FDA Nomination Stalled Over Emergency Contraceptive Issue

by Cynthia L. Cooper

(WE) NEW YORK -- Annie Tummino of Brooklyn scrambled to find a morning-after pill, worried that an interruption in her birth control routine might have put her at risk of unintended pregnancy after having sex with her boyfriend. "I realized I was in trouble," said Tummino.

Available by prescription, Plan B, high-dosage progestin birth control pills, is emergency contraception that can prevent the establishment of a pregnancy if taken soon after intercourse.

Best results occur within 24 hours; good results within three days to five days. With her doctor's office closed, Tummino searched the Internet and lucked out, finding a hotline in New York that helped her get a prescription.

"I was so thankful," she said. "All women should be able to get the morning-after pill this easily, so none of us ever has to panic," said Tummino.

But not everyone agrees. The Food and Drug Administration is currently withholding a decision on a drug company's latest application to allow Plan B to be sold over the counter. In the meantime different states are leaving women around the country with a patchwork of access regulations.

In March, New Jersey became the seventh state to permit pharmacists to provide the product after a consultation at the drugstore, but without a prescription.

This "behind-the-counter" access is already available in Alaska, California, Hawaii, Maine, New Mexico and Washington State. Similar legislation is proceeding favorably in New Hampshire, but was rejected this year in Maryland.

Now, a storm is brewing over the nomination of acting commissioner Dr. Lester Crawford to the top position at the FDA. fter meeting with Crawford, Democratic Senators Patty Murray of Washington and Hillary Clinton of New York have put a "hold" on his nomination to commissioner until the agency under his watch issues a decision on the past-due application for direct sales of Plan B to consumers in drugstores.

Plan B maker Barr Laboratories filed the second application in July. The FDA had a target date of January by which to issue a ruling. (By law, the FDA must meet a high percentage of these targets.) The first application to sell Plan B over the counter was denied on grounds that it might be inappropriate for younger teens.

To move over-the-counter access forward, Barr Laboratories' current application limits drug store sales to anyone 16 and over.

"The FDA continues to drag its feet," Murray said after she and Clinton met with Crawford. "They have jeopardized public confidence and the health of American women. This is too important a decision to be endlessly delayed for ideological reasons."

"The bottom line is that the FDA has had the Plan B application for years and the American people simply need an answer yes or no," said Clinton.

Both senators are members of the Health, Education, Labor and Pensions Committee, which was scheduled to hold a confirmation hearing on Crawford's nomination on April 13.

The senators have put a hold on the committee's confirmation vote, which will prevent a full vote in the Senate. The FDA declined to comment on the senators' statements.

The FDA denied Barr Laboratories' first application in May 2004 in a move that came as a surprise to many because the application had received overwhelmingly favorable votes by two scientific review committees.

Seven months later, the New York-based Center for Reproductive Rights went to court to pressure the FDA to release Plan B for over-the-counter sale.

In the suit, the reproductive-rights organization charged the FDA with failing to follow its own procedures in the first Barr application. Even if the current Barr application is approved, the lawsuit will continue because it seeks expanded access to all individuals, including those under 16.

Activists, such as Tummino, also organized the Morning After Pill Conspiracy and are generating petition signatures demanding access to the product.

Unlike Mifeprex or RU-486, the so-called abortion pill, Plan B is designed as a last-stop measure to prevent the establishment of a pregnancy, as its name indicates.

Some of those who oppose Plan B nonetheless argue that Plan B is, by their terms, the same as abortion.

The American Life League, an anti-abortion and anti-contraception group based in Stafford, Va., for instance, argues that emergency contraception is the same as the abortion of a fetus because a fertilized egg might be destroyed.

The American Medical Association has "strongly encouraged" approval of the second Barr application, saying that the usual dose Plan B does not terminate a pregnancy, but prevents one.

During Senate hearings in March, Crawford, a veterinarian by training, was asked whether he sees emergency contraception as a means of preventing pregnancy.

"I may need to consult with the experts in the FDA about exactly what the physiology of it is," he said, "but it is... the label will say prevention." He said that a decision on the application was taking longer than scheduled "because it's a very complex approval process." FDA spokeswoman Susan Cruzan told Women's eNews that the application is pending and that the FDA is "working toward labelability." Completing the final label is a critical aspect of every over-the-counter approval.

Barr Laboratories said that there "has been little activity" on the label since January. If made available in drugstores, Plan B will be the first hormonal birth control pill available to women in the United States without a prescription.

With or without a prescription, it is expensive. A two-pill packet sells for the same as a month's worth of birth control pills, between $30 and $40.