FDA Allows AIDS Patients to Import Banned Drugs

The head of the Food and Drug Administration said Saturday that the agency has begun allowing AIDS patients to import treatment drugs that have not been approved for sale in the United States.

Speaking to a hostile crowd at a conference on gay and lesbian health issues, FDA Commissioner Dr. Frank E. Young unexpectedly announced that the government last Wednesday officially began to allow the import of some unapproved treatments for acquired immune deficiency syndrome.

“All of us are dealing with a time line that is fierce,” Young told a crowd of about 300 who heckled him throughout his speech.

Under the terms of the new policy, AIDS patients can import drugs from other countries if the product is purchased for personal use and not for sale, Young said.

Explains Policy Change

Young said the FDA was moved to change its policy in part to control the shipment of AIDS treatments because some drugs have been imported illegally.

He said some of the drugs have been shown to have applications to help combat the disease, which is caused by a virus that damages the immune system, leaving victims susceptible to infections and cancer.

Young defended the FDA’s record, saying the agency had worked hard to gain approval for the drug AZT, which federal government scientists consider the most promising treatment developed to date to prolong the lives of those with the virus. He said that federal money and personnel devoted to AIDS have increased dramatically.

Despite the announcement, protesters charged the government with failing to do enough to permit the use of drugs for AIDS victims.

“He announced the policy because he heard there were going to be protests and he wanted to placate us,” said Debbie Levine of the New York-based AIDS Coalition to Unleash Power.

Alarms Ringing

The demonstrators, most of the crowd attending the speech at the 10th National Lesbian and Gay Health Conference and AIDS Forum, held aloft watches with alarms ringing to illustrate that people with AIDS cannot wait while drugs are put through years of testing before use.

Levine said several drug treatments for AIDS being used in Europe, Japan and elsewhere have been proved to be effective and should be legalized in the United States.

Young said he wanted the meeting at the conference to mark the beginning of an effort to “build bridges” between federal regulators and AIDS activists.

“The FDA shares your concern for the individuals who are suffering from this devastating disease and (is) painfully aware of their desperate efforts to seek treatment,” Young said over protesters’ shouts, which often drowned out his speech.

As of June 15, the FDA had approved 178 applications for testing of drugs and other therapies to treat AIDS, Young said.