[Federal Register Volume 59, Number 18 (Thursday, January 27, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-1640] [[Page Unknown]] [Federal Register: January 27, 1994] _______________________________________________________________________ Part III Department of Health and Human Services _______________________________________________________________________ Food and Drug Administration _______________________________________________________________________ 21 CFR Part 20 Protecting Identities of Reporters of Adverse Events and Patients; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food And Drug Administration 21 CFR PART 20 [Docket No. 93N-0334] Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its public information regulations to help ensure that the identities of those who report adverse events associated with human drugs, biologics, and medical devices, and the identities of patients are held in confidence and not disclosed by FDA, as provided in current agency rules, or by manufacturers that possess these reports. The proposed rule is intended to preempt the establishment or continuation in effect of any State or local law, rule, regulation, or other requirement that requires or permits disclosure of such identities. This action is being taken to maintain the agency's ability to collect information about safety risks of FDA-regulated products that is vital to protection of the public health. DATES: Comments by March 28, 1994. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Ilisa B. G. Bernstein, Office of Policy (HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-2831. SUPPLEMENTARY INFORMATION: I. Background A. Introduction A critical public health activity of FDA is to monitor the safety of human drugs, biologics, and devices in the marketplace. As part of postmarketing surveillance programs to monitor the safety of these products, FDA relies heavily on its adverse event reporting systems. These reporting systems are important adjuncts to the product approval process, which is based primarily on testing conducted before a product is marketed. Although preapproval testing provides significant information about the safety and efficacy of a product, not all potential safety problems can be identified in the preapproval stage when the number of subjects exposed to the product and the period of exposure are necessarily limited. For that reason, the receipt of postmarket reports of adverse events associated with a regulated product is critical to the agency's ability to help protect the public health. Reporting by physicians and other health care professionals of adverse experiences associated with the administration of most products is strictly voluntary. As the agency's primary source of adverse event information, this voluntary reporting system has revealed significant adverse events and drug interactions associated with products that could not be identified during the preapproval testing. There are many instances of important public health actions that have been the direct or indirect result of information provided through voluntary reporting by individual health professionals. The removal of the antibiotic temafloxacin (Omniflox) from the market, research concerning the danger of concurrent use of the antihistamine terfenadine (Seldane) when taken with either the antifungal ketoconazole or the antibiotic erythromycin, and the warning labeling requirement for latex products are just a few examples that demonstrate why FDA strongly encourages voluntary reporting by physicians and other health professionals. In a major effort to increase voluntary reporting of serious adverse events by health professionals, FDA recently announced a new reporting system called MEDWATCH. This program is designed to make it easier for health care providers to report serious adverse events and to clarify what type of information should be reported. The agency believes that preserving the confidentiality of the identities of the patient and of third parties involved with an adverse event report, such as the physician or others identified in the report, is essential to the success of the adverse event reporting system. Accordingly, although the substantive content of adverse event reports is public information under the Freedom of Information Act (FOIA), 5 U.S.C. 552, FDA regulations have long protected the confidentiality of the patient, reporter, and institution involved in the adverse event (Sec. 20.111 (21 CFR 20.111)). These regulations, which have been in place since 1974, have enabled FDA to obtain voluntary reports of adverse events and to protect the confidentiality of information that could identify the patient involved. Although these regulations protect the release of confidential information by FDA, they do not protect the release of the same information contained in reports held by drug, biologic, and device manufacturers. Various State and local governments have laws, regulations, or rules that permit disclosure of this information in litigation, through discovery or otherwise. Recently, plaintiffs in several product liability and medical malpractice cases have attempted to discover the identities of reporters and patients named in adverse event reports in the possession of the product manufacturers. As discussed above, this same information is protected from public disclosure when it is contained in similar or identical reports submitted to FDA and in FDA's possession. To avoid jeopardizing the willingness of the health care community to make reports of adverse events to manufacturers and FDA, the agency believes that a similar confidentiality rule is needed to prevent disclosure or threats of disclosure of the identity of reporters or subjects of adverse event reports in the possession of manufacturers. To ensure meaningful reporting under the new MEDWATCH program, FDA believes that additional steps must be taken to safeguard the confidentiality of the identities of those involved with adverse event reports. State and local laws, regulations, or rules that permit or require the disclosure of patient and reporters' identities interfere with the agency's objective of ensuring the safety of human drugs, biologics, and devices. Therefore, FDA is