FDA tries to accommodate free speech

After losing a series of court decisions that found it violated the American First Amendment free speech guarantees, the U.S. Food and Drug Administration has begun a wide-ranging review of regulations that control what the makers of drugs, supplements, food and cosmetics can say about their products.

At issue is the balance between a company's right to communicate with its customers and the agency's mandate to protect the public.

Some of the issues involved come down to what a drug company can print on a T-shirt or what a sales agent can say in the privacy of a doctor's office.

Or whether food companies can make health claims for their products.

Some of the agency's critics claim the review is long overdue and that FDA personnel need sensitivity training on First Amendment issues.

In April, the U.S. Supreme Court ruled that the FDA's requirement that pharmacies making specialized mixtures of prescription drugs must seek new drug approvals before they can advertise or promote their products is a violation of their free speech rights.

Similarly, in 1998, a federal district court overturned FDA regulations preventing companies from distributing information about unapproved uses for approved drugs and devices. Another ruling, in 1999, overturned the FDA's refusal to allow dietary supplement makers to put health claims on their labels.

Source: Gina Kolata, Stung By Courts, FDA Rethinks Its Rules, New York Times, October 15, 2002.

For text http://www.nytimes.com/2002/10/15/health/policy/15FDA.html

For more on FDA Reform http://www.ncpa.org/iss/hea

FMF Policy Bulletin\15 October 2002