[Federal Register Volume 60, Number 156 (Monday, August 14, 1995)]
[Notices]
[Pages 41891-41893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19947]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0228]
Pharmaceutical Marketing and Information Exchange in Managed Care
Environments; Public Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing regarding pharmaceutical marketing and information exchange in
managed care environments. FDA is seeking information and views
concerning the potential impact of
[[Page 41892]]
changing organizational structures and information dissemination
channels in the managed care setting on the agency's responsibilities
to regulate drug marketing and promotion. The agency is particularly
interested in exploring the issues surrounding new modes and techniques
of drug information dissemination (e.g., the communication of cost-
effectiveness claims) and the formation of alliances between
manufacturers and prescription benefit management companies (PBM's).
DATES: The public hearing will be held on October 19, 1995, from 1:30
p.m. to 5:30 p.m., and October 20, 1995, from 8:30 a.m. to 5:30 p.m.
Submit written notices of participation by September 15, 1995. Written
comments will be accepted until December 29, 1995.
ADDRESSES: The public hearing will be held at the Quality Hotel-Silver
Spring, 8727 Colesville Rd., Silver Spring, MD 20910. Submit written
notices of participation and comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with docket number 95N-0228. Transcripts of the hearing will
be available for review at the Dockets Management Branch (address
above).
FOR FURTHER INFORMATION CONTACT: Lee L. Zwanziger, Center for Drug
Evaluation and Research (HFD-9), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4695.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Federal Food, Drug, and Cosmetic Act, FDA has
responsibility for regulating the labeling and advertising of
prescription drugs. Specifically, the agency reviews promotional
materials disseminated by, or on behalf of, prescription drug
manufacturers for consistency with approved drug product labeling, and
to ensure that these materials are accurate, contain proper
disclosures, and ``fair balance'' in terms of benefit and risk
information. Underlying this responsibility is a public health concern
that health care professionals and patients base their decisions about
drug products on sound scientific data and information.
Traditionally, health care providers, patients, pharmacists, and
pharmaceutical manufacturers have been separate entities with
independent functions. However, the relationships among health care
providers, pharmaceutical manufacturers, and health benefits managers
are changing. The rapid growth of managed health care, with its
emphasis on managing the quality of care while controlling costs, has
dramatically changed pharmaceutical purchasing. Consequently,
pharmaceutical marketing has also changed to emphasize value in
addition to safety and effectiveness. Direct comparative effectiveness,
safety, and cost-effectiveness information has become more prevalent as
a basis for promotional claims.
Furthermore, the audience for prescription drug promotion has also
changed. The importance of institutional decisionmakers as recipients
of marketing communications has increased. Over the past several
months, several pharmaceutical manufacturers have formed business
relationships with or have purchased companies that manage pharmacy
benefits (i.e., PBM's). FDA has received reports that these entities
are disseminating information to formulary decisionmakers, prescribers,
and users about the allied manufacturer's drug products. Moreover,
pharmacist employees of certain PBM's have telephoned prescribers to
request that they switch their patients to the drug products of their
employer's allied manufacturer.
Several pharmaceutical manufacturers have approached FDA about its
policies regarding the dissemination of pharmacoeconomic information,
especially comparative cost-effectiveness analyses of pharmaceutical
products. In response to these inquiries, FDA has stated that
``effectiveness'' elements of cost-effectiveness claims must be based
on adequate and well-controlled studies and cost elements should be
substantiated by adequate disclosure of both prices and methods used to
derive the cost estimates. In addition, the Division of Drug Marketing,
Advertising and Communications (DDMAC) has circulated a draft set of
principles for use in evaluating pharmacoeconomic claims.
Some have asserted that the dissemination of information by the
pharmaceutical industry to managed care providers (e.g., formulary
managers) need not meet traditional standards of substantiation because
the audience is highly educated and able to regulate the process by
creating a demand for supporting studies that display scientific rigor.
In addition, they maintain that these audiences may impose
corrective measures (e.g., formulary exclusions), which would drive up
the quality of pharmacoeconomic analyses. However, the proponents also
suggest that the increased costs and time needed to conduct multiple
studies with sufficient methodological rigor are prohibitive and that
their customers are demanding information that, in some instances, may
only be provided by the use of less expensive techniques such as
administrative data base analysis and modeling.
The agency recognizes that these issues affect both the
manufacturers' desire to provide drug information and the managed
health care industry's need for this information. Accordingly, FDA
seeks to investigate the implications of these issues on its regulatory
responsibilities.