proposing to amend its regulations to prohibit the disclosure of such information contained in reports held by FDA, as provided currently, and similar information held by manufacturers. The proposal also would preempt State and local laws, regulations, or rules that permit or require such disclosure. Disclosure would be permitted if both the reporter and the person identified in the report consent to disclosure or if there is a discovery order in malpractice litigation between the subject of the report and the reporter of the adverse event. B. FDA Adverse Event Reporting Programs 1. Drug and Non-Vaccine Biological Products FDA receives postmarketing adverse drug reaction (ADR) reports directly from manufacturers, health professionals, and consumers. An adverse drug or biologic experience means any adverse event associated with the use of the product in humans, whether or not the event is considered related to the drug or biologic. Included are events that occur in the course of professional use, from drug overdose (whether intentional or accidental), from drug abuse, from drug withdrawal, and any failure of an expected pharmacological action (Sec. 314.80 (21 CFR 314.80(a)). FDA regulations require drug manufacturers to report to FDA serious and unexpected adverse reactions and increased frequency of serious expected reactions. These reports must be filed within a specific time after the manufacturer receives the information. Manufacturers are also required to submit periodic reports of all adverse reactions (Sec. 314.80). FDA has proposed similar adverse experience reporting requirements for manufacturers of licensed biological products (March 29, 1990, 55 FR 11611) and expects to publish final regulations in the near future. The reporting of these adverse reactions by health professionals to either manufacturers or FDA, however, is strictly voluntary. (Health care providers are required to report certain adverse events associated with specific vaccines under the National Childhood Vaccine Injury Act. See section I.B.3 of this document.) The agency is also preparing a proposed rule to require adverse drug reaction reporting by manufacturers of nonprescription drug products. In 1992, the agency received 105,945 ADR reports. The majority of the reports (88 percent) were sent by manufacturers, while the remaining 12 percent were sent directly to FDA by health professionals or consumers. Of all the ADR reports received by the agency, 22,704 were considered serious. FDA believes that these figures represent only a fraction of the serious adverse events encountered by health care providers. A recent review article found that between 3 and 11 percent of hospital admissions could be attributed to adverse drug reactions (Ref. 1). Only about 1 percent of serious events are reported to FDA, according to one study (Ref. 2). Another study states that reporting rates in the United States are apparently lower than those in some other countries (Ref. 3). The majority of studies that have investigated the occurrence of adverse drug events in hospitalized patients estimate that from 10 to 20 percent of all patients will experience an adverse drug event while hospitalized (Ref. 4). Upon receipt of the ADR report, the agency enters the information into its computerized data base of all ADR reports, the spontaneous reporting system (SRS). Every report of a serious adverse reaction is evaluated for its potential significance. The agency determines whether similar incidences were reported in the SRS, the temporal relationship between the administration of the drug and the reaction, possible confounding factors, and other information related to the adverse event. In many cases, follow-up information is requested from the reporter or the manufacturer. Because of resource constraints, the agency often relies on the manufacturer to screen the ADR reports and conduct any necessary follow-up by contacting the reporter. For this reason, similar or identical reports of adverse drug events will be in the possession of both FDA and individual drug manufacturers. Information provided by voluntary reports from health professionals alerted FDA that the recently approved antibiotic temafloxacin (Omniflox) was associated with a serious type of anemia. Because of the severity of the risk associated with this drug, which became apparent only after the product was approved and used in larger numbers of patients, it was removed from the market. ADR reporting from health professionals also prompted FDA to undertake research that showed that a fatal reaction could occur when the antihistamine terfenadine (Seldane) is taken in combination with the antifungal ketoconazole (Nizoral) or with the antibiotic erythromycin. Drug interactions also reflect the fact that individual variability in drug metabolism can account for significant differences in patient response. Such response differences make well-designed postmarketing studies and health care provider observations and reports especially important. Other examples of FDA actions prompted by ADR reports include: The alert that serious liver damage may be associated with labetalol, a drug for high blood pressure; the recall of the nonnarcotic pain relieving drug zomepirac (Zomax), after reports that it may cause a severe allergic reaction that can result in death; the alert that the use of the antibiotics in the fluoroquinolone class and the anticoagulant warfarin may result in increased blood clotting time, which can lead to hemorrhage; and the recent boxed warning and alert to health professionals regarding the use of angiotensin converting enzyme (ACE) inhibitors during the second and third trimesters of pregnancy. 2. Devices Postmarketing surveillance of the safety of devices depends on the success of both required and voluntary systems of reporting. