FDA's decision to approve the emergency contraceptive Plan B for over-the-counter sale to women age 18 and older opens the door to a vote on FDA Acting Commissioner Andrew von Eschenbach's nomination to the permanent post.

Democratic Senators Hillary Clinton (N.Y) and Patty Murray (Wash.) held a press conference following the approval Aug. 24 announcing release of their hold on the nominee.

The two senators previously stood by their hold despite the agency's recent announcement that it was taking steps toward approval (¹ Also see "FDA’s Plan B Plan Fails To Appease Von Eschenbach Blockers" - Pink Sheet, 7 August, 2006., p. 13).

The approval, however, may leave von Eschenbach vulnerable to attack from the opposite side of the political spectrum. At least one senator has been rumored to be considering a hold in light of the decision, according to a Senate Health Committee staffer.

Committee Chairman Mike Enzi (R-Wyo.) has not yet scheduled a vote on the nominee, but he is currently reviewing the approval decision and gauging committee members' reactions to it.

The approval for Plan B to be sold behind pharmacy counters without a prescription but remain prescription-only for women under 18 includes Barr's proposed Convenient Access Responsible Education (CARE) program, which outlines distribution, education and monitoring of sales.

"The sponsor and third party distributors, wholesalers and chain drug companies will only distribute Plan B to licensed pharmacies or other licensed healthcare clinics" under CARE, the approval letter states.

The pharmacy setting will allow "pharmacists and other healthcare providers to properly restrict OTC access to those age 18 years and older," Barr's CARE plan notes.

Barr intends to launch the dual status version of Plan B by the end of the calendar year. The firm has not revealed planned OTC pricing, but current prescription pricing falls in the $25 to $40 dollar range.

CEO Bruce Downey has predicted that sales could double within a year. The prescription product currently pulls in annual sales over $30 mil., according to Barr.

While paving the way for approval, the age restriction still remains a contentious issue for supporters of the switch.

While Clinton called the approval a "critical step in restoring the faith of the American people in the FDA by demonstrating that this agency will return to its original mission of putting science before ideology," the senator also urged FDA to "revisit" the age restriction.

In an Aug. 23 memo from the acting commissioner, the agency justified the threshold age by stressing that pharmacies "are more familiar with 18 as a cutoff age" than 17. Previously, FDA identified 17 as the appropriate age for self-selection.

Although Downey said the firm is pleased with the decision, he also said, "we still feel that Plan B should be available to a broader age group without a prescription." Barr plans to conduct research in support of a lower age threshold for OTC sale.

The Center for Reproductive Rights, which has sued FDA over delays in the Plan B review process, deemed the approval a denial of "true over-the-counter access," citing the age limit and the behind-the-counter status.

CRR filed its suit in early 2005, claiming that FDA's decision that Barr's original switch sNDA was "not approvable" was arbitrary and capricious. CRR subsequently amended the suit to seek approval of the drug without an age restriction.

FDA's approval closes a major chapter in the politically charged and complex regulatory history of the drug.

Women's Capital Corporation filed the initial switch application in April 2003 and then sold the product to Barr later that year.

A joint nonprescription drugs/reproductive health drugs advisory panel supported OTC status in a 23-4 vote in December 2003. In discussions, a majority of those panelists also recommended against behind the counter restrictions (² Also see "Barr Plan B OTC Should Not Be Kept Behind Pharmacy Counter, Cmte. Says" - Pink Sheet, 22 December, 2003., p. 16).

Plan B Approval Clears The Way For Von Eschenbach Confirmation

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