[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Notices]
[Pages 24314-24316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12022]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0227]


Direct-to-Consumer Promotion

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a notice 
making clear that the agency does not require preclearance of 
prescription product promotion (advertising and promotional labeling) 
of human or animal drugs, biologics, or restricted medical devices 
directed toward consumers. FDA is also requesting comments on its 
intent to consider certain FDA-approved patient labeling as adequate to 
fulfill the brief summary requirement in consumer-directed 
advertisements. Finally, FDA is soliciting comments concerning several 
issues related to consumer-directed promotion of prescription 
biologics, human and animal drugs, and restricted medical devices to 
help guide policy decisions.
DATES: Written comments by August 12, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Nancy M. Ostrove, Division of Drug 
Marketing, Advertising and Communications (HFD-40), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, rm. 17-B04, Rockville, MD 20857, 301-827-2828, or via Internet at 
O[email protected].
SUPPLEMENTARY INFORMATION:

I. Background

    Under the Federal Food, Drug, and Cosmetic Act (act) and the Public 
Health Service Act, the Food and Drug Administration (FDA) has 
responsibility for regulating the labeling and advertising of 
prescription drugs (animal and human), biologics, and restricted 
medical devices. Labeling and advertising must follow certain 
requirements, as defined by the Act and implementing regulations.
    Under section 502(n)of the act (21 U.S.C. 352(n)), an advertisement 
for a prescription drug must contain, in addition to the product's 
established name and quantitative composition, ``such other information 
in brief summary relating to side effects, contraindications, and 
effectiveness * * *.'' This requirement is further defined in 
prescription drug advertising regulations at Sec. 202.1(e) (21 CFR 
202.1(e)). Under section 502(r) of the act (21 U.S.C. 352(r)), an 
advertisement for a restricted medical device must contain, in addition 
to the established name, ``a brief statement of the intended uses of 
the device and relevant warnings, precautions, side effects, and 
contraindications * * *.''
    The act and FDA's advertising regulations do not distinguish 
between targeted audiences. FDA recognizes, however, that there are 
differences between the information needs of health care professionals 
and consumers resulting from differences in medical and pharmaceutical 
expertise, and differences in roles as potential recipients of 
medications or prescribers of medications, that may affect their 
perceptions, comprehension, and interpretation of promotional claims. 
In light of these differences, FDA is continuing to evaluate its 
policies and regulations.
    In the Federal Register of August 16, 1995 (60 FR 42581), FDA 
announced a part 15 (21 CFR part 15) hearing to be held on October 18 
and 19, 1995. In that document, the agency solicited oral testimony and 
written responses to a series of questions concerning direct-to-
consumer (DTC) promotion of prescription drugs. At the hearing, the 
agency heard testimony from representatives of consumer and patient 
groups, advertising associations, and foreign governments, as well as 
from individual academicians, attorneys, marketers, and pharmaceutical 
manufacturers. The agency accepted written comments until December 29, 
1995. FDA is currently evaluating the testimony, comments, and issues 
raised by both the public hearing and citizen petitions submitted prior 
to the hearing.
    While this evaluation proceeds, FDA is providing clarification of 
two of its policies and soliciting additional information to help in 
the development of overall policy. FDA views these efforts as part of a 
comprehensive process designed to encourage meaningful communication to 
consumers about prescription drugs, biologics, and restricted medical 
devices, while continuing to help ensure that consumers are adequately 
protected from false, misleading or otherwise violative promotion.

II. Preclearance

    One issue raised in oral testimony, written comments, and citizen 
petitions was an objection to the perceived requirement for 
manufacturers to obtain prior clearance from the agency for all 
prescription drug and biological DTC promotion. There is, in fact, no 
such requirement. Given public and congressional concern since the 
early 1980's about prescription drug DTC promotion, together with the 
inexperience of the pharmaceutical industry in producing DTC 
advertising, FDA had informally requested manufacturers to submit, on a 
voluntary basis, proposed DTC promotional