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (Pub. L. 94-295) (the 1976 amendments) (21 U.S.C. 360i) and the Safe Medical Device Act of 1990 (Pub. L. 101-629) (the SMDA) (21 U.S.C. 360i(e)), and regulations thereunder, require manufacturers and distributors of devices to submit reports to FDA, within a specific timeframe, of deaths and serious injuries related to certain devices and of malfunctions. The SMDA also requires device user facilities, such as hospitals, nursing homes, and outpatient treatment centers, to report to FDA and the manufacturer, within a certain timeframe, information that reasonably suggests that a device has or may have caused a death. Device user facilities also are required to report to the manufacturer, or to FDA if the manufacturer is unknown, information that reasonably suggests that a device has caused, or may have caused, or may have contributed to a serious illness or serious injury. Since 1973, the agency has maintained a voluntary device problem reporting program. Last year, about 4,500 reports were voluntarily submitted to this program, in addition to the statutorily required reports from manufacturers, distributors, and user facilities. Both the voluntary and the statutorily required reporting systems for devices, as with those for drugs, ultimately depend on the willingness of the individual health care professionals to submit reports. In 1991, voluntary reporting led the agency to alert health professionals to a potentially fatal hypersensitivity to latex products. In addition, through the voluntary reporting system, FDA learned of increased numbers of deaths associated with physical patient restraints, often used by hospitals and nursing homes to restrain patients. Based on these reports and other information, FDA has restricted patient restraint devices to prescription use only and has taken steps to ensure proper labeling to prevent deaths and injuries. After receiving a report by a physician about two patients who experienced blindness after the physician's use of an ophthalmic device during eye surgery, FDA investigated the manufacturer and initiated a recall to remove these devices from the market. In some areas, however, inadequate reporting has fostered delays in detecting problems. One example is silicone breast implants. Although these devices had been on the market for over 30 years, only in recent years had evidence begun to accumulate about their possible association with autoimmune-like disorders. Had the agency received reports from health care providers when they initially observed these disorders in patients with breast implants, the agency could have assessed this possible association at an earlier date. 3. Vaccines The National Childhood Vaccine Injury Act of 1986 (the NCVIA) requires health care providers who administer certain vaccines and manufacturers of those vaccines to report to the Government specified adverse events (42 U.S.C. 300aa-25). All reports are made to the Vaccine Adverse Event Reporting System (VAERS), which is maintained by FDA and the Centers for Disease Control and Prevention (CDC). FDA strongly encourages health care providers to report all suspected adverse events related to vaccines, in addition to those required to be reported by law, to VAERS. Reports submitted to VAERS are evaluated by FDA and CDC to identify vaccine-specific incidence and adverse event trends. For reports made pursuant to the NCVIA, the identity of the patient or the patient's legal representative cannot be made available to the public. However, for such reports, the identity of the health care provider is available to the public (42 U.S.C. 300aa-25(c)). For vaccine adverse event reports not submitted pursuant to the NCVIA, for example, for vaccines other than certain childhood vaccines, the identities of the patient, reporter, and institution involved are not disclosed to the public under FOIA. 4. The MEDWATCH Program The goal of FDA's new MEDWATCH program is to underscore the important role of health care providers in identifying and reporting serious adverse events that may be related to FDA- regulated products. The program will make it easier for health care providers to report adverse events, clarify the type of reports that should be made, more widely disseminate information on FDA actions that have resulted from adverse event reporting, and increase physician awareness of drug- and device-induced disease. Under the MEDWATCH program, several separate forms previously used to report adverse events and product problems with various products have been consolidated into a single, one page reporting form. Health professionals can use this form for reports on drug products, biological products, devices, and special nutritional products (dietary supplements, medical foods, and infant formula). The unified reporting form will be more readily available to providers in several publications and from a 24-hour, 7-days-a-week toll free number operated by FDA. There is also now a single receipt point for these reports; no longer will providers be expected to send different reports for medications and devices to different places in FDA. Health professionals can send the reports to the agency via facsimile or can report electronically by computer, responding to questions that appear on the monitor's screen. Health professionals can also send reports to manufacturers, who in turn will transmit them to FDA. Device manufacturers, user facilities, and distributors subject to mandatory reporting requirements will continue to submit their reports as specified in the applicable regulation. The important message of the MEDWATCH program is that health professionals should report any event that is suspected to be related to an FDA-regulated product and is associated with a serious outcome such as death, a life-threatening condition, initial or prolonged hospitalization, disability, congenital anomaly, or an event that requires intervention to prevent permanent impairment or damage. The object is to capture as many reports of serious adverse events as possible in order to use that information to enhance the safety of FDA- regulated products. In general, the agency does not care whether the voluntary report goes directly to FDA or to the manufacturer--as long as the event is reported. Many segments of the health care community have long supported agency efforts to increase voluntary reporting of adverse events by professionals. The practice standards for the American Society of Hospital Pharmacists contain a statement that ``pharmacists in organized health-care settings should develop ongoing programs for monitoring and reporting