WASHINGTON, DC – Senators Hillary Rodham Clinton and Patty Murray, joined by nearly 10,000 supporters, today called on the Food and Drug Administration to make a yes or no decision on the pending application for over-the-counter status of Plan B based on science, not ideology. Senators Clinton and Murray submitted their petition letter to the FDA today in response to the agency’s request for public comment on the Plan B application.
“It is time for the FDA to stop dragging its feet and make a decision on Plan B, yes or no. We are proud to join with nearly 10,000 Americans in calling on the FDA to take a real step toward closing its credibility gap by making a prompt decision based on scientific evidence,” said Senators Clinton and Murray.
On August 26, the FDA announced a new public comment period on the application to make Plan B emergency contraception available over the counter. This action amounts to an indefinite delay in consideration of the application and flies in the face of the mounting scientific and medical evidence that emergency contraception is a safe, effective method for reducing the rate of unintended pregnancies. Senators Clinton and Murray launched their petition on their web sites on October 16 to provide another avenue for those who wished to comment on the Plan B application. Today is the deadline for the FDA comment period and the FDA has not announced its next steps in considering the pending Plan B application.
The text of the petition letter Senators Clinton and Murray submitted today to the FDA follows:
Andrew C. von Eschenbach, MD.
Acting Commissioner Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857-0002
Dear Dr. von Eschenbach:
We write in response to your request for comments on the pending application to make Plan B available over the counter.
As an initial matter, we are disturbed that this application has been subjected to scrutiny that far exceeds the normal FDA procedures. It is virtually unprecedented for an over-the-counter application to be subjected to more than two years of inaction, only to be then subjected to an extended public comment period with no timetable for a decision. This entire process, and particularly the decision to initiate rule-making at this late state in the process of considering an application is a troubling precedent for an agency charged with making decisions rooted in scientific and legal grounds.
As you know, the available scientific data indicate that emergency contraception (EC) helps prevent thousands of unintended pregnancies every year, without increasing the rates of unprotected sex. The FDA approved EC for the express purpose of preventing pregnancy, and the Guttmacher Institute estimated that in 2000 alone, use of EC prevented more than 50,000 abortions. Since that time, sales of EC have grown dramatically and researchers estimate that if made available over the counter, emergency contraception could prevent as many as half of the 3 million unintended pregnancies in the U.S. annually.
More than 70 organizations, including the American Medical Association and the American Academy of Pediatrics, have voiced their support for making Plan B available over-the-counter. A May 2004 statement by the American College of Obstetricians and Gynecologists called your agency's failure to approve this application, despite the nearly unanimous recommendation of its own advisory panels "morally repugnant" and "a tragedy for American women." Just recently, the widely respected Assistant Commissioner for Women's Health and Director of the Office of Women’s Health at the FDA, Dr. Susan Wood, resigned in protest, stating that she has "spent the last 15 years working to ensure that science informs good health policy decisions [and] can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled."
In your request for public comment, you cited particular concerns about access to emergency contraception for young girls. This act was a major deviation from the FDA’s normal standards for evaluating the safety and efficacy of reproductive health products, which have treated all women of child-bearing age the same. It appears the FDA is changing the rules midstream. Furthermore, according to press reports, high-ranking FDA scientists including Dr. John Jenkins, director of FDA's Office of New Drugs, wrote internal memos stating that Plan B did not pose any particular risks for younger women and that the agency was subjecting the application to more rigorous examination than applications for other drugs. Dr. Jenkins said Barr's application was "fully consistent with the agency's usual standards for meeting the criteria" for OTC status.
In any case, several products available for sale in our society are already restricted by age. Retailers are prohibited from selling alcohol and tobacco products, including Nicorette, the FDA-approved gum aimed at reducing nicotine addiction, to minors. Many retail chains, such as Wal-Mart, Best Buy and Target, have already policies for verifying the age of purchasers as a means of enforcing these restrictions. Surely pharmacies, if they do not already, could follow suit.
Furthermore, the FDA has had more than a year to develop a strategy for overcoming complications that could arise from selling a product with age restrictions. Instead you have opted for inaction, waiting until the last conceivable moment, seven months past the agency's own deadline, to announce yet another cause for delay.
The fact is that not one reputable medical or scientific organization and few, if any, of the scientists within the FDA's own ranks support the decisions of the agency you head on this matter. The continued delays are damaging the reputation of the entire FDA and putting women's health at risk.
We urge you to expeditiously make a decision on the application for OTC status for Plan B based strictly on scientific evidence.