Monday, September 22, 2014
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Appeals court says two-dose, emergency contraceptive OK for all, but Teva's Plan B One-Step in limbo

Though the legal tussles will continue, a federal appeals court ruled Wednesday that the government can't restrict the sale of two-dose, over-the-counter, morning-after contraceptives to women below a certain age.

Appeals court says two-dose, emergency contraceptive OK for all, but Teva’s Plan B One-Step in limbo

Teva Women´s Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill." (AP Photo/Teva Women´s Health)
Teva Women's Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill." (AP Photo/Teva Women's Health) AP

 A federal appeals court ruled Wednesday that the government can't restrict the sale of two-dose, over-the-counter, morning-after contraceptives to women below a certain age.

The U.S. Court of Appeals for the Second Circuit, which covers New York, removed the stay of an earlier ruling that prevented the sale of the two-dose version.

The legal and regulatory fight about non-prescription access to emergency contraception has gone on for years. The key moment came in late 2011 when Health and Human Services Secretary Kathleen Sebelius overruled the Food and Drug Administration and restricted the sales to women 17 and older.

Teva Pharmaceutical Industries, Ltd., which has its Americas headquarters in North Wales, Montgomery County, got approval in April from the FDA to sell its Plan B One-Step, which is a single dose medication, to women age 15 and older. The FDA announcement on that is here. But the Teva Plan B One-Step won't be allowed to be sold at least until the Second Circuit judges hear the government's request to restrict access.

There are generic versions of the two-dose medications.

The early Associated Press story is here:

By Larry Neumeister and Lauran Neergaard

The Associated Press

NEW YORK — Generic versions of emergency contraception can be sold without a prescription or age restrictions while the federal government appeals a judge's ruling allowing the sales, a federal appeals court said Wednesday.

The brief order issued by the 2nd U.S. Circuit Court of Appeals in Manhattan permitted two-pill versions of emergency contraception to immediately be sold without restrictions, but the court refused to allow unrestricted sales of Plan B One-Step until it decides the merits of the government's appeal.

The ruling was welcomed by the Center for Reproductive Rights, where President Nancy Northup called it a "historic day for women's health."

"Finally, after more than a decade of politically motivated delays, women will no longer have to endure intrusive, onerous and medically unnecessary restrictions to get emergency contraception," she said in a statement.

Justice Department spokeswoman Allison Price said the government was reviewing the court's order.

The government has appealed U.S. District Judge Edward Korman's April 5 ruling, which ordered levonorgestrel-based emergency contraceptives be made available without a prescription, over-the-counter and without point-of-sale or age restrictions.

The government asked Korman to suspend the effect of his ruling until the appeals court decided the case, but the judge declined, saying the government's decision to restrict sales was "politically motivated, scientifically unjustified and contrary to agency precedent." He also said there was no basis to deny the request to make the drugs widely available.

The government had argued that "substantial market confusion" could result if Korman's ruling was enforced while appeals were pending, only to be later overturned.

The Food and Drug Administration was preparing in 2011 to allow over-the-counter sales of the morning-after pill with no agency limits when Health and Human Services Secretary Kathleen Sebelius overruled her own scientists in an unprecedented move.

The FDA announced in early May that the contraception could be sold without a prescription to those 15 and older. Sales had previously been limited to those who were at least 17. Korman later ridiculed the FDA changes, saying they established "nonsensical rules" that favored sales of the Plan B One-Step morning-after pill and were made "to sugarcoat" the government's appeal.

He also said they place a disproportionate burden on blacks and the poor by requiring a prescription for less expensive generic versions of the drug bought by those under age 17 and by requiring those over age 17 to show proof-of-age identification at a pharmacy.

David Sell
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David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

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