ADRs'' and should ``[r]eport serious or unexpected ADRs to FDA'' (Ref. 5). The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has standards for monitoring and reporting adverse medication and device events (Ref. 6). These standards require hospitals to report unexpected or significant adverse reactions promptly to FDA and to the manufacturer. To further support FDA's voluntary MEDWATCH program, the American Medical Association's (AMA) Council on Ethical and Judicial Affairs recently released an opinion memorandum in 1993 that it is a physician's ethical responsibility and obligation to communicate any suspect occurrence of an adverse reaction to a drug or device to the medical community, including FDA. II. The Problem--Confidentiality of Reporters' Identities FDA believes that its success in encouraging health professionals to participate in the voluntary adverse event reporting system depends substantially on the guarantee of confidentiality given the identity of the reporter under FDA regulations (Secs. 20.111(c)(3), 314.430(e)(4), 601.51(e)(3), and 803.9(b)). When FDA receives a request from the public for adverse reaction reports submitted voluntarily by health care professionals, consumers, patients, or manufacturers, FDA regulations require public disclosure of those reports only after deletion of the following: (1) The names and any information that would identify the person using the product, and (2) the names and any information that would identify any third party involved with the report, such as a physician, hospital, or other institution (Sec. 20.111). The rationale for this policy was first articulated in the Federal Register of December 24, 1974, in the preamble to FDA's public information regulations. At that time, FDA determined that without a guarantee of confidentiality, ``the possibility of persuading health professionals voluntarily to submit adverse reaction information is substantially diminished, and indeed perhaps wholly destroyed'' (39 FR 44602 at 44616). In the SMDA amendments, Congress provided some additional protection from involvement in private civil lawsuits to physicians who submit voluntary reports concerning adverse device events. Section 519(b)(3) of the act (21 U.S.C. 360i(b)(3)), added by the SMDA, provides that: [n]o report made under [the device user facility requirements] by a physician who is not required to make such a report, shall be admissible into evidence or otherwise used in any action involving private parties unless the facility, individual, or physician who made the report had knowledge of the falsity of the information contained in the report. Congress enacted this provision to encourage private physicians to notify FDA or the manufacturer of device problems (H. Rept. 808, 101st Cong., 2d sess. 21 (1990)). This provision, however, may not be sufficient to prevent manufacturers from being compelled to release the reporters' or patients' identities pursuant to a discovery order. The policy and program considerations underlying the need to protect patient and reporter confidentiality have become even more compelling in recent years. The increase in product liability and medical malpractice litigation has heightened the reluctance of health professionals to report events observed by them if they are not given meaningful promises of confidentiality. In addition, the potential for discrimination connected with a diagnosis of human immunodeficiency virus (HIV)-positive status or acquired immunodeficiency syndrome (AIDS) has strengthened the commitment of health care professionals to protect patient privacy. As a direct reflection of FDA's longstanding regulations and commitment to this policy, the agency's MEDWATCH form (and its predecessors) expressly states that the information identifying the patient and reporter is held in confidence (see 58 FR 31611 through 31612, June 3, 1993). However, in connection with FDA's current efforts to promote the MEDWATCH program and to increase reporting of serious adverse events, the health care community has voiced concerns about the agency's ability to safeguard confidentiality and protect the identities of the reporter and patient identified in the report, especially in situations where the report is in the possession of an individual manufacturer. Despite FDA's longstanding policy of keeping these identities confidential, the current concerns threaten to undermine the success of the voluntary reporting program. FDA published its draft uniform MEDWATCH form for reporting suspect adverse events and product problems on February 26, 1993 (58 FR 11768). Subsequently, the agency received several comments about FDA's ability to maintain the confidentiality of patient and reporter identities: (1) When the report of an adverse event is made directly to the manufacturer or (2) when the manufacturer receives the information from FDA after a report is made to the agency. The MEDWATCH form permits individuals reporting directly to the agency to indicate that they do not want their identity disclosed to the manufacturer. However, the agency encourages reporters to allow the agency to share the reporter's identity with the manufacturer in order to help FDA and the manufacturer conduct necessary followup. Currently, State and local laws govern disclosure of information from adverse event report forms that are in the possession of manufacturers, whether the reports come directly to the manufacturer from reporters or are relayed to manufacturers by FDA. Some State and local laws allow or require disclosure of identities of reporters and patients in adverse event reports. FDA believes that if the identities of reporters or patients were made public or available to third parties, health care professionals would be much more reluctant to submit voluntary adverse event reports for fear of involving themselves and their patients in litigation. It is well recognized that many physicians are concerned about the potential for involvement in litigation by their patients or third parties. In a 1992 survey of physicians regarding adverse event reporting, over 37 percent of the respondents agreed with the statement that reporting increases the risk of becoming involved in litigation; 18 percent of the respondents