatch, the agency's medical products reporting program. "We are planning to propose a regulation to strengthen the confidentiality of the information on the reporting form" for adverse incidents, FDA Commissioner David Kessler said. Specifically, the reg would focus on preempting state laws that require medical product manufacturers to release the names of adverse event reporters or patients in court. Maintaining reporter confidentiality has been a point of concern for FDA and physicians. In a recent letter to the agency, the American Medical Association noted that concerns about confidentiality discourage many physicians from making voluntary reports ("The Gray Sheet" May 3, p. 8). At the June 3 conference, Catherine Lorraine, associate chief counsel for drugs at FDA, noted that "the FDA right now...has the regulatory authority and has exercised it on a number of occasions to protect the information concerning identity of reporters." She added, however, that "increasingly manufacturers who have much of this information are being asked to produce this in product liability cases," which has led the agency to propose the development of a regulation. Lorraine said the agency hopes to formulate a formal proposal in 1993. FDA's MedWatch program, officially unveiled at the June 3 conference, is designed to encourage health professionals to report serious adverse events and make the reporting process easier for both providers and manufacturers. The agency provided a brief introduction to MedWatch at a May 3 meeting with health professional associations ("The Gray Sheet" May 10, I&W-4). In conjunction with the MedWatch program, FDA has developed a common reporting form for devices, drugs, biologics, 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. There are two versions of the reporting form. FDA Form 3500 is for voluntary reporting by health professionals and is effective immediately. FDA form 3500A is for mandatory reporting by manufacturers, device distributors and user facilities. According to the Federal Register notice, "medical device manufacturers, distributers, and user facilities will be required to use Form 3500A when the agency has finalized the respective adverse event reporting regulations for these entities." Chester Reynolds, director of the postmarket management staff in the Center for Devices and Radiological Health, noted that the device regulations, which detail reporting rules for user facilities and distributors and revise the existing manufacturer reporting requirements, are due " August or September." FDA is encouraging use of Form 3500A by device manufacturers, distributers and user facilities prior to the effective date. Reynolds pointed out that adverse event reporters have an "opportunity to use the...form and give us feedback between now and when the form" becomes effective. He added that the agency will continue to consider further revision of the forms. The new form retains inclusion of the terms "hospitalization," "disability" and "congenital anomaly" as choices under reasons for reporting an incident. The Health Industry Manufacturers Association had requested that the agency remove these categories from consideration for a device-related incident, asserting that device law does not require manufacturers to make adverse reports for these types of events ("The Gray Sheet" April 19, p. 22). In the June 3 Federal Register notice, the agency explains that "this section is for the general reporting and description of the event. FDA does not want to limit the choices of reasons for reporting in this general section, but would rather leave the reporter all the options that might be applicable." During a press briefing prior to the conference, Kessler noted that one impetus for creation of the MedWatch program was the silicone gel breast implant controversy. He said that he had spoken with James Todd, MD, executive vice president of the AMA, "a little after the breast implant controversy, and what we were saying to each other is how do we make sure that we don't go thirty years and not have basic data?...How do we get physicians and dentists and nurses and pharmacists and everyone to report problems?" At the conference, FDA also released a partial draft of a standard that would allow manufacturers to use electronic data interchange (EDI) to submit adverse event reports to the agency. The agency intends that the "use of contemporary computer and communication technology" should help it handle the "increase in the rate of reporting" due to the MedWatch program, which it estimates will result in a rise of "several hundred percent." FDA plans to begin a pilot program of the standard for electronic submissions at CDRH in the summer of 1993 "with a small number of trading partners." CDRH will host a July 13 public meeting in Rockville, Maryland that will focus on "event reporting issues including EDI." FDA says that the meeting's morning session "will be oriented to statutory, regulatory, guidelines, instructions, etc. related to reporting. The afternoon session will be dedicated to electronic reporting."

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