Regarding Plan B …

May 19, 2009 – 1:23 pm by Joshua Slatko

Due to real estate constraints, we can’t always include every interesting article that we want in the paper issue of Med Ad News. The article below didn’t quite make the cut for May’s Sales & Marketing department. But I thought it was interesting, both for the rebuke of FDA and the fact that a party other than the marketer was driving efforts for indication expansion. 

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Court requires expansion of Plan B availability

In an unusual rebuke of FDA, the U.S. District Court for the Eastern District of New York has rejected the agency’s decision to limit over-the-counter access to the emergency contraceptive Plan B to women 18 years old and older, ruling that FDA’s determination was based on politics and ideology, rather than science. The court has ordered the agency to reconsider its decision. It also ordered FDA to act within 30 days to extend over-the-counter access – which is currently limited to 18 year olds and older – to 17 year olds. 

   “Today’s ruling is a tremendous victory for all Americans who expect the government to safeguard public health,” says Nancy Northup, president of the Center for Reproductive Rights, which brought the suit against FDA. “The message is clear – the FDA should put medical science first and leave politics at the lab door. We are encouraged that the agency, now under new leadership, will take that message to heart.”

   The Center for Reproductive Rights sued FDA in 2005 for failing to grant over-the-counter status to Plan B against the advice of scientific experts and in violation of its own procedures and regulations. In 2006, FDA agreed to make Plan B available without a prescription, but only to women 18 years old and older and only behind the pharmacy counter. The Center continued to pursue its lawsuit, to ensure that Plan B would be granted true over-the-counter status and made available to all women, including young women who might benefit most from this form of contraception.

   “According to FDA’s own rules, the only legitimate criteria for making a drug available without a prescription are safety and efficacy,” Ms. Northrup says. “Emergency contraception is proven safe and effective, and today, women – including young women for whom the barriers and the benefits are so great – are one step closer to having the access they need and deserve.”

   In its ruling, the district court found that FDA “acted in bad faith and in response to political pressure,” “departed in significant ways from the agency’s normal procedures,” and engaged in “repeated and unreasonable delays.” In addition, the court found that FDA’s justification for denying over-the-counter access to 17 year olds “lacks all credibility,” and was based on “fanciful and wholly unsubstantiated ‘enforcement’ concerns.” 

   Before its action on Plan B, FDA had never restricted a non-prescription drug based on a person’s age, nor had the Bush Administration ever been consulted by FDA about an over-the-counter drug application. Depositions of senior FDA officials by the Center in 2006 indicated that the Bush Administration sought to unduly influence the agency during the Plan B application review process. Testimony also indicated that officials involved in the decision-making process were concerned about losing their jobs if they did not follow the Administration’s political directives.

   Other evidence uncovered during the lawsuit showed that the agency repeatedly departed from its own established procedures during the FDA case, from filling the reproductive health committee with political “operatives” to making a decision to reject over-the-counter access to Plan B before completion of the standard review. 

   The Center’s battle to make Plan B available over the counter to women of all ages began in 2001, when the organization filed a citizens’ petition with FDA on behalf of more than 70 medical and public health organizations to grand the drug over-the-counter status. Jan. 21, 2005, the Center filed in the U.S. District Court for the Eastern District of New York on behalf of the Association of Reproductive Health Professionals; National Latina Institute for Reproductive Health; individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy; and parents seeking over-the-counter access for their daughters. March 30, 2007, the Center asked for summary judgment in the case, arguing that the evidence gathered during discovery made it unnecessary for the court to hold a trial and that the court should order the agency to make Plan B available without a prescription to all women. 

   Duramed Pharmaceuticals Inc., Plan B’s marketer, did not participate in the suit, but the company’s leaders are pleased with its outcome and are prepared to support the ruling. “While we did not file the citizens’ petition, the company believes that timely access to Plan B is extremely important, as the sooner Plan B is taken the more effective it is,” says Denise Bradley, senior director, North America corporate communications, Teva Pharmaceuticals (tevausa.com), the parent company of Duramed. “We will work closely with the FDA to ensure that all provisions of this decision are met.”

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A postscript: on April 22, not long after this story was written, FDA announced that it would not be appealing the court’s decision and that Duramed could, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.

Tags: contraception, Duramed, FDA, Plan B, Teva