listed fear of becoming involved in the administrative or legal process as an important reason for not reporting adverse reactions (Ref. 7). Several other surveys have been conducted which asked physicians what factors influenced their decision not to report an adverse event (Refs. 8, 9, and 10). Between 8 and 14 percent of the respondents in the studies stated that concern over legal liability was one reason why they did not report an adverse event. Moreover, if the reporter is a health care professional, particularly a physician, the reporter may fear that disclosure of his or her identity would increase the chances that a patient's identity would be discovered, thus risking a breach of the confidential physician-patient relationship. In recent years FDA has learned of a number of product liability lawsuits in State courts in which manufacturers have been requested or ordered to provide the names of persons reporting adverse reactions to particular products. In some instances, the names of the affected patients have been requested. The manufacturers involved in these cases vigorously opposed discovery requests that sought the disclosure of patient and reporter identities. Occasionally, when the disclosure issue was being litigated, the manufacturers requested that FDA formally express its views on the disclosure of these identities and the effects such disclosure might have on the agency's postmarketing surveillance program. FDA firmly believes that the success of its postmarketing surveillance efforts is dependent upon protecting the confidentiality of individuals involved in adverse experience reports. Thus, FDA took the unusual step of becoming involved in a number of these cases by filing, with the assistance of the Department of Justice, a statement of the Federal government's interest. The statement informed the courts of the potential damage the agency believes would be done to its postmarketing surveillance program and the public health if the identities of patients and reporters were released to plaintiffs in these cases. The agency believes that its efforts have contributed to continued protection of reporter and patient identities in all the cases in which FDA has participated. III. The Need for Federal Regulation FDA has determined that in order to help assure beneficial and consistent reporting of adverse events to the agency's MEDWATCH program, State and local rules that would permit or require disclosure of the identities of reporters and patients named in the reports must be clearly preempted by FDA's amended regulation. Laws that permit disclosure of the identities of health professional reporters or patients identified in the reports directly interfere with FDA's ability to collect information required under sections 505(k) and 519 of the act (21 U.S.C. 355(k) and 360i). Section 505(k) requires manufacturers to submit information about approved drug products in order to enable FDA to monitor the safety of the product and ``facilitate a determination'' of whether the drug should be withdrawn from the market. This provision is implemented in Sec. 314.80 (21 CFR 314.80) of the FDA regulations, which establishes mandatory reporting requirements of adverse reactions for manufacturers of drugs. Section 519 of the act requires device manufacturers, distributors, importers, and user facilities to submit to FDA reports of certain adverse events to ensure the safety and effectiveness of devices. FDA has implemented this provision in regulations establishing mandatory reporting requirements for manufacturers, importers, and distributors (21 CFR part 803). FDA also has proposed regulations establishing reporting requirements for user facilities (see the Federal Register of November 26, 1991 (56 FR 60024)). Under section 351 of the Public Health Service Act (42 U.S.C. 262(d)), biological products are licensed in accordance with regulations ``designed to insure the continued safety, purity, and potency'' of these products. Under FDA's implementing regulations, a biological product license may be revoked if the product does not conform to applicable standards or is not safe and effective (21 CFR 601.5(b)). The agency's proposed biologics adverse experience reporting regulations would establish mandatory reporting requirements for manufacturers of most biological products (see the Federal Register of March 29, 1990 (55 FR 11611)). Although these reporting requirements are or will be mandatory for manufacturers, device distributors, and device user facilities, these required reports ultimately rely upon voluntary reporting by health professionals. Manufacturers cannot report adverse events if they do not find out about them from the health professionals who observed or were advised of the events. As stated in section II. of this document, disclosure of patient or reporter identities serves as a significant disincentive for voluntary reporting by health professionals. Preempting State and local disclosure laws and rules that permit or require such disclosure would remove a significant impediment to FDA's ability to implement postmarketing surveillance programs that are essential to the public health. Furthermore, sections 505(k) and 519 of the act provide that regulations and orders issued with respect to postmarketing reporting requirements ``shall have due regard for the professional ethics of the medical profession and the interests of patients * * *'' (21 U.S.C. 355(k) and 360i). The confidentiality of the physician-patient relationship is a basic tenet of medical ethics. The AMA Code of Ethics requires that, with certain limited exceptions, ``(t)he utmost effort and care must be taken to protect the confidentiality of all medical records'' (``1992 Code of Medical Ethics, Annotated Current Opinions,'' Section 5.07; and see the ``1991 Standards of Clinical Nursing Practice of the American Nursing Association''). The recent AMA opinion that physicians have an ethical obligation to report adverse drug or device events is likely to be incorporated in medical practice if confidentiality can be ensured (Ref. 11). FDA firmly believes that the public health interest in securing information from health professionals about potential hazards associated with marketed