Health Policy

Contrary to the opinions expressed by Dr. Henry I. Miller in Commentary (Dec. 12), science, the law and sound public-health policy considerations continue to determine the decisions made by the Food and Drug Administration.

And, in fact, those were the reasons for the approval of the female condom. At the time of approval, the agency clearly stated its scientific analysis and underlined the limitations of the female condom for preventing pregnancy and protecting against sexually transmitted diseases.

The agency also stated that, in an era of AIDS, it was important to provide women with the means to protect themselves without depending on the cooperation of their partners.

Simply stated, the decision was based on science, the law and public-health concerns; and that is also the case in biotechnology where the agency continues to follow the policy announced in May, 1992.

A thorough scientific review of the approval for (the milk-stimulating drug, bovine somatotropin) rBST was appropriate, especially in light of the concerns voiced in many quarters. This review has enabled the agency to defend strongly and appropriately its decision.

If Miller wants to venture from the realm of opinion into the world of facts, he needs to do his homework.

JAMES A. O’HARA III

Associate Commissioner

for Public Affairs

Department of Health & Human Services

Rockville, Md.