Originally posted at Hunter of Justice on December 14, 2011.
The Center for Reproductive Rights announced Tuesday that it will reopen a lawsuit filed in 2005 in order to challenge unnecessary age restrictions on emergency contraceptives imposed last week by the Obama administration. The lawsuit - Tummino v. von Hamburg - was originally filed against the FDA. At a hearing on Tuesday, U.S. District Judge Edward Korman invited the Center to refile and expand the case in order to contest the action by U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius overruling the FDA’s recent approval of "Plan B" contraceptives.
According to AP:
...[Judge] Korman was highly critical of the government's handling of the issue when he ordered the FDA two years ago to let 17-year-olds obtain the medication. At the time, he accused the government of letting "political considerations, delays and implausible justifications for decision-making" cloud the approval process. On Tuesday, he said "it seems to me like we're going through a re-run."
In deciding to limit the over-the-counter availability of the drug, Sebelius said she had concluded that the data submitted for the pill did not establish that prescription dispensing requirements should be eliminated for all ages. She said the studies submitted to the government did not include data on all ages...
Korman repeatedly questioned the lawyer for the government on whether the study data included information on girls older than the youngest girls of reproductive age but younger than the 17-year-olds currently able to get the pill, and whether they would be able to understand the pill instructions and use it properly. Assistant U.S. Attorney Scott Landau said he couldn't answer that question, both because it was proprietary information and because the issue hadn't actually been raised for the court to rule on.
In his 2009 decision ordering the FDA to reconsider the position it had taken in 2003 that access must be available by prescription only to girls 17 and older, Judge Korman found that the agency under the Bush Administration had "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 the 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."
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.