Law Law 6842-01  Fall 2009
American Health Care Law
Professor Vernellia R. Randall
The University of Dayton School of Law


Internet Pharmaceutical Communications
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Unit 1 - Organization                                    x
Unit 2 -  Access                                  x
Unit 3 - Quality                                            x
Unit 4 - Disparities and  Reform                             x
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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to pharmaceutical Internet promotions in the future, the agency offers little guidance to manufacturers, apart from draft guidance dealing with the relatively minor issue of the placement of product names, size, and prominence.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.


17: Promoting Quality                                          x
18 Regulation of Professionals                                     x
19 Regulation of Instituions                                      x
21 - Liability - Professionals                                      x
23: Liability - Hospitals                                 x
24 - Liability - Managed Care                              x
26 Confidentiality                                                     x
27 Informed Consent                                          x






Related Pages:
Home ] Up ] Pharmaceutical Dispensing in the "Wild West" ] Responsive Regulation ] Regulation of Online Pharmacies ] Safety as an Element of Quality ] [ Internet Pharmaceutical Communications ]
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Previous Pages:
Home ] Lesson 18: Regulation of Professionals ] Lesson 19: Regulation - Institutions ] Lesson 20: Regulation of Pharmaceuticals ] Lesson 21: Liability -Professional ] Lesson 22: Liability - Professionals- II ] Lesson 23: Liability - Institutions - Part I ] Lesson 24: Liability - Institutions - Managed Care ] Lesson 25: Reforming the Tort System ] Lesson 26 Contract/ Confidentiality ] Lesson 27: Relationship - Informed Consent ]
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Professor Vernellia R. Randall
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