FDA Issues Draft Guidance on the Internet and Social Media
On January 10, 2014, the Food and Drug Administration (FDA)
issued a Draft Guidance entitled "Fulfilling Regulatory
Requirements for Postmarketing Submissions of Interactive
Promotional Media for Prescription Human and Animal Drugs and
Biologics." This Draft Guidance concerns how and when industry
should provide information to the FDA concerning content on product
websites, firm blogs discussion boards, chat rooms, or other public
electronic forums (e.g., Twitter) and social networking sites
(e.g., Facebook).
The FDA recognizes two types of labeling for drugs: 1)
FDA-required labeling; and 2) "promotional labeling."
According to the Draft Guidance, promotional labeling is generally
any labeling, other than FDA-required labeling, devised for
promotion of the product. To constitute labeling, the content need
not accompany the product. Virtually any utterance attributable to
a company can be considered labeling for compliance and enforcement
purposes. The term "interactive promotional media"
includes "modern tools and technologies that often allow for
real-time communications and interactions (e.g., blogs, microblogs,
social networking sites, online communities, and live podcasts)
that firms use to promote their drugs." What remains unclear
is what content on any interactive promotional media concerning a
product would not be "labeling."
The Food Drug and Cosmetic Act (FDCA) addresses promotion that is
"carried out by the firm itself, and to promotion conducted on
the firm's behalf." In determining whether the firm is
accountable for a communication about its products, the FDA looks
to "whether the firm or anyone acting on its behalf is
influencing or controlling the product promotional activity or
communication in whole or part." Firms may have various
options for how much control they exert over activities that
utilize interactive promotional media, regardless of whether the
promotional activity occurs on firm-sponsored or third-party
venues. The FDA considers firms responsible for content on the
internet as follows:
1. Sponsored Sites: A firm is responsible for product
promotional communications on sites that are owned, controlled,
created, influenced, or operated by, or on behalf of the
firm.
2. Third–Party Sites: A firm may be responsible for
"promotion" on third-party sites
"if the firm has any control or influence on the third-party
site, even if that influence is limited in scope." Control and
influence are defined as collaboration or editorial control
(including preview or review privileges). Financial support is not
enough to create reporting requirements.
3. Employees and Agents: Content generated by an employee
or agent who is "acting on behalf of the firm to promote the
firm's product" creates a reporting obligation.
The FDA considers a firm responsible for blogger's sites where
the "blogger is acting on behalf of the firm." The FDA
provides an example:
A sales representative acting on behalf of a firm posts
comments about the innovative release mechanism of the firm's
product on an independent third-party site. Because the sales
representative is acting on behalf of the firm, the firm is
responsible for submitting the comments to FDA to meet the
postmarketing submission requirements.
The FDA will not consider a firm responsible for user-generated
content that is "truly independent of the firm (i.e., is not
produced by, or on behalf of, or prompted by the firm in any
particular)."
Submitting Interactive "Promotional Media"
FDA recognizes the challenges of submitting promotional materials
that display real-time information and provides five suggestions
for submitting information to facilitate FDA review:
1. Sponsored Sites: At the time of initial display, a firm should
submit in its entirety all sites for which it is responsible,
including annotations to describe the parts that are interactive
and allow for real-time communications.
2. Third-Party Sites: submit the home page of the third-party
site, along with the interactive page within the third-party site
and the firm's first communication.
3. Monthly: submit an updated listing of all sites for which it is
responsible.
4. Restricted Access Sites: submit all content related to the
discussion (e.g., all user generated content)
5. When submitting the site, FDA recommends that a firm take
formatting factors (e.g., appearance, layout, visual impression)
into consideration.
The Draft Guidance applies to "manufacturers, packers, and
distributors... that may either be the applicant or acting on
behalf of the applicant, of prescription human and animal drug and
biological products (drugs)."
In November 2013, FDA issued Draft Guidance concerning Advertising
and Promotional Labeling (here). While that Draft Guidance concerns
"promotional labeling," neither the regulations nor the
statue itself defines the term. Thus, what FDA is purporting to
regulate in the current Draft Guidance is vague and subject to
determination by the agency. Whether such vagueness will survive
constitutional scrutiny, particularly under recent Supreme Court
and Circuit Court decisions refusing to defer or seriously
questioning agency interpretations of vague rules, remains to be
seen.
On July 9, 2012, President Obama signed into law the Food and Drug
Administration Safety and Innovation Act (FDASIA), giving the FDA
until July 2014 to "issue guidance that describes FDA policy
regarding the promotion, using the internet (including social
media), of medical products... ." In its Draft Guidance, FDA
acknowledges that regulating how firms use the internet (or
interactive media) has been unsettled for many years and references
hearings it held in 2009 on this issue. The FDA has been looking at
industry use of the internet and social media for product promotion
since the advent of the internet. An entire generation of Americans
has been raised on the internet and rules remain lacking. In
FDA's defense, technology is a moving target and new media
continues to evolve and revolutionize how society behaves and
shares information. Clarity is still sorely lacking on the most
important aspects of how FDA intends to regulate the conduct of
manufacturers in the internet age. As industry awaits FDA's
Guidance regarding the promotion of medical products using the
internet and social media, this Draft Guidance is a significant
step forward in providing a road map on how to comply.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
