By Susan F. Wood and Kirsten Moore
Recently, new leadership at the U.S. Food and Drug Administration (FDA) took a seemingly small but vitally important step toward restoring scientific integrity at the agency. The FDA notified the manufacturer of Plan B emergency contraception that it could change the age at which consumers can buy the product without a prescription from age 18 to age 17. This is good news for women, and good news for science. This change comes in response to a Federal District court ruling that, for the first time ever, found the FDA guilty of violating the scientific integrity of the drug approval process.
Despite the many highly effective birth control options women and their partners have to choose from, none is 100 percent perfect. And sometimes, mistakes happen -- a condom breaks, a diaphragm slips, a woman forgets to take her pill. Or she has sex when she didn't plan to -- or is raped. Each year, there are about 3 million unintended pregnancies in the United States, including approximately 1 million teen pregnancies. Being able to use backup birth control in time to prevent pregnancy can help a woman take control of a frustrating or even scary situation.
Plan B is a safe, effective back-up birth control method that can prevent pregnancy after unprotected intercourse, or IF contraception fails. Plan B does not cause an abortion, and it will not work if a woman is already pregnant. Plan B is more effective the sooner it is taken (within hours) which is why so many public health officials -- pediatricians, pharmacists, nurses and scientists at the FDA -- have long advocated that it be made available without a prescription. It is one more tool in our toolbox to prevent an unintended pregnancy.
Unfortunately, the medical and scientific consensus was ignored by political leadership at the FDA, who dragged their feet for more than three years, taking action only when it was clear they had run out OF options. At least that was the conclusion reached by Judge Korman in Tummino et al v. von Eschenbach, who ruled that the FDA's justification for the denial of over-the-counter access to Plan B for women "runs counter to the evidence" and "is so implausible that it could not be ascribed to a difference in view or the product of agency expertise."
In his decision, the judge reviewed the timeline of action -- or inaction -- on Plan B, noting that it was only when a new commissioner was being vetted by Congress that there was any movement on the application. During this time, the FDA kept moving the goal post -- initially denying the over-the-counter application flat out; then delaying on an application to make it available only to those 16 and older; then delaying to make it available to those 17 and older, and finally deciding that it would be available to those 18 and older. The FDA's rationale was not based on the interests of women or of public health or medical evidence. Instead, it was based on a perception that a cutoff of 18 would be easier for pharmacies to implement.
The arbitrary nature of that action back in 2006 is what fueled the judge's two pronged decision. He stated that the FDA's age line was ad-hoc, and required that the agency make Plan B available to women age 17, followed by a process to re-review the age restriction. While last week's announcement by FDA does not accomplish that goal outright -- the company must first submit a revised application for approval -- it backs up the administration's stated commitment to restore scientific integrity in policymaking.
Even if the FDA were to approve availability of Plan B tomorrow, however, there is more work to be done. The judge also directed the FDA to revisit the rationale for any age restriction, citing memos written by the agency’s own scientists, a Government Accountability Office review of the FDA's handling of Plan B, and testimony from current and former FDA officials.
We encourage a prompt and speedy review of the evidence, as we strongly believe that over-the-counter access Plan B should be available to anyone who runs the risk of unintended pregnancy. The court has given the FDA a second chance to get their decision right, showing confidence that new leadership will allow the FDA to get back to work based on science and the public's health, without interference. We share that confidence.
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Wood is a research professor at George Washington University’s School Of Public Health and Health Services and former assistant commissioner for Women's Health at the FDA. Moore is president and CEO of the Reproductive Health Technologies Project.
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Copyright (C) 2009 by the American Forum. 5/09
Despite the many highly effective birth control options women and their partners have to choose from, none is 100 percent perfect. And sometimes, mistakes happen -- a condom breaks, a diaphragm slips, a woman forgets to take her pill. Or she has sex when she didn't plan to -- or is raped. Each year, there are about 3 million unintended pregnancies in the United States, including approximately 1 million teen pregnancies. Being able to use backup birth control in time to prevent pregnancy can help a woman take control of a frustrating or even scary situation.
Plan B is a safe, effective back-up birth control method that can prevent pregnancy after unprotected intercourse, or IF contraception fails. Plan B does not cause an abortion, and it will not work if a woman is already pregnant. Plan B is more effective the sooner it is taken (within hours) which is why so many public health officials -- pediatricians, pharmacists, nurses and scientists at the FDA -- have long advocated that it be made available without a prescription. It is one more tool in our toolbox to prevent an unintended pregnancy.
Unfortunately, the medical and scientific consensus was ignored by political leadership at the FDA, who dragged their feet for more than three years, taking action only when it was clear they had run out OF options. At least that was the conclusion reached by Judge Korman in Tummino et al v. von Eschenbach, who ruled that the FDA's justification for the denial of over-the-counter access to Plan B for women "runs counter to the evidence" and "is so implausible that it could not be ascribed to a difference in view or the product of agency expertise."
In his decision, the judge reviewed the timeline of action -- or inaction -- on Plan B, noting that it was only when a new commissioner was being vetted by Congress that there was any movement on the application. During this time, the FDA kept moving the goal post -- initially denying the over-the-counter application flat out; then delaying on an application to make it available only to those 16 and older; then delaying to make it available to those 17 and older, and finally deciding that it would be available to those 18 and older. The FDA's rationale was not based on the interests of women or of public health or medical evidence. Instead, it was based on a perception that a cutoff of 18 would be easier for pharmacies to implement.
The arbitrary nature of that action back in 2006 is what fueled the judge's two pronged decision. He stated that the FDA's age line was ad-hoc, and required that the agency make Plan B available to women age 17, followed by a process to re-review the age restriction. While last week's announcement by FDA does not accomplish that goal outright -- the company must first submit a revised application for approval -- it backs up the administration's stated commitment to restore scientific integrity in policymaking.
Even if the FDA were to approve availability of Plan B tomorrow, however, there is more work to be done. The judge also directed the FDA to revisit the rationale for any age restriction, citing memos written by the agency’s own scientists, a Government Accountability Office review of the FDA's handling of Plan B, and testimony from current and former FDA officials.
We encourage a prompt and speedy review of the evidence, as we strongly believe that over-the-counter access Plan B should be available to anyone who runs the risk of unintended pregnancy. The court has given the FDA a second chance to get their decision right, showing confidence that new leadership will allow the FDA to get back to work based on science and the public's health, without interference. We share that confidence.
-----------------------------------------------------------------------------
Wood is a research professor at George Washington University’s School Of Public Health and Health Services and former assistant commissioner for Women's Health at the FDA. Moore is president and CEO of the Reproductive Health Technologies Project.
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Copyright (C) 2009 by the American Forum. 5/09
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