[[Page 24315]]

labeling and advertising for review and comment prior to use. See 
Sec. 202.1(j)(4), which provides that ``any advertisement may be 
submitted to the Food and Drug Administration prior to publication for 
comment.''
    FDA wishes to clarify that it has never required preclearance of 
consumer-directed prescription drug promotion, or advertising for 
restricted devices. Under sections 502(n) and 502(r) of the act, FDA 
may require prior approval of prescription drug and medical device 
advertisements only in ``extraordinary circumstances.'' (See, e.g., 
Sec. 202.1(j)(1)--prior approval will be required when a sponsor or FDA 
receives information, not widely publicized in medical literature, that 
a drug may cause fatalities or serious injuries, and despite 
notification from FDA, the sponsor fails to publicize adequately such 
information.)
    FDA believes that industry's desire for agency guidance on proposed 
DTC promotion and applicable regulatory requirements, and the cost of 
developing corrective materials or campaigns explains the high rate of 
submission of DTC promotional materials for prior review and comment. 
However, it appears that the agency's request that manufacturers 
voluntarily obtain advice on proposed DTC materials has been 
misinterpreted as a requirement. FDA reiterates that it does not now 
require, nor has it ever required, manufacturers to submit DTC 
promotional labeling and advertising for preclearance. \1\
---------------------------------------------------------------------------

    \1\ This does not apply to submissions required in a premarket 
notification submission or premarket approval application (PMA) 
under 21 CFR 807.87(e) and 814.20(b)(10) or submissions required in 
connection with accelerated approval under 21 CFR 314.550 and 
601.45.
---------------------------------------------------------------------------

III. Patient Labeling in Fulfillment of the ``Brief Summary'' 
Requirement

    FDA recognizes that many consumers do not have the technical 
background to understand fully the information typically included in 
prescription drug and biological advertisements to fulfill the ``brief 
summary'' requirement. To meet the ``brief summary'' requirement, 
sponsors typically reprint, in small type, whole sections of the 
professional labeling, which is generally written in terms that are not 
easily understood by the average consumer.
    Some prescription drugs and biological products have FDA-approved 
labeling, in addition to that written for health professionals, that 
contains information intended to be understandable to patients. This 
patient labeling contains information that comprehensively, although 
not exhaustively, describes the safety and efficacy of the product. 
Although it is less comprehensive than professional labeling, patient 
labeling is intended to provide patients prescribed the medication with 
information that will help them use their medication effectively and 
safely. It should also, therefore, provide potential users with 
appropriately written product information they may want to consider.
    FDA believes that such FDA-approved patient labeling generally 
meets the brief summary requirements, and, because it is written for 
patients, is a more appropriate vehicle for communicating risk 
information to consumers than the technically-written brief summary. 
FDA is requesting comment on its intention to consider the reprinting 
of certain FDA-approved patient labeling as adequate to fulfill the 
brief summary requirement in consumer-directed advertisements for 
prescription drug and biological products. The following products offer 
prototypical examples of such comprehensive patient labeling: Oral 
contraceptives, estrogenic products, Cardura, 
Fosamax, Glucophage, Hytrin, 
Proscar, Seldane, and Ticlid.
    Not all FDA-approved patient labeling, however, generally meets the 
brief summary requirements. Some approved patient labeling primarily is 
intended to give instructions for use (e.g., directions on how to use 
medications delivered via inhalation, nasal spray, patch, or 
injection). Other patient labeling focuses primarily on a single 
warning (e.g., Accutane , the class auxiliary warning labels 
on angiotensin-converting-enzyme (ACE) inhibitors and isoproterenol 
inhalers). In both of these instances, the patient labeling has a 
narrow focus that is not intended to offer comprehensive risk 
information to patients. Because of this narrow focus, such patient 
labeling would not generally meet the brief summary requirements and 
would not be considered acceptable consumer brief summaries.
    FDA also notes that many manufacturers have voluntarily produced 
informational brochures and other product-specific materials for 
patients that are disseminated through various outlets. These materials 
are typically submitted to the agency either for prior review and 
comment, or through the postmarketing review process specified in 21 
CFR 314.81(b)(3)(i). Such materials that have not been through the 
formal labeling review process should not be considered automatically 
acceptable as a consumer brief summary. Instead, they may be used as 
brief summaries only if they fulfill all of the applicable requirements 
in Sec. 202.1(e).

