[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.
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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]
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