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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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Plan B OTC ApplicationOn August 24, 2006, the FDA decided to make Plan B EC available without a prescription for consumers 18 and older. Following this decision, all women, including teens and women without proof of age, will still be able to obtain EC directly from specially trained pharmacists (in the states that allow pharmacy access to EC). Click here for more information on the FDA decision. On August 1, 2006, Acting FDA Commissioner Andrew von Eschenbach, who was nominated by President Bush in March 2006 to permanently head the agency, discussed the Plan B application during his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions. Shortly after the nomination was announced in March, Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) announced that they would place a hold on his confirmation vote in the Senate because of the delay on the Plan B decision. Following the Plan B decision, Clinton and Murray lifted the hold. Dr. von Eschenbach’s confirmation is still pending in the Senate. In the case brought against FDA in 2001 and argued by the Center for Reproductive Rights, CRR attorneys in April 2006 deposed FDA Deputy Commissioner Dr. Janet Woodcock and the Director of the FDA’s Center for Drug Evaluation and Research, Dr. Steven Galson, who stated that Crawford did not consult them in his decision to delay the Plan B decision. Galson testified that Crawford "told me that he was concerned about where we were heading because he knew that I was heading towards” recommending over-the-counter status for Plan B for use among girls 17 and up, “and he told me that he was going to make the decision on what to do with the application.” Attorneys in the CRR case also reported that Center for Medicaid and Medicare Services Administrator Mark McClellan, while head of FDA, discussed the Plan B application with a White House official while the Barr application for nonprescription status was pending. A bipartisan group introduced a bill (HR 4229) on November 4, 2005, that, if passed, would make Plan B (the dedicated product for EC) available nationwide without a prescription, for women 17 years and older. The move comes in response to the FDA’s delay in making a decision whether to grant Plan B over-the-counter (OTC) status. The measure would require the FDA to make a decision within 30 days of the bill’s passage, after which time Plan B would automatically be approved for OTC sales. If Plan B is granted OTC status through this legislation, the FDA would still have the power to override the approval at a later date. For comments from Rep. Joseph Crowley, click here. This move comes only days after the deadline for submission for public comment on the issue to the FDA. November 1, 2005, ended the 60-day period to submit comments regarding the pending application to make EC available OTC. The request for public comment came on the heels of the FDA’s most recent delay to grant EC non-prescription status, despite Barr Pharmaceuticals’ efforts to allay the agency’s concerns about teen use, in addition to a wealth of scientific evidence showing that the regimen is safe and effective for women of all ages. According to a senior FDA official who spoke to the Washington Post, as of the November 1 deadline the agency had already recorded receipt of 2,300 comments and was expecting upwards of 10,000 after the final tallies were in. See comments supporting OTC status for EC submitted by Pharmacy Access Partnership (PDF-508), the Reproductive Health Technologies Project and Senators Hillary Clinton (D-NY) and Patty Murray (D-WA), which included 10,000 signatures from advocates nationwide. The FDA was expected to issue a decision on an application to switch Plan B, the product currently available by prescription, to OTC status on September 1, 2005. On July 22, 2004, Barr Pharmaceuticals submitted a formal response (DOC-28K) to the FDA in support of its application for dual access to Plan B: non-prescription for women 16 years and older and prescription-only for women under 16. Click here for a recent Alan Guttmacher Institute review of the proposed age restriction for Plan B. However, days before the expected decision, on August 26, 2005, the FDA issued a surprise notice that a decision regarding the application would be delayed. Instead, the FDA said it would begin another regulatory process, thereby delaying the decision indefinitely. The FDA plans to hold a new 60-day public comment period – with no explicit timetable for a final decision. Click here to read the statement issued by the FDA (DOC-40K). Barr Pharmaceuticals issued a press release (DOC-32K) in response to the FDA’s announcement. As a direct result of the recent delay on a decision, Susan Wood resigned from her post as assistant FDA commissioner for women’s health and director of the Office of Women’s Health. Click here to read Ms. Wood’s correspondence sent to colleagues and women’s health advocates (PDF-28K). On September 6, the Government Accountability Office (GAO) said that in October, it will release findings from its investigation into why FDA last year rejected an application to switch the emergency contraceptive Plan B from prescription to OTC status. Then, on September 23, 2005, Lester Crawford resigned from his position as Commissioner of the Food and Drug Administration (FDA). Click here to read the statement issued by Lester Crawford (PDF-28K). On June 15, 2005, the Senate Health, Education, Labor & Pensions Committee approved the nomination of acting FDA