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FDA approves Teva’s one-pill emergency contraceptive

BY Michael Johnsen

Teva Pharmaceuticals last month gained Food and Drug Administration approval for its Plan B One-Step, a line extension of the emergency contraceptive that changes the two-pill regimen associated with Plan B to just one pill.

OTC availability for women age 17 years old is new as well—a federal judge ordered the FDA to lower the OTC age limit for Plan B from 18 years to 17 years in April, though the agency noted it would need a new drug application from Teva in order to accomplish that. Plan B One-Step will begin shipping by August, Teva reported.

“I prefer one-pill dosing for my patients because it allows them to act more quickly, while providing a high level of safety and efficacy,” said Ashlesha Patel, division director of Family Planning Services at John H. Stroger Jr., Hospital. “Emergency contraception is more effective the sooner it’s taken, and Plan B One-Step provides a back-up plan that’s just one pill away.”

Awareness of Plan B has increased significantly since OTC approval in 2006, Teva reported. More than 88% of 18- to 30-year-olds categorize Plan B as emergency contraception, up from 64% in 2006. And 86% of individuals understand that the product prevents, rather than terminates, pregnancy, unlike the prescription “abortion pill” RU-486.

Additionally, U.S. retail pharmacists are overwhelmingly compliant with dispensing guidelines. Within one year post-OTC approval, 99% of pharmacists who sold Plan B were aware of its dual-label status—it’s prescription-only for women younger than 17—and 95% were comfortable selling/dispensing Plan B.

Teva’s original Plan B formulation was opened to generic competition last month, as Watson Labs obtained approval for its Next Choice levonorgestrel brand, though only as a prescription for women younger than 17. Teva has patent protection on the OTC indication through Aug. 24.

For the 12 months ended March 2009, Plan B had total U.S. sales of approximately $123 million, of which approximately 10% are attributable to prescription sales, Watson reported, citing IMS sales data.

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Washington, Mo., considers repealing recently passed PSE legislation

BY DSN STAFF

NEW YORK The objective here is closing down clandestine methamphetamine labs. The question is: Who is going to bear the cost? And the answer, ultimately, is the consumer.

It seems that one of the primary reasons behind legislation like this, which is also under consideration by the California state legislature as well as several local municipalities throughout Missouri, is cost shifting.

Indeed, one solution that would prevent the practice of “smurfing,” a practice whereby meth addicts exceed their legal purchase limits in pseudoephedrine products by buying across several nearby pharmacies, is electronic logbooking. By granting access to PSE logbooks to law enforcement in real time, law enforcement officers would not only be made aware of a “smurfer” as they were driving between pharmacies, but would also identify who that smurfer was and where they lived.

Setting up that comprehensive electronic logbooking system requires resources, however. State coffers have traditionally been tapped for that purpose, and at least in the case of California, the Consumer Healthcare Products Association has offered to help defray that cost. In the case of Missouri, more than $500,000 has already been earmarked for the implementation of an electronic logbooking system at the state level.

However,  a not-as-much-talked-about cost is also borne by law enforcement, as pointed out by Franklin County Sgt. Jason Grellner in Missouri. After all, it requires additional resources to actually apprehend and prosecute those criminals, he suggested. And a system that better defines who those criminals may be, by his estimation, could cost the state as much as $350,000 per criminal per year.

Therefore, Grellner argues, it’s a fiscal responsibility to take PSE off the OTC market altogether, and require a prescription for the popular decongestant.

That, in a nutshell, is cost-shifting. Because reverse switching PSE translates into less revenue for retailers (and consequently less taxable revenue, as well) for those consumers who choose to forego PSE-provided relief, and for those who don’t, it’s a greater healthcare cost because now consumers have to schedule an appointment with their primary care practitioner and pay the co-pay for that doctor’s visit on top of the cost of the PSE product.

Regardless of how the consumer ultimately pays for the elimination of meth labs — whether through increased taxes to cover escalating law enforcement budgets or through increased personal healthcare costs — there is another argument to be made here. Switching PSE to prescription-only status may result in fewer meth labs busted, but it’s not going to do anything about those meth addicts still on the street. Necessity is the mother of invention, and for addicts, that simply means sourcing their meth from somewhere else.

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