[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]



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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.

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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 

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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