BROOKLYN, N.Y. (CN) - Fed up with politically inspired delays, a federal judge said Friday that there is no place for age restrictions when it comes to over-the-counter access to the emergency contraception Plan B.
"The issue in this case involves the interpretation of a general statutory and regulatory scheme relating to the approval of drugs for over-the-counter sale," U.S. District Judge Edward Korman wrote. "The standards are the same for aspirin and for contraceptives."
Plan B and Plan B One-Step are emergency contraceptives that use the synthetic hormone levonorgestrel to mimic the naturally occurring hormone progesterone as a way to interfere "with prefertilization events," according to the ruling.
Though Plan B itself is no longer marketed, generic versions are available. The FDA has approved it for nonprescription access by women 17 and older. These consumers can purchase the medication only at a pharmacy, with government-issued proof of age. All others need a prescription.
Korman noted that he ordered such access for 17-year-olds back in 2009 when he presided over the first challenge to restrictions against Plan B and all emergency contraceptives. He refused at that time, however, to order over-the-counter access regardless of age.
"I rejected this argument, although I agreed with the plaintiffs that the FDA bowed to political pressure emanating from the White House and departed from agency policy. I declined to grant the relief plaintiffs requested for two principal reasons," Korman wrote. "First, the commissioner of the FDA had resigned and his replacement, as well as a new deputy commissioner, had been nominated by the newly elected president. This change in leadership suggested that the FDA could be 'trusted to conduct a fair assessment of the scientific evidence.' Second, it was my view that the decision whether to make Plan B available without a prescription regardless of age was one that should be made by the FDA, to which Congress had entrusted the responsibility, and not by a federal district judge."
On remand, the FDA waited nearly three years to rule on the remanded citizen petition. In the meantime, Plan B's manufacturer proposed a supplemental new drug application (SNDA) that would have allowed over-the-counter access to Plan B One-Step for all ages. The FDA agreed to approve this SNDA, but Kathleen Sebelius, the secretary of Health and Human Services, intervened and ordered FDA Commissioner Margaret Hamburg to deny the application. Sebelius supported her decision by faulting the sponsor for not including data on all ages.
"This pronouncement made it impossible as a practical matter for the FDA to approve the citizen petition, because it likewise did not include such data," Korman wrote. "Indeed, the citizen petition denial came only five days later, although the FDA had sat on the citizen petition for three years."
President Barack Obama endorsed the decision in 2011, but Judge Korman found Friday that the secretary and FDA decisions were "arbitrary, capricious, and unreasonable."
"This case is not about the potential misuse of Plan B by 11-year-olds," the 59-page opinion states. "These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed. Instead, the invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions."
Korman noted that controversy surrounds the case "because it involves access to emergency contraception for adolescents who should not be engaging in conduct that necessitates the use of such drugs and because of the scientifically unsupported speculation that the drug could interfere with implantation of fertilized eggs."
Turning to the legal issues, Korman slammed the denied SNDA and citizen petition as "unexplained departures from a number of established policies and practices."
"As I have previously observed, the obstructions in the path of those adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the-counter regime have the practical effect of making the contraceptives unavailable without a doctor's prescription," the ruling concludes. "Consequently, the decision of the FDA denying the Citizen Petition is reversed, and the case is remanded to the FDA with the instruction to grant the Citizen Petition and make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days. On remand, the FDA may determine whether any new labeling is reasonably necessary. Moreover, if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product."
Korman also noted that "bad faith that has permeated consideration of the citizen petition, not to speak of the Plan B sponsor's applications."
"More than twelve years have passed since the Citizen Petition was filed and eight years since this lawsuit commenced," he continued. "The FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster. Moreover, one of the devices the FDA has employed to stall proceedings was to seek public comment on whether or not it needed to engage in rulemaking in order to adopt an age-restricted marketing regime. After eating up eleven months, 47,000 public comments, and hundreds of thousands, if not millions, of dollars, it decided that it did not need rulemaking after all. The plaintiffs should not be forced to endure, nor should the agency's misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction."
In a separate order, Korman addressed the motion of Teva Women's Health to "intervene in support of neither party and for the limited purpose of defending its statutory right to marketing exclusivity."
He called this demand "fundamentally illogical."
"I have no power to grant a period of exclusivity," the four-page order states. "Indeed, I do not have subject-matter jurisdiction to review the denial of Teva's SNDA for the purpose of granting it any relief, much less granting a period of exclusivity that only the FDA can grant when it approves an application after finding that the studies submitted by the sponsor are essential. Under these circumstances, intervention would be pointless."
Korman did grant Teva's alternative application for amicus curiae status.
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