FDA Internet Regulation? Public Comment Accepted until December 16

On October 16 and 17 the FDA held a public meeting, "FDA and the Internet: Advertising and Promotion of Medical Products," near Washington D.C.; several hundred people attended, mostly from industry (apparently there were no more than two AIDS community or activist representatives). This meeting has been widely reported in the press, but these articles did not tell their readers that anyone can submit written comments until December 16.

Background about the meeting was published in the Federal Register, September 16, volume 61, number 180, pages 48707-48710. That Federal Register notice included the following summary:

"The Food and Drug Administration (FDA) is announcing a public meeting to discuss issues related to the promotion of FDA-regulated medical products on the Internet. FDA is seeking participation in the public meeting and written comments from all interested parties, including, but not limited to, consumers, patient groups, information vendors, manufacturers of FDA-regulated medical products, and health care professionals. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of biologics, human and animal drugs, and medical devices on the Internet and the World Wide Web (the Web)."

The meeting was divided into five discussion groups: Investigational product information; Chatrooms and newsgroups; Additional regulatory issues; Website links; and International issues.

A complete transcript of the two-day meeting is available on the FDA Web page, http://www.fda.gov.

How to Submit Comments

"Submit written comments on the questions to the Dockets Management Branch (DMB) (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. After the meeting, a transcript will be available at DMB (address above) between 9 a.m. and 4 p.m., Monday through Friday."

We suggest that persons preparing comments examine the meeting transcript, available either worldwide through the Web or at the FDA's Rockville office, or at least read the Federal Register announcement of the meeting, which includes the FDA's specific questions for each discussion group.

Comment

From what we have heard after the meeting, it seems unlikely that the FDA will make major attempts to regulate the content of medical information on the Internet -- but there is no way to know for sure. We are concerned about a number of issues, for example:

* Pharmaceutical and other companies may be pressured to restrict more of their material to medical professionals -- rolling back the movement toward patient empowerment (some online material is already restricted). Also, requiring registration as medical professionals could greatly limit information flow to developing countries, even to medical professionals, because doctors there would probably not show up as licensed in the databases in the U.S. or other home country of the pharmaceutical company.

* Even aside from Internet issues, restriction of information about experimental drugs has greatly hindered recruitment in clinical trials. Why will doctors refer patients, if they do not understand the rationale of the treatment or the trial (which companies are often afraid to include in their trial announcements, lest they be accused of promotion)? The main problem is not in the FDA's intent, nor in the regulations themselves, but in overreaction by industry personnel who do not know the system very well, and are overly fearful of getting their companies, and therefore their own careers, in trouble. Formal regulations, or even informal standards and expectations, could inadvertently extend and exacerbate this problem, unless great care is used.

* The rapidly developing "global village" world has both advantages and disadvantages; one of the advantages is a kind of world medicine built on local traditions. There have long been much greater differences internationally in medical care (even between seemingly comparable industrialized countries) than the public realizes. Traditionally, if the medicine of one's own country does not work for a patient's condition, that patient is out of luck. But with world medicine, the locally approved treatments will still be tried first, because physicians are most familiar with them; but when local drugs or procedures are unsuccessful, others can be borrowed from countries which have different approved protocols, drugs, indications, and diagnostic tests -- increasing the overall chance of a successful outcome. Today, individual educated patients and activist movements are at the leading edge of this change; as world medicine develops, it will need to become more institutionalized in order to serve more people. But clearly the benefits of world medicine are seriously threatened either by medical uniformity imposed everywhere, or by blocking information about drugs and indications in those countries where they are not approved.