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On May 7, the FDA issued a "Not Approvable" letter in response to Barr Pharmaceuticals, Inc.'s request for OTC status for its emergency contraceptive (EC), Plan B. This occurred despite overwhelming evidence of the product's safety and potential for reducing the number of abortions in the United States. As voting members of the Reproductive Health Drugs Advisory Committee, we were incensed and deeply disappointed by the decision but not entirely surprised, given the recent track record of the current administration.
Available by prescription since 1999, Plan B consists of two 0.75-mg levonorgestrel pills to be taken 12 hours apart as soon as possible, but within 72 hours, of having unprotected sex. Levonorgestrel, a synthetic progestin with an exemplary safety record, has been used in birth control pills for more than 35 years. Because it contains no estrogen, it's very unlikely the drug would cause thrombosis and it has very few side effects. Moreover, it reduces pregnancy rates from 8% to less than 1%, and to 0.4% when used within 24 hours of unprotected intercourse.
Right now the biggest drawback of all ECs is that they require a prescription. In most cases, that means the woman must schedule an outpatient visit with her physician or make an unplanned trip to the emergency room. Having to contact a provider is inconvenient, expensive, embarrassing, and can prevent or delay a woman from starting the EC, which only increases her risk of an unwanted pregnancy. Despite these obstacles, prescription-based ECs have already reduced the number of induced abortions in the US by an estimated 51,000.1 Given that there are 3 million unwanted pregnancies and nearly 1 million abortions in this country each year, readily accessible and inexpensive ECs could prevent hundreds of thousands of induced abortions each year.
It made perfect sense for Plan B's manufacturer to apply for OTC status. Not only did the product meet all the criteria for such approval, including safety, efficacy, ease of use, the ability to recognize the condition to be treated, and low potential for abuse, but giving the public increased access would reduce the number of unwanted pregnancies. Indeed, the FDA convened a joint meeting of its Nonprescription Drugs and Reproductive Health Drugs Advisory Committees on December 16, 2003 to consider the application. We reviewed an enormous mass of material on Plan B. In two separate votes, the joint committees unanimously agreed 28 to 0 that the data showed the product was safe when used in an OTC setting and wouldn't encourage women to substitute emergency for regular contraception. We then voted overwhelmingly (23 to 4) to approve Plan B for OTC use, a conclusion that was also supported b y the FDA's staff.
In an extraordinarily unusual decision, Dr. Steven Galson, Acting Director of the FDA's Center for Drug Evaluation and Research, overturned the recommendations of the joint committee and his own staff in issuing the "Not Approvable" letter. He based his decision on the fact that the sponsor's application contained no data on subjects under age 14 and very limited data on the use of Plan B by adolescents aged 14 to 16. To his credit, Dr. Galson did ironically state, "Although we did not have sufficient data to approve this application now, I will be working toward the expeditious evaluation of Barr's response to the 'Not Approvable' letter. If Plan B is approved for nonprescription use, it would dramatically increase access to this product and will represent an important incremental step forward in contraceptive availability in the United States...."
What was behind this decision? The FDA never asked our committee to consider whether OTC use of Plan B by girls under age 16 should be restricted. During deliberations, the few opponents of approval voiced concerns about whether OTC availability would reduce condom use and opportunities for physicians to counsel sexually active adolescents and would increase risk of sexually transmitted diseases and adolescent sexual activity. Despite these concerns, they voted with the majority (28 to 0) that the data available from actual trials did not demonstrate these effects. Indeed, the FDA does not restrict access to Tylenol because a woman may delay seeking a physician's care for her brain tumor by self-treating her headache.
While we have no objective evidence that Dr. Galson's decision was politically motivated, his arguments mirrored those of more radical elements of the pro-life community. Moreover, the joint committee members know that unprecedented pressure has and is being brought to bear against FDA approval by a small cadre of conservative congressmen, led by U.S. Representative David Weldon, MD (R-FL). In a press release, he stated, "As a physician, I have witnessed how patients treat themselves at the pharmacy with little knowledge of the potential health risks of their treatment or behaviorparticularly sexual activity. Since adolescents are most vulnerable to STDs, anything that would create an enhanced perception of safety regarding this inherently dangerous behavior is bad public policy. It would leave physicians out of the treatment loop and could exacerbate the already epidemic levels of STDs, including HIV/AIDS and HPV." Weldon then issued a letter to President Bush, signed by 49 like-minded colleagues. Aside from their obvious paternalism, the congressman's assertions are bereft of data, but not of political implications for an administration desperately trying to hold on to its conservative base.
We find it offensive that religious ideology and partisan politics have been introduced into the decision-making process regarding a public health issue. Those who oppose OTC status for Plan B have taken a position that defies logic. Whether someone is pro-life or pro-choice, how can he or she oppose a measure that would reduce the need for abortions? Moreover, anyone who thinks that maintaining the prescription status of Plan B will somehow stem the tide of teenage sex or increase chastity is hopelessly naive. Rates of teenage pregnancy and abortions have fallen steadily over the past decade, in part, because of increased access to contraception.2
Finally, this action is a flagrant example of the intrusion of religious ideology and conservative activismenveloped in a thin veneer of pseudoscienceinto what should be a scientific and empirical examination of the evidence by an objective, secular, and unbiased expert government advisory committee. Dr. Galson's action is just the latest in a disturbing pattern by the Bush administration of altering the membership3 or dismissing the opinions of government committeesand if all else fails, disbanding them altogether when their conclusions run afoul of partisan political or conservative ideological positions.4 Regular readers of Contemporary OB/GYN's editorials know that congressional Democrats have stone-walled tort reform. While the Bush administration is our steadfast ally on professional liability, its recent actions on reproductive health issues create a real dilemma for America's ob/gyns come November.
A prior Contemporary OB/GYN editorial ("Profiles in cowardice," November 2003) has described President Kennedy's book Profiles In Courage and its depiction of great American statesmen who sacrificed their political careers for noble causes. We hope that Acting Director Galson will write his own chapter in that never-ending story by quickly approving the manufacturer's revised submission, and thus, helping to restore our faith in the integrity of the federal advisory committee system, and in our government.
1. Jones RK, Darroch JE, Henshaw SK. Contraceptive use among U.S. women having abortions in 2000-2001. Perspect Sex Reprod Health. 2002;34:294-303.
2. Steinbrook R. Waiting for plan Bthe FDA and nonprescription use of emergency contraception. N Engl J Med. 2004;350:2327-2329.
3. Blackburn E. Bioethics and the political distortion of biomedical science. N Engl J Med. 2004;350:1379-1380.
4. Steinbrook R. Science, politics, and federal advisory committees. N Engl J Med. 2004;350:1454-1460.
Charles J. Lockwood, MD
Charles Lockwood. Editorial: Playing politics with womens health: The FDA and Plan B.
Jul. 1, 2004;49:11-15.