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White House Positions on Contraceptives Fuel Controversy on All Sides Cont.
“The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about 10% of girls are physically capable of bearing children by 11.1 years of age,” Sebelius said. “It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.”
In a letter to FDA Commissioner Margaret Hamburg, MD, Sebelius ordered FDA to issue a denial letter for the application. In both the letter and her public statement, Sebelius quoted from the Federal Food, Drug and Cosmetic Act that states that the HHS Secretary, through the FDA Commissioner, shall be responsible for executing the provisions of the act.
President Obama expressed his support for Sebelius’ decision at a press briefing the following day. “As I understand it, the reason Kathleen made this decision was she could not be confident that a 10 year old or an 11 year old going into a drugstore, would be able to, alongside bubble gum or batteries ,… buy a medication that, potentially, if not used properly, could end up having an adverse effect,” Obama said. “And I think most parents would probably feel the same way. “Obama did, however, stress that the decision to overrule the FDA was made by Sebelius and not the White House. This suggests that the president is aware of the convoluted history that the prior administration had with Plan B.
The drug was first approved for prescription use in 1999. In 2003, Barr Laboratories — the original marketer of the Rx Plan B — submitted an application to switch the drug to OTC status. In December that year, an FDA advisory committee voted 23 to 4 in favor of making Plan B OTC.
Instead of taking the usual 90 days to make a final decision, FDA delayed until May 2004, rejecting the application on the grounds that there was a lack of data for patients 16 and younger. At the time, there were reports of pressure from a conservative White House for FDA officials to deny the application.
In June 2004, Congress requested a report on the FDA decision. The report ultimately found that the decision was highly unusual and could have been the result of pressure from the Bush Administration.
In the meantime, Barr submitted an amended application to make Plan B prescription-only for women 16 and younger and OTC otherwise. Intense political maneuvering followed the July 2004 application. FDA delayed making a decision for more than a year, and legislators threatened to obstruct a Senate vote on confirmation of Lester Crawford as FDA commissioner until a decision was made.
In order to get Crawford approved, FDA announced in August 2005 that Plan B was safe for OTC use by women older than 16. However, the agency delayed making an official approval citing packaging and age-enforcement concerns. FDA delayed for nearly a year, and it was more legislative pressure — this time against Crawford’s successor — which forced the agency to move on the issue.
In July 2006, the day before his confirmation hearing, Acting FDA Commissioner Andrew Eschenbach invited Barr Labs to resubmit its application, changing the OTC age restriction from 17 and older to 18 and older. Barr did so the following month, and FDA approved the application immediately, making Plan B available OTC to consumers 18 and older.
Family planning advocates filed a lawsuit against FDA in federal court, arguing that FDA’s decisions had been based not on science but on political pressure, thus were a violation of the public trust.
In March 2009, District Judge Edward Korman came down in favor of the plaintiffs. In his written decision on the case, Korman said, “The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons and, on two occasions, only took action on Plan B to facilitate confirmation of Acting FDA Commissioners, whose confirmation hearings had been held up due to these repeated delays.”
“FDA upper management, including the commissioner, wrested control over the decision-making on Plan B from staff that normally would issue the final decision on an OTC switch application,” Korman wrote. “The commissioner — at the behest of political actors — decided to deny nonprescription access to women 16 and younger before FDA scientific review staff had completed their reviews.”
In light of those findings — which included that FDA officials and staff had agreed that 17 year olds could use Plan B safely without a prescription — Korman ordered FDA to make Plan B available OTC for consumers 17 years and older.
Whether this latest example of an FDA review decision being overturned by officials higher up the food chain will lead to more controversy is unknown. Teva Pharmaceutical Industries Limited released a statement following Sebelius’s decision, saying the company commended FDA for its decision to recommend OTC status and was disappointed by the actions of HHS.
Sebelius later said that Teva can resubmit an application with more testing for label comprehension and use among girls at younger reproductive ages.
In terms of health insurance coverage for contraceptives, a lawsuit appears likely.
Dolan urged that the HHS mandate be overturned, saying, “The Obama administration has now drawn an unprecedented line in the sand.The Catholic bishops are committed to working with our fellow Americans to reform the law and change this unjust regulation. We will continue to study all the implications of this troubling decision.”
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