Christianity: Zero different than the Taliban.

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November 14, 2005

F.D.A.'s Rejection of Contraceptive Is Questioned

By MARIA NEWMAN

The Food and Drug Administration did not follow its usual procedures in
rejecting an application for over-the-counter sales of the emergency
contraceptive pill Plan B, the investigating arm of Congress found today.

The General Accounting Office also said in its 57-page report that there
were questions about whether top officials of the F.D.A. made the decision
to reject the application for over-the-counter sales of the drug, which is
opposed by some religious conservatives, even before its own advisory
committee had issued its recommendation on the matter.

Several legislators and scientists have complained that the F.D.A. was
putting politics ahead of science in its handling of the contraceptive,
which can be used as emergency, morning-after contraception.

The G.A.O. said in its report that "the Plan B decision was not typical of
the other 67 proposed" changes from prescription to over-the-counter sales
that the agency received from 1994 through 2004.

The agency, which was charged with examining how the decision to reject
the

application was made, and how it compared to the decisions of other
requested changes from prescription to over-the-counter sales, does not
make recommendations about what action the F.D.A. or Congress should make
in the matter.

But critics of the decision used the report as the basis to ask that the
F.D.A. decision be revisited.

"We are deeply opposed to this subversion of science," Representative
Henry

Waxman, Democrat of California, wrote to Health and Human Services
Secretary Mike Leavitt, in a letter signed by 17 other lawmakers.

They urged Mr. Leavitt, who oversees the F.D.A., to intervene to assure
that a pending reconsideration of the pill's status "is based on the best
available science instead of ideology."

In May 2004, the F.D.A. rejected an application by Barr Laboratories to
sell its Plan B contraceptive over the counter without restrictions,
saying

the company's studies did not include enough girls younger than 16.

This came after the agency's own nonprescription drugs advisory committee
and its review staff recommended approval.

Last month, a consultant to that advisory panel, Dr. Frank Davidoff,
editor

emeritus of the Annals of Internal Medicine, resigned in protest of the
agency's handling of the Plan B contraceptive, saying it was putting
politics over science. In August, the top women's health official at
agency, Susan Wood, also quit in protest over the Plan B decisions.

The G.A.O. report suggested that top F.D.A. officials had discussed
turning

down the application for over-the-counter sales of Plan B as early as
December 2003, even though its advisory panels had not yet weighed in.

It also said that in Barr's application to switch Plan B from prescription
to over the counter sales, or O.T.C,, as the agency calls it, "F.D.A.'s
high level management was more involved in the review of Plan B than in
those of other O.T.C. switch applications."

In its response to the G.A.O.'s draft report, Jane Woodcock, deputy
commissioner for operations at the F.D.A., said it was "inaccurate" to
suggest that a decision had already been made to reject the application
before the review committees weighed in. She said, however, that "it was
entirely normal" for top officials "to convey to the review division their
concerns regarding the application."

She also said the Plan B case had attracted a high level of "public
interest," including two citizen petitions. Top level officials were
involved in the review process, she said, but only to the extent that it
was "typical for high-profile, controversial applications."