via Reproductive Health Technologies Project, which just sent around the following disappointing news:
“Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step
The U.S. Food and Drug Administration (FDA) has been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse.
Plan B One-Step is a single-dose pill (1.5 mg levonorgestrel tablet) which is effective in decreasing the chance of pregnancy if taken within 3 days after unprotected sexual intercourse. The product contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to birth control pills.
Plan B One-Step was originally approved in July 2009 for use without a prescription for females age 17 and older and as a prescription-only option for females younger than age 17. In February 2011, Teva Women’s Health Inc. submitted a supplemental application seeking to remove the prescription-only status for females younger than age 17 and to make Plan B One-Step nonprescription for all females of child-bearing potential.
The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step. Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.
It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence. The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process. Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs. CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.
I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.”
Kirsten Moore, President and CEO of RHTP, told Ms. Magazine: “We are outraged that this Administration has let politics trump science. There is no rationale for this move. This is unprecedented as evidenced by the Commissioner’s own letter. Unbelievable.” In the same story, Dr. Susan Wood, who resigned from the FDA over the Bush Administration’s decision to Plan B and is currently the former FDA Assistant Commissioner for Women’s Health and associate professor of Health Policy and Director of the Jacobs Institute at the GW School of Public Health and Health Services, issued the following statement: “This decision is stunning. I had come to believe that the FDA would be allowed to make decisions based on science and the public’s health. Sadly, once again, FDA has been over-ruled and not allowed to do its job. I cannot understand why Secretary Sebelius would reach in and overturn the FDA’s decision to allow timely access for all those who need safe and effective emergency contraception.”
In her letter to FDA Commissioner, Secretary Sibelius said that there were “significant cognitive differences” between older adolescents and younger ones So, if Teva’s application were approved, then the drug would be available without prescription or other point of sale restrictions for even the youngest girls of reproductive age (the average age of menarche in the U.S. is 11.1 years). Never mind that only 1% of all 11 year old’s have been sexually active (and for those, “sexually active” usually means rape or incest).
According to what I’ve read and heard from others in the EC world, this is an unprecedented move by an HHS secretary — i.e. none of her predecessors has ever overruled the FDA on a drug application. (during the George W. Bush administration, the problem was the FDA Commissioner). Is Secretary Sibelius acting on her own, or is she fronting for someone else? We’ll see.
Update: If you want to take action on this issue, please sign the petitions at
In addition, here is a statement from Catholics for Choice:
For Immediate Release
December 7, 2011
Media Contact: Adrianne Burke
+1 202 986 6093
Obama Administration Rejects Scientific Evidence and FDA Advice in Maintaining Restrictions on Emergency Contraception
Continues Barriers for Women Seeking to Prevent Unplanned Pregnancy
In a stunning setback for women’s access to healthcare services, President Obama’s Department of Health and Human Services (HHS) has ignored the advice of the Food and Drug Administration (FDA) to ease the restrictions on the sales of Plan B, a method of emergency, or after-sex, contraception. In a rare sign of public dissent within the administration, the FDA commissioner, Margaret Hamburg MD, wrote, “I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.” The HHS decision to override this recommendation means that the proposal to remove the pills from over-the-counter status, and permit pharmacies to place them on shelves like other safe and effective oral medications, cannot now take place.
The president of Catholics for Choice, Jon O’Brien, said, “We know that conservative pharmacists around the country have treated women condescendingly, expressed contempt and even denied them access to a safe and legal contraceptive for no medical reason. Now, the HHS has overruled the scientifically and medically sound advice from the FDA that it was perfectly OK to move these pills to OTC status for all women. This is a deeply disappointing decision from an administration that promised us it would follow science and sound medical information in making policy decisions. Increasingly, on issues that women care deeply about, the Obama administration seems intent on taking us back to the future.”
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