II. Scope of the Hearing
In light of the many complex scientific and public health issues
raised by the evolution of the health care environment, FDA is
soliciting broad public participation and comment on the potential
implications of these changes on pharmaceutical regulation. The agency
encourages individuals with information relevant to these changes to
respond to this notice. FDA is interested in a broad range of issues
including:
(1) Changing business relationships. What are the implications of
the changing health care market on pharmaceutical communications and
promotion? Should FDA regulations be modified? If yes, how should the
agency's regulations be modified? How would these modifications affect
FDA's public health responsibilities?
(2) Changing marketing claims. How are pharmacoeconomic claims
different from traditional comparative claims between therapeutically
similar drugs or therapies? What should be FDA's goal in monitoring
cost-effectiveness claims? What level of support is necessary to
substantiate cost-effectiveness claims?
(3) Changing audiences for industry-supplied pharmaceutical
information. Who is receiving/asking for industry-supplied
pharmaceutical information? Is this audience more sophisticated (highly
educated) than traditional audiences? What type of comparative
information is sought? How is this comparative information utilized and
interpreted? What should be FDA's goal in monitoring the communication
of comparative drug information to healthcare providers and patients
within managed care organizations?
(4) Changing channels for communication of pharmaceutical
information. What constitutes sufficient evidence of ``independence''
to give
[[Page 41893]]
confidence of unbiased decisions in formulary development? How can FDA
protect scientific-exchange between the pharmaceutical company and the
target audience while protecting the audience from false and misleading
pharmaceutical promotion? How should FDA address methods employed by
pharmaceutical manufacturers to ``switch'' patients from one drug
therapy to another similar product? How should FDA address
communications from the PBM's to the target audience? What specific
types of information and services do managed health care organizations
commonly request from the pharmaceutical industry? Examples of such
services may include provider/patient education or formulary
coordination between organizations (``pull-through'').
III. Notice of Hearing under 21 CFR Part 15
The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
presiding officer will be the Commissioner of Food and Drugs or his
designee. The presiding officer will be accompanied by a panel of
Public Health Service employees with relevant expertise.
Persons who wish to participate in the part 15 hearing must file a
written notice of participation with the Dockets Management Branch
(address above) by September 15, 1995. To ensure timely handling, any
outer envelope should be clearly marked with docket number 95N-0228 and
the statement ``Pharmaceutical Marketing and Information Exchange in
Managed Care Environments.'' Groups should submit two copies of
materials. The notice of participation should contain the speaker's
name, address, telephone number, affiliation, if any, brief summary of
the presentation, and approximate amount of time requested for the
presentation. The agency requests that interested persons and groups
having similar interests consolidate their comments and present them
through a single representative. FDA will allocate the time available
for the hearing among the persons who file notices of participation as
described above. If time permits, FDA may allow interested persons
attending the hearing who did not submit a written notice of
participation in advance to make an oral presentation at the conclusion
of the hearing.
After reviewing the notices of participation and accompanying
information, FDA will schedule each appearance and notify each
participant by telephone of the time allotted to the person and the
approximate time the person's oral presentation is scheduled to begin.
The hearing schedule will be available at the hearing. After the
hearing, the hearing schedule will be placed on file in the Dockets
Management Branch under docket number 95N-0228.
Under Sec. 15.30(f) (21 CFR 15.30(f)), the hearing is informal and
the rules of evidence do not apply. The presiding officer and any panel
members may question any person during or at the conclusion of their
presentation. No other person attending the hearing may question a
person making a presentation or interrupt the presentation of a
participant.
Public hearings under part 15 are subject to FDA's guideline (21
CFR part 10, subpart C) concerning the policy and procedures for
electronic media coverage of FDA's public administrative proceedings.
Under Sec. 10.205, representatives of the electronic media may be
permitted, subject to certain limitations, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
required by Sec. 15.30(b). Orders for copies of the transcript can be
placed at the meeting or through the Dockets Management Branch (address
above).
Any handicapped person requiring special accommodations in order to
attend the hearing should direct those needs to the contact person
listed above.
To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of those provisions as specified in
Sec. 15.30(h).
To permit time for all interested persons to submit data,
information, or views on this subject, the administrative record of the
hearing will remain open following the hearing until December 29, 1995.
Dated: August 7, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-19947 Filed 8-11-95; 8:45 am]
BILLING CODE 4160-01-F