FDA's decision to approve emergency contraceptive Plan B for over-the-counter sale to women age 18 and older cracks open the door on a pharmacy-only, behind-the-counter model for nonprescription drug sales.

The drug will be sold behind pharmacy counters, and will remain prescription-only for women age 17 and under.

Sponsor Barr's plan for ensuring the OTC version will be sold only by licensed pharmacists, as required under the approval, will be closely watched as a template for a new pharmacy-counter approach to marketing nonprescription drug products.

The decision demonstrates flexibility within the existing regulatory system for switch sponsors of drugs that require an intermediate level of supervision between prescription status and traditional OTC sale.

Center for Drug Evaluation & Research Director Steven Galson was cautious in characterizing the behind-the-counter/dual status approach as a precedent during an Aug. 24 press conference.

"Every product is different; this is not meant as a precedent," Galson said. "But it is interesting to me and to the agency that we are trying something different with this product."

"We'll have to evaluate every application that comes to us," Galson said. "But this did provide an opportunity for this type of access that we thought was really consistent with what was needed for this product."

However, the approval indicates the agency's willingness to work with a behind-the-counter sale restriction as a condition of approval.

In the approval letter released Aug. 24, the agency agreed to 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, and will not be sold at gas stations or convenience stores, FDA notes in the approval letter. Pharmacies will keep Plan B behind the counter, the agency states.

Plan B will be available in the same packaging for both OTC and Rx sale; Rx labeling can be attached to the package sold under a prescription, Barr said in a release. The common package will carry the phrase "Rx only for age 17 and younger" on the main display panel.

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.

CARE includes a tracking program that will allow Barr to determine if stores are in compliance with the age restriction through the use of "anonymous shoppers" and other monitoring efforts.

The American Pharmacists Association applauded FDA's "novel approach" by bringing pharmacists into the equation to help counsel consumers on appropriate selection and use.

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 of more than $30 mil., according to Barr.

The Plan B approval clears a major hurdle for FDA Acting Commissioner Andrew von Eschenbach's nomination to the permanent commissioner post. Democratic Senators Hillary Clinton (N.Y) and Patty Murray (Wash.) held a same day press conference to release their hold on the nominee.

However, the approval may make von Eschenbach vulnerable to a hold from conservatives. At least one senator has been rumored to be considering a hold in light of the decision, according to a Health Committee staffer.

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

The age restriction remains a contentious issue for many supporters of the switch.

In an Aug. 23 memo from the acting commissioner, the agency justified 18 as 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.

"We still feel that Plan B should be available to a broader age group without a prescription," Downey said, although he said the firm is pleased with the decision.

Barr plans to conduct research in support of a lower age threshold for OTC sale.

Clinton urged FDA to "revisit" the age restriction in statements during her press conference.

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 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 finding Barr's original switch sNDA "not approvable" was arbitrary and capricious (¹ Also see "FDA Memo Sheds Light On Plan B Discussions" - Pink Sheet, 31 January, 2005., p. 7).

CRR's suit has been amended, and the firm seeks 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, 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 "Plan B Behind-The-Counter Status Discouraged By Panel Members" - Pink Sheet, 22 December, 2003., p. 3).

- ³ Christopher Walker

Plan B Pioneers OTC “Pharmacy Counter” Approval, Dual-Status Marketing

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