Medical Device Daily Associate

After countless delays that many say were based on politics rather than science, the FDA finally approved the supplemental New Drug Application (sNDA) of Barr Pharmaceuticals (Woodcliff, New Jersey) for over-the-counter (OTC) marketing of the Plan B (levonorgestrel) emergency contraceptive without a prescription.

Importantly, the approval of the so-called morning-after pill could also potentially open the door to the removal on the playing-politics hold of the nomination of Andrew von Eschenbach, MD, for the FDA commissioner post. He would replace Lester Crawford, MD, who resigned in July 2005, roughly three months after receiving the nomination.

The bid to sell the Plan B product without a prescription lingered at the agency for more than three years, drawing criticism that the FDA was delaying approval because of political pressure brought by opponents who argued it would lead to greater promiscuity and was tantamount to an abortion.

The FDA granted OTC status to Barr's wholly owned subsidiary, Duramed Pharmaceuticals , to sell the product to consumers 18 years of age and older, while maintaining the prescription status for women 17 and younger.

The company said its Plan B OTC product and the prescription product will be marketed as a single package, which will allow for a prescription label to be adhered to the package when dispensed to women age 17 and younger. Additionally, because Plan B will remain a prescription product for women 17 and younger, it will be sold in retail pharmacy outlets from behind the counter.

Duramed said it plans to introduce the dual status Rx/OTC version of the product before year-end.

As part of the OTC approval, the company said it has reached an agreement with the FDA on its CARE (Convenient Access, Responsible Education) program that supports efforts to ensure that Plan B is used “responsibly and appropriately.” The CARE program is designed to limit the availability of Plan B only to pharmacies and clinics with professional healthcare supervision, to educate healthcare professionals and consumers within the target age groups regarding the availability and responsible use of Plan B, and to monitor the effectiveness of the program.

In addition, the company said it intends to work closely with retail pharmacies and drug wholesalers to ensure that they understand and follow the FDA's prescription age requirement for the dispensing of the product.

“While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product,” said Bruce Downey, Barr's chairman and CEO. “Although Plan B will continue to be available to all women of child-bearing age, we believe making Plan B available without a prescription to those 18 and older will ensure that millions of women have more timely access to an emergency oral contraceptive following unprotected sexual intercourse or a contraceptive failure.” He added that the company will continue its efforts with the FDA “to reduce the age restriction on the OTC use of Plan B.”

Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89% after a single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment increases. Plan B is more effective when taken in the first 24 hours after intercourse. The decline in efficacy from a delay in treatment is why a broad range of health professionals believe that barriers to more timely access to Plan B should be removed, including making the product broadly available without prescription.

There are nearly 3 million unintended pregnancies each year in the U.S, according to the company.

Plan B is made from a synthetic hormone found in regular oral contraceptives. Like the regular contraceptive pill taken by millions of women every year, it generally acts by preventing ovulation or fertilization, according to the FDA. Plan B may in rare circumstances prevent a fertilized egg from becoming implanted — something abortion opponents decry. But regular oral contraceptives would prevent implantation in the same way.

In response to the FDA's action, two Democratic senators dropped long-standing objections to President George Bush's nomination of von Eschenbach to head the FDA, though now conservative groups are calling for a new nominee, citing what they perceive as his acceptance of a product that they say promotes abortion.

Sens. Hillary Clinton (D-New York) and Patty Murray (D-Washington) have said for months they would block a full Senate vote on the nomination of von Eschenbach, who is currently the acting FDA commissioner, until the agency decided whether to allow wider access to the controversial contraceptive.

The two senators were so concerned about the delays surrounding Plan B that they placed a legislative hold on Crawford's nomination last year. The senators lifted that hold after Health and Human Services Secretary Michael Leavitt promised that the FDA would act on the Plan B application by Sept. 1 of last year.

After Crawford was confirmed, the agency announced a further delay in the application, something Murray said in an interview amounted to “the worst double-cross I've ever seen in my time in the Senate.” Leavitt responded that the delay amounted to “an action.”

While pleased with the approval, the senators said they believe the agency should make the pill more widely available. “While we urge the FDA to revisit placing age restrictions on the sale of Plan B, it is real progress that millions of American women will now have increased access to emergency contraception,” the senators said in a statement.

A growing number of conservative groups, angered by von Eschenbach's Plan B decision, say they now want someone else to lead the FDA, which has been without a permanent commissioner for most of the Bush administration.

“The FDA's irresponsible action today takes those rights out of a parent's hands and gives them to ill-intentioned perpetrators,” said Concerned Women for Amer-ica 's Wendy Wright, whose group has joined others calling for a new nominee.

Despite the disapproval of his conservative base, Bush earlier this week said he supported von Eschenbach, who approved granting the wider access to the pill.

In a press briefing on Monday, Bush was asked whether he supported von Eschenbach's intention to approve OTC sales of Plan B – a rare moment when a president addressed an application pending before the agency. Bush said that minors should need a prescription to obtain Plan B. “And I support Andy's decision,” he said.