Has Court Action Already Commenced in the Plan B Expansion Matter?

As you probably heard, on December 7, 2011, in a precedent setting action, the Secretary HHS, Kathleen Sebelius, over-ruled an approval decision of the federal Food and Drug Administration (FDA) and directed the agency to issue a response letter denying a supplemental new drug application (NDA) which sought to make the Plan B One-Step contraceptive available over-the-counter (OTC) to all women of reproductive age.  The contraceptive, commonly referred to as the “morning-after pill” is currently approved for OTC use by women 17 and over and is available by prescription for women under 16.

Criticism of HHS’ Decision

Criticism of the HHS decision began immediately. For example, on December 8, 2011, Dr. Jacques Moritz, a Medical Contributor for ABC’s Healthy Living, bluntly stated that “the FDA did its job and did it properly. . . . the OB-GYN community is scratching their heads. . . . doctors don’t like politics mixed with science, and the science here was a no-brainer.”

On December 13, 2011, 14 U.S. Senators sent a letter to Sebelius expressing their disappointment with the decision and asking that she provide them with the “specific rationale and scientific basis” for the decision.

From a strictly scientific point of view the criticism seemed reasonable enough. After all, had not the FDA’s Center for Drug Evaluation and Research (CDER) carefully considered the scientific question of whether younger females were able to understand how to use Plan B One-Step and determined “that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.”

Sebelius’ Rationale

Despite the fact that the FDA carefully considered the science, the Sebelius decision was applauded by many as not only well-reasoned but based on common sense, especially given the fact that the FDA approval could lower OTC use to girls as young as 11 years of age.

As Sebelius stated in her press release:

 . . . the switch from prescription to [OTC] [use] for this product requires that we have enough evidence to show that those who use this medicine can understand that label and use the product appropriately. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use. The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about [10] percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age.

An example of the public support for the Sebelius decision occurred on December 7, when CNN reported that Dr. Lisa Flowers, associate professor in the Department of Obstetrics and Gynecology at Emory University’s School of Medicine, said Sebelius’ decision “might be the right thing to do until we get a really good system by which we can educate young kids about prevention of pregnancy and understanding the risks of getting involved in sexual intercourse, and what are the outcomes.”  Flowers suggested the FDA consider allowing over-the-counter access for girls under the age of 17 if they are accompanied by a parent to the drugstore.

President Obama also came out in full support of the Sebelius’ decision, stating:

I will say this, as the father of two daughters.  I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.  And 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 go into a drugstore, should be able — alongside bubble gum or batteries — be able to buy a medication that potentially, if not used properly, could end up having an adverse effect.  And I think most parents would probably feel the same way.

Has Court Action Already Commenced?

Conveniently for the advocates of reproductive rights, a dormant 2005 New York U.S. District Court case, Tummino v. Von Eschenbach, could be used to challenge the HHS decision.  In Tummino, the Center for Reproductive Rights and other advocates sought judicial review with respect to certain applications requesting approval of OTC access for Plan B (then in 2 pill form), charging that the FDA’s refusal to make Plan B available OTC to women of all ages was not supported by medical or scientific evidence.

On March 23, 2009, the Tummino court ordered the FDA to permit the manufacturer to make Plan B available to 17-year-olds without a prescription. The court also remanded the case to the FDA to reconsider OTC approval for younger age groups. The FDA ultimately approved Plan B One-Step (single tablet) for OTC use for women 17 years of age or older on July 10, 2009.

A week later, on July 17, 2009, the FDA also re-opened the docket for the Center for Reproductive Right’s Citizen Petition (Docket No. 2001P-0075/CPI) to allow Tummino plaintiffs and others interested persons to submit evidence regarding the request that FDA approve Plan B for distribution to women of all ages without restriction.

On February 7, 2011, the Plan B manufacturer submitted the supplemental NDA for Plan B One-Step, seeking OTC use for all women of reproductive age. The FDA not only denied the supplemental NDA at the direction of Secretary Sebelius on December 7, 2011, but immediately thereafter, on December 12, 2011, the FDA likewise denied the Citizen Petition of the Center for Reproductive Rights.

Since these HHS decisions, according to Reuters, the judge in the Tummino case has openly questioned whether the FDA has violated his 2009 order by allowing politics to trump science. Reuters quotes judge Korman as saying: “The FDA ‘did what they thought was right…and the Secretary overruled it. Now we are dealing with the Secretary.’”

Reuters further reports:

The judge [Korman] ordered the FDA’s lawyer…to turn over whatever proof the FDA and HHS relied on in deciding that girls under the age of 17 could not properly use the drug.  When the [FDA lawyer] objected, saying the information was proprietary, Korman told him to submit a sworn statement that HHS had not ignored evidence that, for instance, girls as young as 12 might properly use Plan B. If it had ignored that evidence, Korman said, “that would be the height of arbitrariness.”

With a federal court judge already prodding the plaintiffs and chastising the government in an existing but dormant case, can FDA and HHS reconsideration of the matter (voluntarily or by court order) be far off?  Time will tell.

Tummino v. Von Eschenbach, No. CV 05-366 ERK/VVP, 427 F.Supp. 2d 212, E.D. New York, February 24, 2006.