Timing of FDA Plan B announcement questioned

Aug 2 2006

The Center for Reproductive Rights issued the following statement from Nancy Northup, president of the Center for Reproductive Rights, in response to the FDA announcement regarding Plan B.

The timing of the FDA's announcement is highly suspect given the mounting pressure of two significant hearings involving the agency: tomorrow's Senate confirmation hearing of Dr. Andrew C. von Eschenbach; and a scheduled hearing on Thursday, August 3rd, by the Center for Reproductive Rights regarding its request to subpoena documents from the White House in its Tummino v. von Eschenbach lawsuit.

A recent deposition of a senior FDA official by the Center for Reproductive Rights indicates the White House was exerting influence on the FDA regarding Plan B in order to "appease the administration's constituents." That admission was one of the bases of our decision to request the White House subpoena, however, the government has now asked that the subpoena hearing be postponed.

While we hope the FDA has finally decided to stop playing politics with Plan B, we remain skeptical, especially given the new requirements the FDA is placing on Barr Pharmaceuticals in order to obtain approval. We believe that by imposing these additional hurdles the FDA will continue to violate the Constitutional rights of women in need of emergency contraception. We will push ahead with our request to subpoena the White House and continue to vigorously pursue our case against the FDA.

It is time for the FDA to make Plan B available to the millions of women who wish to use a drug that has been proven scientifically safe and effective. If the FDA continues to refuse to do their job, we will use the courts to do it for them.

Ms. Annie Tummino, lead plaintiff in the Center's case said, "While we hope that this latest move by the FDA will actually make the morning-after pill available without a prescription, the proposal of an age limit of 18 is completely outrageous. There is simply no medical reason for it."