Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules

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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