June 12, 2013 — Several medical and women's rights groups on Tuesday expressed concern that the federal government's decision to allow nonprescription sales of the emergency contraceptive Plan B One-Step without age restrictions would not improve access to generic versions, CQ Roll Call reports (Ethridge, CQ Roll Call, 6/11).
The Department of Justice on Monday said it would comply with U.S. District Judge Edward Korman's April ruling to make Plan B One-Step available without age or point-of-sale restrictions.
However, Korman -- who must sign off on DOJ's plan of compliance -- said in the ruling that restrictions should be lifted on all EC drugs, partly because he did not want to disproportionately burden low-income and minority individuals with barriers to access (Neergaard, AP/Sacramento Bee, 6/11).
DOJ's Plan of Compliance
In its letter to Korman on Monday, DOJ stated that "FDA will not at this time take steps to change the approval status of" the generic versions or an older, two-pill version of Plan B, adding that the agency believes there are "significant differences" between the one-dose and two-dose versions of the drug.
FDA also might grant market exclusivity to Plan B One-Step's manufacturer -- Teva Pharmaceuticals -- a decision that "may affect the labeling that could be approved for generic equivalents," DOJ said.
Even if Korman accepts the plan of compliance, Plan B One-Step would not be available over-the-counter immediately because Teva would still need to submit a new drug application to FDA (CQ Roll Call, 6/11).
Reproductive Health Experts Cite Price, Access Concerns
Susannah Baruch -- interim president and CEO of the Reproductive Health Technologies Project -- noted that Plan-B One-Step retails for between $40 and $50. "[G]enerics tend to be $10 to $20 cheaper than the name brand, and that can make all the difference for many women," she said (Rovner, "Shots," NPR, 6/11).
Amy Allina -- program and policy director at the National Women's Health Network -- said granting Teva market exclusivity would also be problematic. "Restrictions that were created for political reasons should not remain in place for business reasons," she said.
Nancy Northup -- president of the Center for Reproductive Rights -- said the government is trying to justify continued restrictions on some EC products by claiming they are different, which she said it would need to back with scientific evidence in court (CQ Roll Call, 6/11).
"The government has been trying to argue for years that there's a distinction, and the evidence in the record is that the two-pill product is safe and effective and should be on the drugstore shelves," Northup said.
The Obama administration said it has continued concerns about the ability of younger teens to appropriately use the two-pill version. In explaining the decision to lift restrictions only on Plan B One-Step, White House spokesperson Jay Carney said it is "because at the very least that addresses some of the concerns about the ability of younger girls to use that medication" ("Shots," NPR, 6/11).
Separately, Janet Woodcock -- director of FDA's Center for Drug Evaluation and Research -- said in a letter to CRR that because "[t]here are fewer data available regarding the actual use of Plan B as a nonprescription product by younger adolescents, ... FDA therefore believes it is appropriate and consistent with the court's order to comply by making only [Plan B One-Step] (and not the two-pill product) available OTC."
Meanwhile, physician groups praised the decision to lift restrictions on Plan B One-Step but urged the administration to make all EC products available OTC.
"For pediatricians, the science has always been clear: emergency contraception is a safe, effective tool to prevent unintended pregnancy in adolescents of any reproductive age," American Academy of Pediatrics President Thomas McInerny said in a joint statement from AAP, the Society for Adolescent Health and Medicine and the American Congress of Obstetricians and Gynecologists (Pittman, MedPage Today, 6/11).