A House subcommittee was urged yesterday to permit the contraceptive Depo Provera to be shipped abroad, even though the Food and Drug Administration has not approved its use by American women.
Dr. Fred Sai of Ghana told the census and population subcommittee that African women have had difficulty using other methods of birth control. He said Depo Provera, a progestin hormone administered by injection once every three months, has been effective in preventing pregnancies.Like the pill, it prevents ovulation.
The Food, Drug and Cosmetic Act prohibits exportation of drugs that have not been approved by the FDA. But the House is considering a bill that would permit the United States to ship such drugs if other countries said they they needed them and that they were aware of the risks.
Donald Kennedy, commissioner of the FDA, testified that the agency did not approve the drug because of a potential risk of breast cancer. He cited studies on beagles indicating that the drug causes an increase in benign and malignant breast tumors in that species.
He said the FDA did not know whether the occurrence of breast cancer in dogs could be extrapolated to humans.
"Nevertheless," Kennedy said, "the bureau views the drug as posing a significant potential risk to humans. No contraceptives currently approved for marketing have shown a similar carcinogenie potential in the beagle."
The FDA decided in March not to approve Depo Provera for use by U.S. women. But the Unjohn Co., the only firm in the United States that manufactures the drug, asked the FDA to hold a hearing on its decision. The hearing is to take place in September. The FDA is expected to make another decision on whether to approve the drug in October.
Kennedy testified that other countries should make their own decisions on whether to use the drug, based on each country's availability of alternatives and religious beliefs or traditions.
"A decision about the appropriateness of a contreceptive drug for the U.S. should not necessarily apply to any other nation, let alone all," he said.