In The News October 1999

Encore!
The FDA Suffers Another Legal Defeat

The FDA's nine-year string of losses in the Federal Courts continues unabated. In a First Amendment lawsuit filed by the Washington Legal Foundation, a U.S. District Court ruled that drug makers can give doctors copies of published medical studies that highlight the use of their drugs for diseases not approved by the Food and Drug Administration. The FDA had sought to severely restrict drug companies from doing that.

This July 28, 1999 ruling gives pharmaceutical companies the ability to promote drugs for unapproved uses. The Life Extension Foundation has been battling for the right to promote approved drugs for unapproved uses for more than 15 years. The Foundation's position is that the FDA should not be allowed to suppress the dissemination of information that appears in peer-reviewed scientific journals. While this is considered a major victory for drug companies, it's also great news for American citizens who may now learn more quickly about innovative therapies that could be used to save their lives.

U.S. District Judge Royce Lamberth ruled that the Food and Drug Modernization Act illegally restricts the free speech of drug companies. He termed government arguments defending the limits "preposterous." Under the judge's ruling, the studies the companies provide to doctors cannot be false or misleading and drug company salespeople must disclose any association between the company and researcher. Further, the company must disclose whether the treatment detailed in the studies are FDA approved.

The FDA wanted the authority to review (i.e. censor) published studies before companies could give them to doctors. Regulators also wanted the power to require drug makers to give doctors additional studies on the drug. And, the FDA wanted companies to only distribute studies of drugs when the firms were already in the federal review process for the additional uses. The Court made it clear that censorship of free speech will not be tolerated.

Peggy Dotzel, FDA acting associate commissioner for policy, said the agency was studying the ruling in order to prepare an appropriate response. Shawn Gunnarson of the Washington Legal Foundation, the conservative group that had challenged the law, was pleased with the ruling. "It makes it very clear that the First Amendment is alive and well."

As long-time members of The Life Extension Foundation know, the FDA has previously filed criminal indictments against Foundation leaders William Faloon and Saul Kent alleging that they committed "criminal acts" by promoting both approved and unapproved drugs for "unapproved uses." While these criminal indictments were eventually dismissed by the government, the fact that the FDA is willing to jail its political opponents sends a chilling message to pioneering doctors and scientists who are seeking to make major medical advances available to dying Americans.

This ruling represents a major victory for the free speech provisions of the First Amendment and against FDA censorship. The Foundation, however, wants to caution its members that some drugs will be promoted to doctors that may not be safe and effective. Life Extension magazine will do its best to alert members about dangerous drugs that should be avoided, but the bottom line continues to be, "patient beware."