The Food and Drug Administration and medroxyprogesterone acetate. What are the issues?
A. Rosenfield, D. Maine, R. Rochat, J. Shelton and R. A. Hatcher
In 1978, the Food and Drug Administration denied approval of the
three-month injectable contraceptive depot medroxyprogesterone acetate for
use in the United States. This decision goes against the advice of the
FDA's own scientific advisory panels, as well as the rulings of the World
Health Organization and the drug regulation institutions of more than 70
developed and developing countries. In response to protest from the
manufacturer of depot medroxyprogesterone acetate and from many health
professionals, the FDA took the unusual step of scheduling a public board
of inquiry to review its decision in January 1983. Reviewing the scientific
literature on the risks and benefits of depot medroxyprogesterone acetate,
we find no reason to deny depot medroxyprogesterone acetate approval,
provided that studies of its possible side effects are continued and that
women use it only after having made an informed choice between this and
other methods of contraception.
