Barr to acquire Plan B: EC access to expand?
Emergency contraception (EC), once considered "the nation’s best-kept secret," may be a secret no longer when a major pharmaceutical company takes over a popular dedicated EC product.
Pomona, NY-based Barr Laboratories Inc. has announced its intentions to acquire Plan B, the levonorgestrel-only pill manufactured by Washington, DC-based Women’s Capital Corp. At press time, the acquisition was set to close. Annual sales of Plan B reached about $10 million in 2002; Barr reported $903 million in sales in its most recent fiscal year.1 Plan B was listed as the leading EC pill in the 2003 CTU Contraception Survey; about 58% of respondents said their facility provided the drug.
"As a leading pharmaceutical company with sizable resources, Barr has the ability to greatly expand outreach to the medical community and to provide much-needed education and awareness to consumers," states Ellen Chesler, chairwoman of Women’s Capital Corp. "In addition, Barr will continue to pursue over-the-counter [OTC] status for Plan B and is committing resources to support the OTC switch."
Women’s Capital Corp. filed with the Food and Drug Administration (FDA) in April 2003 to switch the status of Plan B from prescription-only to OTC. The review of the OTC submission is on schedule, and no major problems have arisen to date, according to the company. An FDA advisory hearing of the reproductive health and nonprescription drugs panels is scheduled for mid-December 2003.
Women Capital Corp.’s 59-volume, 15,000-page application contains clinical study data on nearly 11,000 women who have taken the pills used in Plan B after sex to prevent pregnancy. Included in the application were results of the label comprehension study2 and the just-published OTC actual use study, designed to mimic OTC distribution.3
To conduct the actual use study, women at U.S. family planning clinics and pharmacies were enrolled; the facilities did not provide unsolicited counseling about or evaluations for EC pills. Women who requested EC were asked to examine a package that was modified for OTC use and were provided with the study drug (levonorgestrel, two 0.75-mg tablets). Women were contacted one and four weeks later and asked about use of the product, side effects, and pregnancy. Most women used EC pills appropriately without provider evaluation and counseling, study findings indicate.3
Timely access is important for EC, say access proponents. It must be taken within a few days of a contraceptive accident to be effective. If a condom breaks on a Friday night, many women cannot get a provider’s prescription and get it filled in the prescribed 72 hours. OTC status will give women access to the pills quickly, when they are most effective, proponents advocate.
The acquisition of Plan B by a major pharmaceutical company bodes well for EC access, observes James Trussell, PhD, professor of economics and public affairs, faculty associate of the Office of Population Research and associate dean of the Woodrow Wilson School of Public and International Affairs at Princeton (NJ) University. The resources afforded by Barr Labs, such as a larger sales and marketing staff, will allow the drug to be more widely presented to prescribers and pharmacists. If Plan B does gain FDA approval to go OTC, Barr is better positioned to increase awareness of the drug, with such tools as direct-to-consumer advertising, he explains.
Barr sells 15 generic oral contraceptives (OCs) and is launching its first branded birth-control pill, Seasonale, an extended OC regimen product. The addition of Plan B complements the company’s existing product line, says Bruce Downey, Barr’s chairman and CEO.
"As part of our commitment to women’s health care, which includes the expansion of our franchise of oral contraceptive products, we recognize that some women may need a product such as Plan B in the event of an expected contraceptive failure or in the event that no method of contraception was used," states Downey. "By acquiring this product and certain assets from [Women’s Capital Corp.], we offer women an important emergency contraceptive option."
1. Krauskopf L. Barr Labs adding a morning-after pill.’ Bergen Record; Oct. 3, 2003. Accessed at: www.northjersey.com.
2. Raymond EG, Dalebout SM, Camp SI. Comprehension of a prototype over-the-counter label for an emergency contraceptive pill product. Obstet Gynecol 2002; 100:342-349.
3. Raymond EG, Chen PL, Dalebout SM. Actual-use’ study of emergency contraceptive pills provided in a simulated over-the-counter manner. Obstet Gynecol 2003; 102:17-23.
Track EC issues with new web site
Where can you get the latest information on access to emergency contraception (EC)? Visit www.GO2EC.org, a new web site for pharmacists, EC leaders, public health professionals, and community health advocates.
The web site is designed to highlight what states are doing to improve access, increase understanding around the options to improve access in pharmacies, help advocates connect with a broader community of professionals, and share best practices. It is operated by the Pharmacy Access Partnership, part of the Oakland, CA-based Public Health Institute, a public health nonprofit agency.
The web site offers information on all 50 states, with an in-depth look at states providing direct access to EC in pharmacies. Additional sections include models for EC pharmacies, collaborative practice agreements, legislation, resources, personal stories, and the latest on the switch from prescription-only to over the counter.