Conservative pro-family groups have filed a lawsuit in the U.S. District Court against the Food and Drug Administration less than a year after the over-the-counter version of the "Plan B" morning-after pill was made readily available to women 18 and older at pharmacies nationwide.
Among its many complaints, the lawsuit filed on Thursday charged the FDA decision to approve the morning-after pill for over-the-counter use of having been made under political pressures from Democratic Senators Hilary Clinton of New York and Patty Murray of Washington.
"The FDA buckled to pressure to do something it has never done before – make a high dose of a drug available without a prescription when a low dose of the same things requires a prescription," expressed Wendy Wright, president of Concerned Women for America (CWA), in a press release Friday. "The agency skirted laws and regulations put in place to ensure drugs are safe and effective, relenting under undue pressure from political operatives."
The lawsuit - filed by CWA, the American Association of Physicians and Surgeons (AAPS), Family Research Council (FRC) and Safe Drugs for Women - seeks to reverse the FDA's decision by placing Plan B back as a prescription-only drug. From there the suit seeks to require a rulemaking procedure to address the legal questions raised.
"An agency charged with protecting the health interests of the country, must hold itself to high standards of accountability and resist those who seek to politicize women's health," commented FRC President Tony Perkins in a press release. According to FRC, the sudden reversal by FDA and then-acting FDA Commissioner Andrew C. von Eschenbach had the distinct appearance of resulting from improper political pressure exerted by Senators Clinton and Murray who made clear that they put "holds" on von Eschenbach's confirmation until he acted on Plan B.
"[T]he FDA sacrificed women's health and committed unprecedented violations of the law by approving the morning-after pill for over-the-counter use," Perkins stated.
Trials held to test how well consumers understood Plan B's label directions showed that about one-third of women of all ages did not understand that the emergency contraceptive pill cannot be used as a regular form of birth control, according to the recent report by CWA.
CWA calls the label misleading because it does not provide the legally required disclaimers to explain to women what it can and cannot do. This makes Plan B particularly unsafe for young women and girls because they do not understand that Plan B does not replace traditional and more effective birth control, and may take it too often.
Pro-family groups in the lawsuit also criticized the FDA approval for ensuring that girls will have unsupervised access to Plan B even though the FDA has found that Plan B is unsafe for girls without medical supervision, as denoted by the fact it is prescription-only for those under 18. They also allege that the FDA failed to require Plan B's owner to comply with the Pediatric Research Equity Act which protects children and adolescents.
According to Reuters, FDA spokeswoman Susan Cruzan said the agency does not comment on lawsuits.
Christian Post reporter Eric Young in Washington contributed to this report.