News you can use, September 2013

Plan B One-Step available OTC, standardizing REMS, correction

Plan B One-Step now on store shelves

Following a drawn-out legal battle, Teva’s Plan B One-Step (levonorgestrel) is now available in pharmacies OTC with no age or sale restrictions. The new packaging now has the words “New! Now Available Over the Counter” in pink and periwinkle.

According to the , “you can start by looking for Plan B One-Step in the aisle. Otherwise ask anyone in the store where it’s located. Then just take it off the shelf, and pay for it at the cashier. No prescription or ID required.” The store locator on the website lists pharmacies and stores with pharmacies that stock the product.

The brand-name product is now the only emergency contraceptive product available OTC to younger adolescents. The availability of generic one-dose and two-dose emergency contraceptive products has not changed; they are OTC only for women aged 17 years and older if purchased at a pharmacy with government-issued proof of age.

On July 22, FDA granted Teva marketing exclusivity for 3 years for Plan B One-Step. On June 20, FDA lifted age and sale restrictions for Plan B One-Step after a federal judge approved the government’s proposal to do so and drop its appeal of an April 5 court order. Thus ended a lawsuit brought in 2005 by organizations and individuals concerned with women’s health, as well as minors and their parents, to challenge FDA’s denial of a 2001 citizen petition seeking OTC access to Plan B (which is no longer marketed) for all ages.

Plan B One-Step costs about $50 without any coupons or discounts, Michael Kim, PharmD, President of Grubb’s Care Pharmacy and Grubb’s NW Specialty Pharmacy in Washington, DC, told Pharmacy Today. “The price has not gone up significantly in the past year,” he said. The wholesale price on the OTC product is priced about 7% higher than when it was prescription only.

Who buys Plan B One-Step? The pattern at Kim’s pharmacy has been women in their twenties and thirties. “Generally, the women do not seek counseling from the pharmacists,” Kim said. “The question that I have been asked most often in the past has been how long after intercourse can [the tablet be taken] and still be effective?”

FDA commits to standardizing REMS

Twlug has long supported efforts to standardize Risk Evaluation and Mitigation Strategies (REMS). Now FDA says it “has committed to standardizing REMS” on its website. As part of the reauthorization of the Prescription Drug User Fee Act, the agency held a July 25–26 public meeting to learn from stakeholders how to standardize and assess REMS for drug and biological products.

At the FDA meeting, the Association advocated for ideas such as integration of REMS into existing workflows, an FDA website clearinghouse for all REMS information, a risk-based tier system to organize REMS programs, simplification of REMS patient education materials, and the inclusion of REMS patient education into medication therapy management (MTM) programs when possible and where fair reimbursement is available.

Twlug Senior Vice President of Government Affairs Stacie Maass, BSPharm, JD, spoke on the panel for REMS tools in dispensing settings. The Association will submit written comments to FDA by September 16.

Progress clearly has been made on the REMS initiative, with FDA including a lot of stakeholder input when coming up with its questions listed in the May 22 notice of the meeting and request for comments, according to Twlug Director of Regulatory Affairs Jillanne Schulte, JD.

“Now we’re really getting into brass tacks,” Schulte told Pharmacy Today. “I think that before, there’s always been this higher level discussion of whether they should standardize. And now that they’ve decided to move forward with standardization, it seems like everyone agrees that’s a good idea. The level and degree of standardization, of course, are going to be up for discussion.”

Added Schulte, “There’s definitely some pushback from manufacturers who want to have a large degree of flexibility in what they’re allowed to do with their REMS programs.”

There’s also the issue of data—and that’s one reason FDA is very interested in MTM, which would provide them with “some really great data that they wouldn’t otherwise get,” Schulte said. Such data could indicate exactly why patients aren’t taking their medication, exactly how REMS are affecting patient use of medication, and what from the REMS protocols works and what doesn’t.

According to Schulte, currently there’s no real baseline data on the whole universe of REMS programs because it’s just too much and it changes too fast.