IV. Requests for Comments on Other Issues

    Many complex public health issues are raised by DTC promotion. In 
the August 16, 1995, Federal Register document, FDA solicited broad 
public comment on the major issues concerning DTC promotion and whether 
the agency's current regulatory approach should be modified. Some of 
these issues were specifically addressed in testimony and written 
comments. These raised additional questions, about which FDA is now 
soliciting public comment.
    1. -Currently, Sec. 202.1(e) states that the brief summary shall 
include information relating to side effects, warnings, precautions, 
contraindications, and other risk information. In print advertising, 
this requirement is generally fulfilled by including the risk-related 
sections of the approved labeling in, or adjacent to, the 
advertisement. For advertisements broadcast through media such as 
radio, television, and telephone communications systems, 
Sec. 202.1(e)(1) provides that the advertisement ``shall include 
information relating to the major side effects and contraindications of 
the advertised drugs in the audio or audio and visual parts of the 
presentation and unless adequate provision is made for dissemination of 
the approved or permitted package labeling in connection with the 
broadcast presentation shall contain a brief summary of all necessary 
information related to side effects and contraindications.''
    In addition, section 502(r) of the act requires that advertisements 
for restricted devices contain a brief statement of the intended uses 
of the device and relevant warnings, precautions, side effects, and 
contraindications.
    Much testimony, petitions, and comments questioned the usefulness, 
for consumers, of the existing ``brief summary'' of risk information 
that results from application of these requirements. Many comments 
contended that, for consumer advertising, a shorter, more focused 
presentation of user-friendly information could meet the statutory 
requirement and also provide appropriate risk-related information. Some 
comments suggested that a consumer brief summary should include 
``information relating to the major side effects and 
contraindications'' of the product, as currently required in 
prescription drug and biological product

[[Page 24316]]

broadcast advertising. (This information has colloquially been referred 
to as the ``major statement.'')
    If FDA required or permitted more limited risk information in place 
of the current brief summary, what specific information should be 
included? What criteria should be used by manufacturers and the agency 
to identify the ``major'' risk information for any particular product? 
FDA is also interested in empirical research that specifically 
addresses the issues of how much and what kind of risk information can 
and should be communicated in DTC advertising of prescription drug and 
biological products.
    2. Some comments suggested that risk information could be 
communicated to consumers through standardized general disclosures. 
This kind of disclosure would not reference particular characteristics 
of a product. Instead, such statements would reference one or more 
general risks, such as the fact that all prescription drug and 
biological products have side effects; that they are only available 
from a physician or other prescribing health care professional; that 
they have significant benefits, but may have significant risks; that 
patients should discuss product risks with a physician, etc.
    Such disclosures, however, are susceptible to habituation or 
``wear-out,'' which results in the viewer quickly learning to ignore 
the message, thus lowering its effectiveness. In addition, such 
messages may not be perceived as risk messages at all, but instead 
interpreted as reassurances. If the latter is the case, these messages 
would not fulfill the purpose of the brief summary requirement, which 
helps ensure that advertising conveys a balanced impression about the 
product's benefits and risks.
    FDA solicits comments on the effectiveness of such standardized 
general disclosures at transmitting risk information. FDA is especially 
interested in any research that addresses the issue of the 
effectiveness of general risk disclosures of the type described above.
    3. Promotional materials appear in very different media that each 
have distinctive characteristics (e.g., print, broadcast, telephone 
communications, facsimile, Internet). Should FDA require or permit 
different disclosures for consumer-directed promotion of prescription 
drug and biological products that appears in different media, to 
reflect the capabilities of these varying media, or should the 
disclosure be the same regardless of medium? For example, should print 
media contain longer and more complete information than broadcast media 
because such information could be made readily available at minimal 
cost and because consumers of print media may be more willing, able, 
and/or desirous of obtaining more complete information?
    4. Different products have different degrees of effectiveness. In 
some cases, a product that works for a relatively small percentage of 
the appropriate patient population is approved either because it is the 
only available therapy for a condition; because all other therapies for 
the condition also have only modest benefits; or because it has 
relatively few risks. Should FDA require the communication of the 
degree of product effectiveness in DTC promotion? How could this 
information be communicated most effectively?
    5. It has been suggested that toll-free telephone numbers are one 
way that product sponsors could make required information available to 
audiences. FDA requests comments and information from consumers, health 
professionals, product sponsors and other interested individuals 
regarding: (a) How useful toll-free numbers are as a mechanism for 
obtaining or disseminating information about medical products, and (b) 
the costs to a sponsor of using toll-free numbers as a means of 
disseminating information.
    FDA welcomes comments on all of the issues described above and 
especially invites the submission of relevant empirical research.

    Dated: May 8, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-12022 Filed 5-13-96; 8:45 am]
BILLING CODE 4160-01-F