[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

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.


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 
    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 
    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 
    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 
    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 

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, 
    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, 
    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 

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:


    1. The authority citation for 21 CFR part 20 continues to read as 

    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. 

    2. Section 20.63 is amended by adding new paragraph (f) to read as 

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; 
    (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]