Teva's 'morning-after' pill suffers a setback

Federal regulators nix a proposal to make the pill available without a prescription to minors.

By Benzinga Dec 7, 2011 6:09PM

By Phil Marsh, Benzinga Staff Writer

Teva Pharmaceutical (TEVA) hoped to have the first over-the-counter emergency contraceptive available to all ages Wednesday. It failed.

The U.S. Department of Health and Human Services rejected the company's application for Plan B One-Step -- known as the original morning-after pill -- to be available to consumers of all ages without a prescription. A positive verdict would have given Teva an exclusivity advantage it lost back in 2009, when a generic version of its drug hit the market.

Teva shares dropped less than 1% Wednesday to close at $39.99.

The company has consistently pushed federal regulators to increase the drug's availability, and so far it has a record of wrestling its way out of the Food and Drug Administration's hands. Since coming to market a decade ago purely as a prescription drug, the 2006 Plan B became available over the counter for users 18 and older. In 2009, the minimum age was dropped to 17. Those under 17 are still required to see a doctor to acquire the emergency contraceptive.

In February, in an attempt to stay on the cutting edge, Teva submitted an application to the FDA to change the pill's dual-label status (which makes it an over-the counter for adults and prescription-based for minors) and has fought regulators tooth-and-nail ever since.

In its statement Wednesday, HHS Secretary Kathleen Sebelius said the decision "reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional."

For Teva, a positive decision was long-awaited and could not have arrived at a more timely moment, making today's disappointment all the more crushing for the company. Teva shares have been lagging peers and are down more than 23% on the year. Generic versions of its other drugs have pressured its bottom line, and the company has been looking at outsourcing operations to save on margins.

Had Plan B become a shelf item like any other over-the-counter drug, it would have created a bounty for Teva's revenue. Bloomberg reports that in 2006, sales more than doubled when the pill became available over-the-counter for users 18 and up. Teva would likely see similar increases had minors been granted access the drug, no matter how much a portion of the public opinion winces at the possibility.

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