Second FDA Adviser Resigns Over Plan B Handling

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FDA Adviser Resigns Over Plan B Handling

October 7, 2005

WASHINGTON (AP) -- A consultant to a Food and Drug

Administration advisory panel has resigned in protest

of the agency's handling of the Plan B contraceptive.

Dr. off, editor emeritus of the ls of

Internal Medicine, said the agency is ignoring science

in favor of politics in delaying approval of the drug

for over-the-counter sales.

He was a member of the FDA's Nonprescription Drugs

Advisory Committee when it voted to approve Plan B for

over-the-counter sales in 2003, and had served as a

consultant to the committee since his term ended

earlier this year.

off is the second person to publicly resign over

Plan B. In late August, the top women's health

official at FDA, Wood, also resigned in protest.

Former FDA Commissioner Lester Crawford has also since

resigned.

Plan B, which can be used as emergency, morning-after

contraception, is opposed by some religious

conservatives.

The committee off was on is one of several

scientific advisory committees that provide the FDA

with an independent assessment of new drugs.

off resigned in September after the agency

announced it was indefinitely postponing a decision to

allow over-the-counter sales of the drug, despite

recommendations from scientists that it is safe.

FDA rejected the recommendation, citing concern about

young teens' use of the pills without a doctor's

guidance. Manufacturer Barr reapplied but Crawford

announced in August that any decision was on hold.

" There wasn't any observable scientific or procedural

reason for them to first decline and then further

delay the decision. I had to make the inference this

was a decision that was made on the basis of political

pressure, and it seemed to me that was unacceptable, "

off, of Wethersfield, Conn, said in a telephone

interview.

Copyright 2005 The Associated Press. All rights

reserved.