U.S. District Court Dismisses Lawsuit against FDA over Nonprescription Sales of Plan B

On March 4, 2008, the U.S. District Court for the District of Columbia dismissed a lawsuit that sought to overturn a decision by the Food and Drug Administration (FDA) which allowed nonprescription sales of the emergency contraceptive Plan B to women older than the age of 18.  In its ruling, the court said that the plaintiffs failed “to identify a single individual who has been harmed by Plan B’s [over-the-counter] availability.”1

Plan B, a brand of emergency contraceptive pills, is a high dose of regular birth control pills that can be a safe and effective method of preventing unintended pregnancies if taken up to 120 hours after unprotected intercourse.  Until August 2006, Plan B was only available by prescription.

Due to a protracted and highly political process Barr Laboratories’ application to make Plan B available without a prescription had been pending before the FDA for more than three years. In 2001, the FDA’s own expert staff and advisory panels overwhelmingly voted to make Plan B available over the counter.  While political maneuvering had kept the decision at bay for several years, in August 2006 the FDA approved Plan B as an over-the-counter contraceptive for women 18 and older.  Plan B is available to women under the age of 18; however, younger women must have a prescription from their health care provider in order to obtain the drug.2  Under the FDA guidelines, the age restriction is monitored closely by pharmacists as Plan B is stored behind pharmacy counters and identification is required to verify each consumer’s age.3

The lawsuit was filed in April 2007 by the Family Research Council, along with Concerned Women for America and two front organizations for the right-wing, Association of American Physicians and Surgeons and Safe Drugs for Women.  The lawsuit alleged that the FDA did not have the authority to approve the same drug and labeling for simultaneous nonprescription and prescription-only distribution.  The lawsuit claimed that the FDA could not treat the drug differently based on the age of the buyer because the “FDA lacks the authority to enforce Plan B’s age limitations.”

The suit also alleged that the decision to approve Barr Laboratories’ application was made under “improper political pressure” from Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY).  After years of inaction by the FDA, Senators Clinton and Murray had placed a hold on a vote on the nomination of the FDA's acting commissioner, Dr. Andrew C. von Eschenbach, saying that they would only allow a vote to go forward if a decision—yes or no—was issued on the Plan B application. The senators dropped the hold after the application was approved for women over the age of eighteen.

The court ruled that the groups filing the lawsuit did not have standing to sue.  The court noted that the “plaintiffs have failed to exhaust their administrative remedies and have therefore failed to state a claim upon which relief can be granted.”4 FDA Spokesperson Rita Chapelle said the agency is pleased with the dismissal of the suit.  A spokesperson for Barr Laboratories said the lawsuit was “meritless” and that Barr was pleased with the dismissal.5

The Center for Reproductive Rights has filed a separate lawsuit against the FDA that alleges the agency’s decision to prohibit sales of Plan B to women under the age of 18 was based on politics rather than science. The Center for Reproductive Rights filed the suit in U.S. District Court in New York on January 21, 2005, arguing that the FDA did not follow normal drug-approval procedure when it first denied the application. The lawsuit also argues that in failing to approve the original application for nonprescription sales, the agency violated women’s rights to equal protection and privacy as guaranteed by the U.S. Constitution. A favorable judgment would compel the FDA to approve over-the-counter sales of Plan B for women of all ages.

References

  1. Kim Dixon, “Court Dismisses Suit on Barr’s Plan B Pill,” Reuters, 4 March 2008, accessed 7 March 2008, http://www.reuters.com/article/rbssHealthcareNews/idUSWAT00903820080304?pageNumber=1&virtualBrandChannel=0.
  2. Food and Drug Administration, “FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older,” Press Release published 24 August 2006, accessed 24 July 2007  http://www.fda.gov/bbs/topics/NEWS/2006/NEW01436.html.
  3. Rob Stein, “Plan B Use Surges, And So Does Controversy,” Washington Post, 13 July 2007, accessed 23 July 2007, http://www.washingtonpost.com/wp-dyn/content/article/2007/07/12/AR2007071202146.html.
  4. Ibid.
  5. Ibid.

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