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Emile L. Loza
FDA Regulation of Internet Pharmaceutical Communications: Strategies
For Improvement
Excerpted from: Emile L. Loza, FDA'S CURRENT POSITION
ON PHARMACEUTICAL INTERNET, 55 Food and Drug Law Journal 269, 273 (2000)
Although FDA may speak to pharmaceutical Internet promotions in the
future, the agency offers little guidance to manufacturers, apart from
draft guidance dealing with the relatively minor issue of the placement
of product names, size, and prominence. Further, the agency carries no
Internet item on the Department of Health and Human Services (DHHS)
Unified Agenda. Further, while regulation of Internet drug sites
qualifies for Level 1 guidance as an "unusually complex ... or
highly controversial issue," FDA has not incorporated Internet
issues into its Good Guidance Practices and indeed seems to deviate from
its own policy of restricting its communication of policy matters to
these Practices documents.
Despite its recognition that the industry was "screaming for
guidance" and its 1996 public meetings on the subject, FDA has not
prioritized the need for regulatory clarification in the Internet
context. The agency states that its light-handed approach *274 will
minimize any stifling of the creative potential of this new technology.
While FDA agrees that manufacturers have hesitated to use the Internet
in the absence of its guidance, it sees this reticence fading as
manufacturers forge ahead on their own. Perhaps this is so, but at what
risk to consumers?
FDA has given little official feedback to drug manufacturers that
have moved ahead to populate the Internet. By mid-1997, FDA had issued
only three untitled letters and no warning letters to drug manufacturers
about their Internet promotions.
The agency does not resolve the fundamental question of whether
Internet sites constitute advertising or labeling. The agency itself
appears to have internal conflicts about this classification question.
FDA states that the requirements are essentially the same regardless of
the classification, but does not indicate which regulations control
Internet communication. The agency has held this view for at least four
years, leaving it to the manufacturers to choose which regulations apply
to their Internet sites. Manufacturers, however, likely regard a
labeling classification as key to their learned intermediary defense.
The agency treats Internet promotions of pharmaceutical drugs
similarly to those delivered by print, broadcast, and other media. FDA
indicates that its current requirements for these other media should be
sufficient to guide the manufacturer. Further, FDA intends to provide
guidance only in areas unique to the Internet.
One unique aspect of the Internet medium is "hyperlinks."
Hyperlinks on drug sites present serious compliance issues related to
pre- approval promotion and the promotion *275 of "off-label"
uses. In Washington Legal Foundation v. Friedman, the court forbade FDA
from restricting disclosure of such information, e.g., through journal
articles that refer to off-label uses, on First Amendment grounds. Given
this decision, the Supreme Court's recent support of commercial free
speech, and FDA's concern about the distribution of product materials by
nonsubsidiary healthcare organizations or pharmacy benefits management
companies, how hyperlinks will be treated by the agency is far from
settled. FDA indicates that it will apply fair balance requirements to
hyperlinks, but has declined to discuss the matter in detail.
Another unique aspect of the Internet is its fluid and continual
transcendence of national borders and time zones. If information is the
new currency, the Internet is the Euro on an ISDN line. The Internet's
ubiquity brings to the fore questions involving access to information
about uses that are approved elsewhere in the world, but not by FDA.
Here, FDA likewise is silent officially, but unofficially the agency
seeks to limit access to information on prescription drug uses in other
countries. The agency disfavors any mention of uses in other countries,
even when such mentions are accompanied by disclaimers clarifying the
lack of FDA approval status and distinguished by country flag graphics.
FDA had indicated that it likely would release Internet guidance by
summer 1997 and, then, by late 1997. Yet, the Internet continues
conspicuously to be absent from the agency's Agenda. The agency declines
to provide a date or approximate time frame as to when an overview of
its planned agency-wide hyperlink policy, guidance documents, or any
such information may be available. |
