Generic Rx Plan B Approval Points To Possible OTC Equivalents In Near Future

FDA's approval of a generic prescription-only Plan B makes a nonprescription generic of the emergency contraceptive likely, potentially as early as August.

Watson Pharmaceuticals announced June 24 the agency approved its levonorgestrel 0.75 mg molecule, under the name Next Choice , for prescription-only sale.

This development "bodes really well for a Watson generic over-the-counter Plan B," said Jennifer Rogers, acting executive director of the reproductive rights group Reproductive Health Technologies Project.

The earliest a generic non-Rx version of the emergency contraceptive can be approved is Aug. 24, when Teva Pharmaceutical Industries' OTC market exclusivity expires.

While no firm has acknowledged filing an abbreviated new drug application for an equivalent to nonprescription Plan B, the Rx and non-Rx versions are identical.

In fact, a single package is used for both the Rx and OTC versions of the branded product. Plan B is stocked behind the pharmacy counter, where it is sold without a prescription to women 18 years and older, or as an Rx drug to women under 18.

Therefore, pending labeling review and meeting existing sales restrictions, Watson's Rx approval means a nonprescription approval should be a slam-dunk.

Any applicant for generic non-Rx levonorgestrel would be subject to the same behind-the-counter and age restrictions as exist for Plan B unless FDA opts to alter the sales status for the branded drug and its equivalents (¹ (Also see "Obstetricians Predict Problems If Reproductive Drugs Go Behind The Counter" - Pink Sheet, 3 Dec, 2007.)).

FDA will soon allow non-Rx sale of Plan B to 17-year-olds, as ordered in a March court ruling (² (Also see "Plan B Lightning May Strike Again: Complying Will Not End Political Storm" - Pink Sheet, 27 Apr, 2009.)).

A 2001 citizen petition submitted by the Center for Reproductive Rights and other advocacy groups asked FDA to allow universal nonprescription availability of Plan B. The agency took five years to reject the petition but then compromised and allowed behind-the-counter access to the contraceptive to 18-year-olds.

CRR subsequently sued FDA over what many viewed as a politically skewed review process for Plan B. A group of agency scientists recently called for the removal of FDA leaders who had allowed ideology to trump science during evaluation of the OTC switch proposal (³ (Also see "FDA Scientists Say Plan B Decision-Makers At CDER “Should Be Removed”" - Pink Sheet, 6 Apr, 2009.)).

The March decision in the U.S. District Court for the Eastern District of New York said FDA's review process was arbitrarily delayed and instructed the agency to reconsider OTC access to Plan B with no age restrictions.

However, how that would work practically is unclear, since there is not a current application. Teva, which owns original Plan B sponsor Barr Labs, declined to discuss whether it will file a new application for unrestricted OTC status.

A Teva spokeswoman said the firm has submitted to FDA an application for a labeling change reflecting availability to 17-year-olds.

Rogers said RHTP is "pleased with the signals we're seeing" from FDA regarding its "recommitment to science." The project was a co-sponsor of the 2001 citizen petition seeking OTC emergency contraceptive access for women of all ages (⁴ (Also see "Emergency Contraceptives OTC Access Faces Uphill Struggle" - Pink Sheet, 19 Feb, 2001.)).

RHTP informs Commissioner Margaret Hamburg in a June 16 ⁵ letter that "there is no clinical or scientific rationale for an age restriction" on OTC Plan B sales.

Among other interested parties, RHTP's letter is co-signed by Susan Wood, who resigned as head of FDA's Office of Women's Health over the agency's handling of the Plan B switch.

Wood now teaches at The George Washington University's School of Public Health and Health Services.

- Dan Schiff ([email protected])