FDA advised not to stifle Internet with burdensome regulation
by Michael Evers From Natural Healthline |
My personal view is that paternalism may have had a place 40 years ago when Congress empowered FDA to regulate what medical product companies could say and do, but it no longer holds today. The Internet is making global communication a reality and governments are going to find it increasingly difficult to control what companies say and do within and beyond their borders. The FDA panelists may not have liked what I said: none of them smiled or nodded agreement. But surely they must feel frustrated as their ability to control communication slips away.
And I wasn't alone in urging caution as speaker after speaker during the two-day meeting, which concluded today, echoed similar concerns. More than 400 people packed the Silver Spring, Maryland hotel to provide the Food and Drug Administration input as it grapples with the impact of the Internet and how companies are using it to promote products around the globe.
The meeting was actually a continuation of a series of meetings the agency has been having with companies for more than a year. Pharmaceutical companies and device manufacturers have moved cautiously onto the Internet as they seek guidance from the FDA and other regulatory agencies. Because the Internet presents new challenges for the agency, and is international in scope, FDA assembled five panels of specialists from around the world to engage in moderated discussions aimed at exploring various regulatory issues in detail. Written comments will be accepted until December 16, 1996, and the agency will produce draft guidelines shortly thereafter.
Speaker after speaker implored the agency not to "stifle innovation with regulation" with the notable exception of Public Citizen's Sidney Wolfe, MD. Wolfe and his colleagues are opposed to direct-to-consumer advertising by medical product companies and they urged FDA to curb it with new regulations.
Fraud and unfair practices was a theme presented by representatives from the Federal Trade Commission. FTC's Lee Peeler reminded the assembly that you "can't have an information superhighway without having super highwaymen."
Similar concerns were raised by a representative of the National Association of Attorneys General. Ricardo Hicks, Executive Deputy Attorney General of Pennsylvania, said 39 state AGs are "aggressively" looking into the Internet and they are coordinating and working closely with the Securities and Exchange Commission, the Justice Department, the Secret Service, the Federal Trade Commission and, of course, the FDA.
Actually, FDA has been quite restrained this past year, talking privately with companies and consultants as it tries to figure what to make of this Internet phenomena. And Bob Temple, director of the Office of Drug Evaluation, acknowledged that the agency is not interested in what independent parties do on the Internet. Its focus right now is on what regulated companies are placing on the Internet and the links to and from those sites. Of chief concern is the promotion of unapproved uses for approved drugs and devices, otherwise known as "off-label."
The complete transcript of the meeting will be available in a few weeks on FDA's Web site.
Acupuncture.com |