products far outweighs the interest an individual plaintiff may assert to obtain reporters' identities in private tort actions. FDA recognizes the sophistication and complexity of private tort litigation in the United States and the proposed preemption action is not intended to frustrate or impede tort litigation in this area. Indeed, FDA recognizes that product liability plays an important role in consumer protection. The proposed regulation has been drafted to permit any individual plaintiff who experienced an adverse event and subsequently has become involved in medical malpractice litigation with the person who reported the event to obtain all the information contained in the adverse event report. In this situation, where both parties to the litigation know each other's identities, the interests of the parties in protecting this information is minimized and, therefore, would not impose a significant disincentive to reporting. IV. Legal Authority for Federal Preemption A. Principles of Preemption Law Under the Supremacy Clause of the Constitution, State law may be preempted by Federal law in a number of ways (U.S. Const., Art. VI, cl. 2.). Congress may preempt State law by so stating in express terms (Jones v. Rath Packing Co., 430 U.S. 519 (1977)). Section 521 of the act contains an express preemption provision applicable to devices. Under that section, no State may establish a requirement for a device ``different from, or in addition to'' any requirement applicable to the device under the act relating to safety or effectiveness or other matter included in an applicable requirement. (See 21 CFR part 808; Commonwealth of Massachusetts v. Hayes, 691 F.2d 57 (1st Cir. 1982)). Even when Congress has not expressly preempted State law, congressional intent to preempt may be inferred in several ways. Preemption may be found ``where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress `left no room' for supplementary state regulation'' (Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 713 (1985), quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)), or where ``the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject'' (Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947); see Hines v. Davidowitz, 312 U.S. 52 (1941)). Another way the courts infer a congressional intent to preempt is by determining that State law actually conflicts with Federal law. The conflict may be demonstrated either when ``compliance with both federal and state [law] is a physical impossibility'' (Florida Lime and Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963)), or when State law ``stands as an obstacle to the accomplishment and execution of the full purpose and objectives of Congress'' (Hines v. Davidowitz, 312 U.S. at 67). State law is also preempted if it interferes with the methods by which a Federal law is designed to reach its goals. (See International Paper Co. v. Ouellette, 479 U.S. 481, 494 (1987); Michigan Canners & Freezers Ass'n v. Agricultural Marketing & Bargaining Bd., 467 U.S. 461, 477 (1984).) In addition to the various ways in which preemption may result from congressional action or intent, ```a federal agency acting within the scope of its congressionally delegated authority may preempt state regulation' and hence render unenforceable state or local laws that are otherwise not inconsistent with federal law'' (City of New York v. FCC, 486 U.S. 57, 63-64 (1988), (quoting Louisiana Public Service Comm'n v. FCC, 476 U.S. 355, 368-69 (1986))). Express congressional authorization for an agency to preempt State law is not needed and ``federal regulations have no less preemptive effect than federal statutes.'' (Fidelity Federal Savings and Loan Assn v. de la Cuesta, 458 U.S. 141, 153, 154 (1982)). When an agency's intent to preempt is clearly and unambiguously stated, the Court's inquiry will be whether the preemptive action is within the scope of that agency's delegated authority (Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 700 (1984); Fidelity Federal Savings, 458 U.S. at 154). If the agency's choice to preempt ``represents a reasonable accommodation of conflicting policies that were committed to the agency's care by statute [the regulation will stand unless] it appears from statute or its legislative history that the accommodation is not one that Congress would have sanctioned'' (United States v. Shimer, 367 U.S. 374, 383 (1961)). In Hillsborough County, the Court stated that FDA possessed the authority to promulgate regulations preempting local laws that compromise the supply of plasma and could do so (Hillsborough County, 471 U.S. at 721). FDA believes it has similar authority to preempt local rules that compromise adverse reporting systems that are essential to postmarketing surveillance and protection of the public health. B. Conflicts Between State Disclosure Laws and Federal Law The conflicts between State and local disclosure laws and Federal law on reporting of adverse events justify FDA's preemption of these laws. Although Congress did not expressly preempt State law in this area, the agency's action is appropriate because State and local laws significantly interfere with the methods by which the Federal law is designed to achieve its goals. FDA is the Government agency charged with protecting citizens by helping to ensure that medical products, including human drugs, biologics, and devices, are safe and effective for their intended uses. To further this purpose, Congress established elaborate mechanisms for the Federal government to permit marketing of new drugs, biologics, and devices and to monitor the safety of these products after approval (21 U.S.C. 355(k) and 360; 42 U.S.C. 262). Pursuant to these statutory provisions, FDA has established an extensive regulatory scheme to monitor the safety and effectiveness of new human drugs, biologics, and devices (Secs. 310.305, 314.80, and Secs. 803.1 through 803.36). State and local rules of civil procedure, rules of evidence, and other laws and regulations that permit discovery of the reporters' and patients' identities are an obstacle to accomplishing this goal. Moreover, with respect to devices, such laws, regulations, and rules are different from the confidentiality requirements