Commissioner Lester Crawford to lead the agency. Following the vote, Senators Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) moved to block a full Senate vote on Crawford’s nomination due to the delay in issuing a decision on the Plan B application. Later, Senator Tom Coburn (R-Okla.) noted that he would place a hold on Crawford’s nomination until the FDA required that condom labels clarify the effectiveness in preventing pregnancy and sexually transmitted infections. Senators Clinton and Murray lifted their hold in mid-July after Secretary of Health and Human Services Michael Leavitt indicated that a decision on Plan B's OTC application would be made. Crawford was confirmed soon after. A decision on dual access was expected in January 2005, however the FDA informed Barr that it was unable to complete its review of the application. View response (PDF-20K) from Pharmacy Access Partnership. Barr had received a Not-Approvable letter on May 6, 2004 for its application for OTC access for women of all ages. For more information about the FDA’s decision in May, view the letter from the FDA (PDF-171K), Barr Laboratories press release (DOC-29K), an AP news story (DOC-21K), and Pharmacy Access Partnership's press release (DOC-90K). Releases were also distributed by the Republican Majority for Choice and the WISH List Women In the Senate and House (PDF-436K). The application to change Plan B to OTC status was first submitted in April 2003 and the FDA officially filed the application on June 20, 2003. On December 16, 2003 a joint meeting of the FDA Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs voted 23-4 to recommend that Plan B be available OTC. Click here (PDF-440K) for the meeting agenda. For an account of the meeting, view reports prepared by the FDA Advisory Committee, Pharmacy Access Partnership (PDF-48K), Physicians for Reproductive Choice (PDF-292K), and American Pharmacists Association (DOC-32K). Barr Laboratories, maker of Plan B, and experts with relevant experience testified and the general public also submitted written and oral comments. The committees’ recommendation is non-binding to the FDA staff. View Archive of Hearing Via Webcast. The FDA was expected to announce its decision on the OTC request on February 20, 2004, but on February 13, 2004 announced it would extend its deadline until May 21, 2004 to permit review of additional data on adolescent use that was submitted by Barr Pharmaceuticals, Inc and Women's Capital Corporation in support of the application. Because of EC’s proven safety, and its public health importance, many organizations have endorsed OTC availability of emergency contraceptives, including the American College of Obstetricians and Gynecologists (PDF-448K), the American Medical Association, and the American Public Health Association. Providers are assessing the impact of EC going OTC. Click to read observations from the American Medical Association and the New England Journal of Medicine. 49 House Republicans, led by David Weldon, R-Fla., have written President Bush to urge that the FDA reject its advisory committee's recommendation to make Plan B available OTC. However, the American College of Obstetricians and Gynecologists as well as several Congressional Democrats responded with letters of support for the switch. The events and debate have raised considerable media coverage. How does improving access at the state level fit in with national efforts to deregulate EC? ?State level changes that allow pharmacists to initiate emergency contraception are highly synergistic with national efforts to gain OTC status.? says Sharon Camp, PhD, founder of WCC, the company that initially made Plan B and applied for OTC status. ?Only the FDA can switch a drug status from prescription to OTC, but states have considerable authority. If enough states grant direct pharmacy access to EC, the OTC switch becomes inevitable. The effort to take Plan B OTC should also help support state-level initiatives by making deregulation an important national issue.? Sharon Camp directed the development of the FDA application — an effort that spans 59 volumes and 15,000 pages. The application includes two key studies – the label comprehension study and the actual use study. The actual use study appears in the July 2003 issue of Obstetrics & Gynecology. The packaging for Plan B is highly regarded for its straight forward and easy to understand information. Since its introduction in 1999, Plan B has become the standard product initiated by pharmacists in states that allow direct pharmacy access. For more information on state-level pharmacy access, visit www.pharmacyaccess.org/ECOTCStatus.htm or read this recent Women’s enews story. Plan B is the only progestin-only emergency contraceptive approved by the FDA. Progestin-only EC produces significantly less nausea than other emergency contraceptives containing both progestin and estrogen. In California, study data shows that over 95% of the EC provided by pharmacists is Plan B. In 2001, a separate nonprofit group, the Center for Reproductive Rights, also petitioned the FDA to change emergency contraception from prescription to over the counter. This “citizens’ petition” generated considerable media interest and support across the country. Interestingly, in 1997, before a dedicated EC product was ever brought to market, the FDA noted in the federal register (DOC-82K) that EC was safe and effective and called on drug manufacturers to apply to make it available. 2001 PETITIONERSAdvocates for Youth OPTIONS FOR GETTING INVOLVED IN EC OTC INITIATIVEProfessional Education
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