New FDA drug approval policies and HIV vaccine development.

The need for new drugs to treat AIDS has caused the federal Food and Drug Administration to modify its procedures for reviewing and approving investigational drugs. Even researchers with reservations about the FDA's new policies are receptive to the idea that the drug review process in the United States could be improved, and the same may be true for the procedures by which vaccines are reviewed. Mariner explains why, because of the differences between drugs and vaccines, the FDA's new drug review policies should not be applied to investigational vaccines to prevent HIV infection. Experimental vaccines warrant separate treatment to protect the healthy subjects who receive them. Mariner argues that the FDA should make an explicit decision to continue to review candidate HIV vaccines in its vaccine unit, separately from drugs, with stricter standards of safety and efficacy.