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Center for Reproductive Rights Takes FDA to Court (Again) Over Emergency Contraception Access

Recent failings by the U.S. Food and Drug Administration (FDA) to comply with a court order regarding widespread access to emergency contraception (EC) prompted the Center for Reproductive Rights (CRR) to file a motion for contempt. The motion, filed on November 16, 2010, cited the March 2009 ruling in which the FDA’s decision to limit over-the-counter access to the emergency contraceptive Plan B was proclaimed to be based on politics rather than science. The previous court order to reconsider the refusal to make EC available to all women has been essentially ignored by the Obama administration and the FDA itself for the last year and a half.[1]
 
This is despite the fact that President Obama previously declared that politics would no longer play a part in matters of scientific policy, confirming new FDA commissioner, Margaret Hamburg, who had stated that it was her goal to make the FDA’s decisions based more soundly on scientific evidence. Said Obama, “We make scientific decisions based on facts, not ideology.”[2]
 
Nancy Northrup, the president of the CRR, deplored the amount of time that had passed with no decisive action from both the FDA and the Obama administration on the issue of access to EC for women of all ages. “The FDA has had ample time, countless opportunities, and overwhelming scientific evidence put before it to make a decision on Plan B,” said Northrup upon filing the motion for contempt. “The President promised that his administration would reverse the Bush policy of politics trumping science. But when it comes to emergency contraception, it’s a new administration playing the same old games.”[3]
 
This is not the first time the FDA has refused to comply with recommendations to make EC available to consumers. In 2004, the FDA rejected Barr Laboratories’ applicationto make Plan B emergency contraception available over the counter (OTC) without a prescription. The FDA’s rejection of Barr’s application after it received overwhelming support from both the health professionals and the FDA’s advisory committees was unprecedented. In December 2003, two FDA advisory committees recommended 23 to 4 that Plan B be made available OTC with no restrictions. A decision regarding the switch to OTC status from that of prescription only had been expected by February 20, 2004. However, the FDA requested and received a 90-day extension to continue its review, and subsequently issued the “Not Approvable” letter in May 2004.
 
Many officials employed by the FDA showed their outrage of the administration’s surrender to political sway over scientific fact by resigning. In 2005, Dr. Frank Davidoff, editor emeritus of the Annals of Internal Medicine,submitted a letter of resignation to the FDA, declaring his protest of the handling of the decision on whether to grant OTC emergency contraception. “I can no longer associate myself with an organization that is capable of making such an important decision so fragrantly on the basis of political influence, rather than the scientific and clinical evidence,” wrote Davidoff. “I’m truly sorry it has come to this.”[4]
 
In 2006, Judge Viktor Pohorelsky, a federal judge for the second circuit of the U.S. Court of Appeals granted CRR’s motion for a subpoena of White House records regarding the decisions about EC made by the FDA. The subpoena gave CRR access to over three years of White House documents that included important correspondence with FDA officials.[5]
 
This measure paved the way for the FDA’s approval of over-the-counter access to Plan B for women over the age of 18 without a prescription in August of 2006. While this was momentous for advocates of access to EC, barriers for women under the age of 18 still were a prime concern. Young women who were under the age of 18 were required to obtain a prescription from their health care provider to receive Plan B, making it more difficult for them to access the drug.
 
In April 2007 the approval of access to EC faced another hurdle when several right-wing organizations, including the Family Research Council, Concerned Women for America, the Association of American Physicians, and Safe Drugs for Women filed a lawsuit that alleged that the FDA did not have the authority to approve the same drug and labeling for simultaneous nonprescription and prescription-only distribution. The court ruled the suit had no legal standing and threw it out, while the CRR moved forward with its own legal battle, filing another lawsuit against the FDA to approve the sale of over-the-counter EC for women of all ages. A small victory was achieved in July 2009 when the FDA lowered the age for needing a prescription from 18 to 17.[6]
 
Now CRR, in concordance with the Reproductive Health Technologies Project (RHTP), are holding the FDA accountable to their promise to reconsider making EC available to women of all ages through filing this motion for contempt. Both organizations are extremely frustrated with the lack of progress on an issue that is seemingly straightforward in its benefits. “The FDA is hiding behind procedural delays. It can—and should—respect its own scientists’ recommendations and lift the age restrictions on over-the-counter emergency contraception,” said Kirsten Moore, President and CEO of RHTP. “A woman is best served by simple, over-the-counter access to emergency contraception so she can prevent unintended pregnancy. Why would we hide this important back up birth control method behind a pharmacy counter?”[7]
 
Advocates for lifting the age ban on access to EC have joined with CRR and RHTP in their support of the motion for contempt. “The FDA has too long delayed unrestricted access to emergency contraception, which is essential to the health of women of all ages. The FDA should honor their own scientists’ recommendations and lift the age-restriction immediately,” comments Jen Heitel Yakush, director of public policy at the Sexuality Information and Education Council of the United States. “We commend the Center for Reproductive Rights and Reproductive Health Technologies Project for their actions and hope this will create the progress needed to make over-the-counter emergency contraception available to all who need it.”
 
 
 


[1] The Center for Reproductive Rights, “The Center Takes the FDA Back to Court,” Press Release published November 2010, accessed 23 November 2010,<http://reproductiverights.org/en/feature/the-center-takes-the-fda-back-to-court>.
[2] Ibid.
[3] The Center for Reproductive Rights, “CRR Takes FDA Back to Court Over Morning-After Pill: Says Obama FDA Is Still Ignoring Science and Playing Games with Women’s Health Like Bush FDA,” Press Release published 16 November 2010, accessed 23 November 2010, <http://reproductiverights.org/en/press-room/crr-takes-fda-back-to-court-over-morning-after-pill>.
[4] Rinker Buck, “Plan B Casualties,” Hartford Courant, 2 October 2005, accessed 7 December 2010, <http://articles.courant.com/2005-10-02/news/0509300527_
[5] “Group Can Seek White House, FDA Records about Plan B Pill,” Washington Post, 9 November 2006, accessed 9 November 2006, <http://www.washingtonpost.com/wp-dyn/content/article/2006/11/08/AR2006110801877_pf.html>.
[6] Jennifer Corbett Dooren, “FDA Approves New Plan B Labeling,” Wall Street Journal, 14 July 2009, accessed 16 July 2009, <http://online.wsj.com/article/SB10001424052970203739404574288451581882622.html?mod=googlenews_wsj>.
[7] Reproductive Health Technologies Project, “Women’s Health Advocates Tell the FDA to End Unnecessary Age Restrictions on Emergency Contraception,” Press Release published 23 March 2010, accessed 23 November 2010, <http://www.rhtp.org/documents/CourtCaseAnniversaryStatementFINAL.doc>.

 

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