Your editorial ("No Need for Separate Testing," March 19) misses the point of my proposal for state tests and state licensing of the French abortion pill RU 486.
The main reason there's been no application from the manufacturer, and no license from the manufacturer to an American company, is because of the hostile regulatory climate at the Food and Drug Administration. That's why the California Medical Assn. unanimously condemned "non-medical political pressure" as the reason for the unavailability of RU 486 in the United States.
The issue is not so much the need for additional testing of a drug that has already been studied--though further tests may well be required to fully establish its safety. The issue is taking the necessary steps to make RU 486 available to American women who choose to use it. That is not likely to happen unless there's a positive regulatory climate which both encourages applications and promises decisions made on medical merits, rather than political pressure. That's the point of my proposal.
Your statement that the FDA has handled its responsibilities "in an impressive fashion" misstates the facts. It was because of the FDA's notoriously slow, almost obstructionist, approach to testing experimental AIDS drugs that I sponsored legislation in 1987 to create a state process for testing and approval. It has worked well, both on its own terms and as a spur to faster action by the FDA.
Dr. Marcus Conant of San Francisco, one of the investigators of the AIDS vaccine developed by Dr. Jonas Salk, estimates that using the California process cut as much as two years off the time the FDA would have taken to approve the Salk vaccine for testing. Avoiding a similar delay--or a much longer one--in the testing, approval and potential sale of RU 486 is an additional very significant reason for California testing.
Finally, the editorial is wrong on two other points: California isn't the only state that exercises authority to test drugs independently from the FDA. Moreover, I've never suggested that state funds earmarked for testing AIDS-related drugs be used to test RU 486. Such tests could be funded through private sources, the existing Health Services budget, or new funds.
California women have a right of privacy, including reproductive choice, independent of any federal constitutional or statutory provisions. California should be a leader in protecting that right, without having to rely on the actions of a federal bureaucracy subject to the vagaries of political pressures.
JOHN K. VAN DE KAMP