under the act and FDA regulations that implement adverse event reporting under section 519 of the act. Although reporter identities in voluntary adverse event reports contained in FDA records are not subject to discovery in State litigation, those reports that are in the possession of the manufacturer may be subject to State or local disclosure laws. The possibility of such disclosure will chill the willingness of reporters to share information with FDA, which may share details about a report with a manufacturer in order to investigate the report further. Preemption of State and local disclosure laws will remove an inhibiting influence on health professionals and will increase adverse event reporting. FDA has determined that such increased reporting outweighs the individual needs of plaintiffs to obtain information about the reporters and subjects of adverse reaction reports that are not about the plaintiff. The proposed regulation is narrowly drawn and focuses solely on protecting the identity of the reporter and patient and other individuals identified in the report. This proposed rule does not preempt State and local laws that require disclosure of the substance of adverse event reports. The agency does not believe that disclosure of the substance of the adverse event reports will impede its ability to collect this information. Indeed, FDA routinely releases the full substance of all voluntary adverse event reports to requestors after deletion of patient, reporter, and institution identities (Sec. 20.111(c)(3)(iii)). Nor will the regulation impede the ability of an individual plaintiff to obtain specific information about reports concerning his or her own reaction to a product when that plaintiff is involved in a medical malpractice lawsuit and a court grants discovery of records directly concerning the plaintiff. V. Summary of the Proposed Rule FDA's rule to preempt State and local laws, rules, regulations or other requirements that would permit the disclosure of the identity of health care professionals who report adverse events associated with FDA regulated products and the identity of patients and other individuals named in those reports would be codified in newly proposed Sec. 20.63(f). Proposed Sec. 20.63(f) would provide that the names and any identifying information, including the address of the reporter or the name or address of the institution, that would lead to the identification of the reporter or the persons named in a voluntary adverse event report, shall not be disclosed by either FDA or a manufacturer in possession of such report in response to any request. Proposed Sec. 20.63(f)(1) would provide exceptions to the prohibition of disclosing the names if both the reporter and the person identified in the adverse event report consent to disclosure of their identities, or if there is a court order in a medical malpractice action involving both the person named in the report and the reporter. Proposed Sec. 20.63(f)(1)(iii) would permit disclosure of an adverse event report to the individual who is the subject of the report upon request. Proposed Sec. 20.63(f)(2) explicitly states that no State or local entity shall establish or continue in effect any law, rule, regulation or other requirement that permits or requires the disclosure of the identities of the reporter or person identified in an adverse event report except as provided in this rule. VI. Executive Order 12612: Federalism FDA has examined the effects of this proposal on the relationship between the Federal Government and the States, as required by Executive Order 12612 on ``Federalism.'' The agency concludes that preemption of State or local rules that permit disclosure of the identities of the voluntary reporter or persons identified in an adverse event report for human drugs, biologics, and devices is consistent with this Executive Order. Executive Order 12612 recognizes that Federal action limiting the discretion of State and local governments is appropriate ``where constitutional authority for the action is clear and certain and the national activity is necessitated by the presence of a problem of national scope (section 3(b)). The constitutional basis for FDA's authority to regulate the safety and efficacy of human drugs, biologics, and devices is beyond challenge. Congress' decision to vest FDA with the responsibility to establish a regulatory scheme to monitor the safety of these products demonstrates Congress' view that the safety of human drugs, biologics, and devices is a problem of national scope (21 U.S.C. 355(k) and 42 U.S.C. 262)). Executive Order 12612 expressly contemplates preemption where there is a conflict of State and Federal authority under Federal statute (section 4(a)). State and local rules of civil procedure, rules of evidence, and other rules and regulations that permit or require disclosure of the identities of those who report adverse events associated with human drugs, biologics, and devices are an obstacle to fulfilling FDA's charge to monitor the safety and efficacy of these products. The guarantee of confidentiality of the reporters' and patients' identities is necessary to assure meaningful reporting of adverse events. In addition, Congress specified that Federal regulations issued to monitor the safety of drug products ``shall have due regard for the professional ethics of the medical profession and the interests of patients'' (21 U.S.C. 355(k) and 360i). State and local rules and regulations that permit disclosure of the identities conflict with this requirement by jeopardizing confidentiality and the physician-patient relationship. Executive Order 12612 requires that any Federal preemption be restricted to the minimum level necessary to achieve the objectives of the statute pursuant to which the regulations are promulgated (section 4(c)). The proposed regulation is narrowly drawn and focuses solely on protecting the identity of the reporter and patient and other individuals named in the report. The proposed rule does not preempt State and local laws that require disclosure of the substance of the adverse event reports. As required by the Executive Order, States will be given, through this notice of proposed rulemaking, an opportunity to participate in the