3TC and Protease Inhibitors: Citizen's Petition Asks Faster Approval



Log Cabin Republicans, a gay and lesbian Republican
organization, has formally petitioned the FDA to speed
approval of three drugs -- 3TC, saquinavir, and MK-639. The
petition states that it should be possible to approve 3TC by
September 1995, saquinavir by November 1995, and MK 639 by
May 1996; this is well ahead of the expected timetable, in
which approval for 3TC, for example, is not expected until
winter 1996 -- a time frame everyone agrees is too long.

The petition also explores the possibility of approving
critical drugs even earlier, as soon as they are ready for
expanded access.

The FDA is required to respond to a formal petition, and
David Feigal of the FDA met with petitioners on March 28 to
discuss practical obstacles to approval, and means of
speeding the process.

Note: A similar petition, seeking more rapid approval of ddI
and ddC, was filed with the FDA in December 1990; it may have
contributed to the FDA's relatively rapid approval of ddI.