Easy Access, or Not.
Supermarkets and mass-market retailers tackle how to handle emergency contraceptives on the shelf.
It's been a rocky and controversial road in getting emergency contraceptive (EC) Plan B One-Step (levonorgestrel) from Teva Women's Health to retailers' shelves with no age or point-of-sales restrictions.
Back in late 2011, Department of Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled the U.S. Food and Drug Administration (FDA) in granting Teva's drug application for over-the-counter sales of Plan B One-Step without age restrictions. Her rationale was based on use and label comprehensive for girls 16 and younger. This past April, a U.S. District Court judge in New York ruled against Sebelius, noting FDA's acknowledgement that Plan B's "safety and efficacy in the pediatric population have been established."
After years of wrangling to lower the age bar and gain access to retailers' shelves, Teva Women's Health, a subsidiary of Israel-based Teva Pharmaceutical Industries Ltd., also got three-year exclusivity for Plan B One-Step, which expires on April 30, 2016, based on submission of clinical trial data. Plan B One-Step will be the only emergency contraceptive available with unrestricted sales on the shelf.
Other emergency contraceptives -- Next Choice (Watson Pharmaceuticals Inc.), My Way (GAVIS Pharmaceuticals LLC), two-tablet Levonorgestrel (Perrigo Pharmaceuticals Inc.) and Ella (Watson) -- will be sold either by prescription or have dual status of prescription and OTC with age restrictions. FDA allows less expensive generic versions of EC to be sold without a prescription, but those will only be available to females age 17 and older for the next three years, after which the restrictions will lapse.
Generic versions of the morning-after pill are said to cost about $10 less than Plan B. Under the new regulations, generic versions of single-pill EC may be stocked on the shelf, but will require women to present identification proving they're at least 17 to buy them.
EC poses challenges and confusion for retailers and consumers in the aisles. Case in point: On a trip to a newly reset CVS store in the Northeast, Plan B was found in the feminine health and male adult section at the end of the condom aisle on the top shelf. The product was encased in a Plexiglas locked box with one unit inside. A visit back to the store several days later found the plastic box empty with no product inside, forcing a customer to ask a clerk or go to the pharmacy.
Retailers, including supermarket chains with combo drug stores, have to decide how to merchandise an item that is controversial in some marketplaces, and retails for about $50. Jim Wisner, president of Libertyville, Ill.-based Wisner Marketing Group, who has worked on FDA compliance for a client that markets the hormone levonorgestrel, says retailers face a "confused patchwork" when it comes to EC merchandising and age compliance.
There' also the issue of high-ticket item pilferage. While the CVS store attempts to merchandise Plan B from a locked box, others might sell it like original Sudafed, which contains the ingredient psudoephedrine, with a shelf card to be taken to the pharmacy where the drug is sold, or merchandise it like Nicoderm smoking-cessation products -- under lock and key. Some won't put it on the shelf at all, because "they feel it is too sensitive a product," notes Wisner, "and some have decided not to carry it, which creates a problem on both sides."
He adds: "You have a very expensive product. How do we make it available without making it so hard to get that you can't get it?"
Plan B, the first emergency contraceptive to go OTC, is a single-dose pill that's effective in decreasing the chance of pregnancy if taken within three days after unprotected sex. The drug was first approved in 2009 for use without a prescription for women age 17 and older. Those younger than 17 could obtain the drug only by prescription. It's still too early to know how Plan B's new unrestricted status will affect sales.
Parsippany, N.J.-based researcher Kline & Co. tracks manufacturer sales, which are about 30 percent lower than retail sales, notes Laura Mahecha, the company's health care manager. Kline valued the OTC female contraceptive market at $187 million in 2012, up 4.5 percent. Of the total market, Plan B One-Step represents a big share, with $140 million in manufacturer sales, up 6.1 percent. Private label totaled $30 million, up 20 percent, representing about 16 percent of the segment. Mahecha observes that private label benefited from Plan B One-Step's loss of exclusivity for a period in July 2012.
She concedes there might be some growth with Plan B's new status, but adds, "The incidence of people needing a contraceptive isn't going to increase tremendously because stores put it on the shelf in reproductive health.
"The rules on [EC] have flip-flopped depending on the political administration. Regardless of the official rules, retailers will ultimately decide, and it's not like they have a vast amount of space where they can bring it out from behind the counter, despite the change in the rule."
As for distribution, supermarkets represent just 5 percent of all female contraceptive products, according to Kline, while the drug channel captures 70 percent of the market. Mass merchants represent 23 percent, and 2 percent is represented by others.
Wisner, however, believes that after Plan B's three-year exclusivity expires, all EC will be competing on the shelf.
The next chapter in the evolving saga of female contraceptives might be oral prescription pills going OTC.
"I am hearing chatter on oral contraceptives and whether FDA might approve a switch of them," says Mahecha, explaining that there appears to be a mindset shift at FDA, which is now more open to innovative applications of switches.
"You have a very expensive product. How do we make it available without making it so hard to get that you can't get it?"
--Jim Wisner, Wisner Marketing Group