Several steps were taken during July in the on-going effort to make emergency contraception (EC) available over-the-counter to women in the United States. EC is a high dose of regular birth control pills that can reduce a woman’s chance of becoming pregnant by 75 to 89 percent if taken within 72 hours of unprotected intercourse.

On July 22, Barr Laboratories responded to the "not approvable" letter issued in May by the U.S. Food and Drug Administration (FDA). In releasing a "not approvable" letter, FDA’s Center for Drug Evaluation and Research acting director Dr. Steve Galson vetoed the expert advice and recommendations of the FDA’s own Nonprescription Drugs Advisory Committee, the Reproductive Health Drugs Advisory Committee, and medical-review staff all of whom overwhelming supported putting Plan B on the market as an over-the-counter (OTC) drug. The two FDA committees voted unanimously that there was substantial evidence that Plan B would be safe for use as an over-the-counter drug and voted 23-4 to change the status of Plan B to nonprescription.¹

In the "not approvable" letter, Galson stated that more specific data was needed from Barr on females under the age of 16. Yet, according to Dr. Robert Steinbrook who wrote an article for the New England Journal of Medicine about the FDA’s decision not to grant OTC status to Plan B, "children may purchase acetaminophen, aspirin, and nonsteroidal anti-inflammatory medications without a prescription and without an age check. The FDA has never required specific data on the safe and correct use of these or other medications in children and adolescents, although their improper use is harmful and potentially lethal."²

Barr’s July 22 response suggests a dual status for Plan B, meaning that the product would be available OTC to women aged 16 and older but only available with a prescription for those aged 15 and younger. The FDA now has 180 days to respond to Barr’s proposal, although dialogue could begin as early as October.

Advocates of reproductive health say that while this prescription-based-on-age proposal is unprecedented in the U.S. drug market, it may be the only way to achieve OTC status at this time. "Unfortunately, Barr has to make the best of a bad situation. This is a compromise forced by politics," says Kirsten Moore, president of the Reproductive Health Technologies Project. "Nevertheless, approval of an OTC product for some women will be a tremendous victory."

It is expected that if this plan is accepted, Plan B would be kept behind the counter and customers would have to specifically request it from the pharmacist. An advantage to this arrangement is that non-pharmacists order and monitor the purchasing of OTC drugs on the shelves, while pharmacists are in charge of all products behind the counter. Having a pharmacist oversee the supply of Plan B could ensure ample stock of the product. However, keeping EC behind the counter places a barrier of access for those aged 16 and above.

As Lorraine Tulman, RN, M.S. stated in December 2003 during the FDA meeting of the Center for Drug Evaluation and Research and Nonprescription Drugs Advisory Committee (NDAC) in joint session with the Advisory Committee for Reproductive Health Drugs (ACRHD), "When it comes to consumer access, I would urge it not be a behind-the-counter, but be an on-the-shelf access. . . . in my local pharmacy, there are at any one given moment about 30 people waiting for their prescription, and the least thing I would want is a pharmacist and I to hold a conversation about my sex life in front of my 30 neighbors standing behind me very impatient waiting for their prescriptions."³

Pharmacy access programs, currently existing in six states- Alaska, California, Hawaii, Maine, New Mexico, and Washington- allow pharmacists to write a prescription for EC. These programs are not expected to be negatively affected or altered in any way if the dual status proposal is approved by the FDA.⁴

Advocates are concerned, however, that some pharmacists might not be cooperative. There are recorded cases across the country of some pharmacists denying contraceptives to women of all ages.⁵

If the dual status approach is approved by the FDA, Barr Laboratories can then begin discussions with the agency as to the best method to make Plan B OTC for all women in the United States, regardless of age.

While Barr Laboratories, Inc. engages with the FDA, they are also receiving assistance from Capitol Hill. The General Accounting Office (GAO) has agreed to perform a formal investigation into the FDA’s decision to reject Plan B from becoming over-the-counter. A bi-partisan group of Representatives and Senators made the request to the agency due to the unusual nature of the FDA issuing a "not approvable" letter after overwhelming expert opinion that Plan B would be safe and effective as an OTC drug for women of all ages.

In addition to the GAO investigation, Senator Hillary Clinton and several of her colleagues called for oversight hearings to better determine the basis of the FDA’s decision. As a result, eight of the ten Democratic Senators on the Health, Education, Labor, and Pensions Committee are expected to meet with FDA acting commissioner Dr. Lester Crawford and Center for Drug Evaluation and Research acting director Dr. Steve Galson in September when the Senate is once again in session.

Read more about efforts to make EC OTC.

Read past SIECUS policy updates on EC, please see May 2004.

References

1. United States Food and Drug Administration Center for Drug Evaluation and Research, Nonprescription Drugs Advisory Committee (NDAC) in Joint Session with the Advisory Committee for Reproductive Health Drugs (ACRHD), Meeting, Tuesday, December 16, 2003. Available online.
2. R. Steinbrook, M.D., "Waiting for Plan B – The FDA and Nonprescription Use of Emergency Contraception," New England Journal of Medicine, 350;23, p.p. 2327-2329.
3. United States Food and Drug Administration Center for Drug Evaluation and Research, Nonprescription Drugs Advisory Committee (NDAC) in Joint Session with the Advisory Committee for Reproductive Health Drugs (ACRHD), Meeting, Tuesday, December 16, 2003. Available online.
4. "Emergency Contraception (EC) Pharmacy Access Programs," Pharmacy Access Partnership and Reproductive Health Technologies Project, July 2004. Available online.
5. See C. Bollinger, "Access Denied: Find out why growing numbers of doctors and pharmacists across the US are refusing to prescribe or dispense birth control pills," Prevention, July 2, 2004.