proceedings to preempt State and local laws (section 4(e)). In addition, pursuant to the Order, the appropriate officials and organizations representing the States will be consulted before this proposed action is implemented (section 3(a)). The agency concludes that the policy proposed in this document has been assessed in light of the principles, criteria, and requirements in Executive Order 12612; that this policy is not inconsistent with that Order; that this policy will not impose additional costs or burdens on the States; and that this policy will not affect the States' ability to discharge traditional State governmental functions. VII. Economic Impact FDA has considered the economic impact of this proposed rule and concludes that it would impose no additional costs on industry or the general public. The value to an individual litigant of having the identities of reporters and subjects of adverse experiences is difficult to estimate; however, litigants will have available the substance of adverse experience reports, which is of greater importance. Although tort litigation could provide substantial economic benefit to an individual litigant, the net gain to health care and public health through efficient and complete reporting of serious adverse reactions greatly outweighs any damage an individual litigant may suffer from lack of access to the names of patients or reporters who are not parties in the litigant's lawsuit. Accordingly, FDA concludes that this proposed rule is not significant as defined by Executive Order 12866 and certifies that this proposed rule would not have a substantial economic effect on a significant number of small entities which would require a regulatory flexibility analysis under the requirements of the Regulatory Flexibility Act of 1980. VIII. Environmental Impact The agency has determined under 21 CFR 25.24(a)(8) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IX. References The following references have been placed on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Beard, K., ``Adverse reactions as a cause of hospital admissions in the aged,'' Drugs & Aging, 2:356-367, 1992. 2. Scott, H. D., S. E. Rosenbaum, W. J. Waters, et al., ``Rhode Island physicians recognition and reporting of adverse drug reactions,'' Rhode Island Medical Journal, 70:311-316, 1987. 3. Griffin, J. P., and J. C. P. Weber, ``Voluntary systems of adverse reaction reporting: Part II,'' Adverse Drug Reactions and Acute Poisoning Reviews, 1:23-55, 1986. 4. Koch, K. E., ``Adverse Drug Reactions,'' in The Handbook of Institutional Pharmacy Practice, 3d ed., edited by Brown, T., Bethesda, MD, American Society of Hospital Pharmacists, pp. 279-291, 1992. 5. Practice Standards of the American Society of Hospital Pharmacists, 1992-1993. 6. Joint Commission on Accreditation of Healthcare Organizations, Accreditation Manual, Chicago, IL, 1993. 7. Mathematics Policy Research, ``American Medical Association Survey of Physicians Regarding Adverse Event Reporting,'' October, 1992. 8. Milstein, J., G. Faich, J. P. Hsu, et al., ``Factors affecting physician reporting of adverse drug reactions,'' Drug Information Journal, 20:157-164, 1986. 9. Scott, H., S. Rosenbaum, W. Waters, et al., ``Rhode Island physicians' recognition and reporting of adverse drug reactions,'' Rhode Island Medical Journal, 70:311-316, 1987. 10. Juergens, J., and B. Banahan, ``Adverse drug reaction reporting by Mississippi physicians,'' Journal of the Mississippi State Medical Association, 2:33-37, 1986. 11. 1993 AMA Council on Ethical and Judicial Affairs Opinion Memorandum. X. Request for Comments Interested persons may, on or before March 28, 1994, submit to Dockets Management Branch (address above) written comments regarding this proposal. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects in 21 CFR Part 20 Confidential business information, Courts, Freedom of information, Government employees. Therefore under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 20 be amended as follows: PART 20--PUBLIC INFORMATION 1. The authority citation for 21 CFR part 20 continues to read as follows: Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321-393); secs. 301, 302, 303, 307, 310, 311, 351, 352, 354-360F, 361, 362, 1701-1706, 2101 of the Public Health Service Act (42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1); 5 U.S.C. 552; 18 U.S.C. 1905. 2. Section 20.63 is amended by adding new paragraph (f) to read as follows: Sec. 20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy. * * * * * (f) The names and any information that would identify the voluntary reporter or any other person named in any adverse event report associated with a human drug, biologic, or medical device product shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request. Information that would identify the voluntary reporter or persons identified in the report includes, but is not limited to, the name, address, institution, or any other information that would lead to the identities of the reporter or person identified in a report. This provision does not affect disclosure of the identities of reporters required by statute or regulation to make adverse event reports. Disclosure of the identities of such reporters is governed by the applicable statutes and regulations. (1) Exceptions. (i) Identities may be disclosed if both the voluntary reporter and the person identified in an adverse event report or that person's legal representative consent in writing to disclosure; or (ii) Identities may be disclosed pursuant to a court order in the course of medical malpractice litigation involving both the person who experienced the reported adverse event and the voluntary reporter; or (iii) The report shall be disclosed to the individual who is the subject of the report upon request. (2) Preemption. No State or local governing entity shall establish or continue in effect any law, rule, regulation or other requirement that permits or requires disclosure of the identities of the voluntary reporter or other person identified in an adverse event report except as provided in this section. Dated: January 21, 1994. Michael R. Taylor, Deputy Commissioner for Policy. [FR Doc. 94-1640 Filed 1-21-94; 4:50 pm] BILLING CODE 4160-01-P