BILL INTRODUCED TO HAVE FDA REVISIT “MORNING-AFTER PILL” DECISION

May 17, 2004
Press Release

WASHINGTON, DC - A week after the Food and Drug Administration (FDA) decided to deny over-the-counter (OTC) status for the Plan B® contraceptive - the“Morning-After Pill” - Reps. Carolyn Maloney (NY-14), Joseph Crowley (NY-07) and 15 colleagues introduced a bill in Congress today that would direct the FDA to revisit the decision (PDF of bill). Under the legislation, the FDA would review its decision and would have to affirm that the decision was not based on politics, was based on science and conformed to FDA precedent and procedures. The FDA has drawn heavy criticism for ignoring its own scientific advisory panel, which voted 23-4 to recommend OTC status.

“If the FDA’s decision wasn’t politically-influenced, this bill should be a no-brainer,” said Maloney. “Assuming that this was a scientific decision, why would anyone shy away confirming exactly that? Americans need to know how our government is making decisions about the public health. Just as we expect to see a doctor, not a lobbyist, when we go to the doctor’s office, we should expect our pubic health decisions to be made by scientific experts, not interest groups.”

"Emergency contraception meets the criteria that other over-the-counter drugs have had to meet,” said Crowley. “This has been proven time and again and even recommended by the FDA. And yet here we are, again fighting against extremist politics, fighting for the experts to be heard. We are fighting for women’s interests to be protected. It is time for the FDA to put health policy above politics."

The bill is currently co-sponsored by: Rep. Carolyn B. Maloney, Rep. Joseph Crowley, Rep. Christopher Shays, Rep. John Conyers, Rep. Jesse Jackson, Jr., Rep. Lois Capps, Rep. Juanita Millender- McDonald, Rep. Tom Lantos, Rep. Sheila Jackson-Lee, Rep. Lynn Woolsey, Rep. Jerrold Nadler, Rep. Bob Filner, Rep. Jan Schakowsky, Rep. Barney Frank, Rep. Barbara Lee, Rep. Rosa DeLauro, Rep. Raúl M. Grijalva.

Summary of legislation:
30 days after enactment of the legislation, the FDA Commissioner would have to review his prior decision on Plan B® and affirm 1) that his decision was not politically influenced, 2) that it was based on sound science, and 3) that it conformed to FDA precedent and procedures. He must affirm these items, under penalty of law.

Facts about Emergency Contraceptive Pill (ECP):
Plan B® does not cause abortion, but instead prevents pregnancy if taken shortly after unprotected sex. The pill prevents inhibits ovulation, fertilization or implantation. If taken within 24 hours of unprotected sex, it can prevent 95% of pregnancies, or 89% if taken within 72 hours.

Nearly half of pregnancies in the United States are unintended, a number that could be cut in half with over-the-counter emergency contraceptive pills (ECPs). They are also expected to have a significant impact on health care costs - the New York State Comptroller recently released a report stating that the state of New York could trim nearly half a billion dollars from its health care expenditures if ECPs were widely available.

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