U.S. Judge lashes out at FDA over its Plan B maneuver

Teva Pharmaceutical Industries' ($TEVA) hot potato contraceptive drug Plan B One Step is getting tossed around some more, as a U.S. federal judge labeled the U.S government's position on it "intellectually dishonest."

According to The Wall Street Journal, U.S. District Judge Edward Korman said making girls 15 and older show an age ID is especially hard on the low-income and questioned how the government could argue against IDs as a barrier to voting but then support them for getting the drug. Korman last month ordered the FDA to remove the age and ID restrictions within 30 days and allow the contraceptive to be sold in stores off the shelf. Reuters reports the judge by Friday will decide whether to give the government more time to appeal his original ruling.

Korman's remarks Tuesday were directed at a new stance the FDA has taken on the drug. The FDA had restricted the so-called "morning after" pill to girls and women 17 and older who could prove their age. But after the judge ordered all restrictions be removed, the FDA approved the drug for girls 15 and older with proof of age. It also ordered Plan B removed from behind pharmacy counters. The FDA said it was approving a later application that Teva filed after more stringent restrictions were put in place in 2011 in a controversial ruling by Health and Human Services Secretary Kathleen Sebelius.

Plan B can prevent pregnancy if it is taken within three days after a sexual encounter. In 2011, the FDA actually decided it was time for the birth control pill to be available to prevent unwanted pregnancies and made the controversial decision to allow girls as young as 11 to get it. Sebelius overruled the agency in a move that was seen as caving in to political pressures.

Teva has remained out of the spotlight during the fight. "I'm not interested in getting into politics," Teva CEO Jeremy Levin said at a Reuters-sponsored health conference when asked about the legal tug-of-war. "The bottom line is that we believe we are providing an important medicine."

- read the Reuters story
- here's more from The Wall Street Journal (sub. req.)

Related Articles:
Judge gives FDA 30 days to make Teva's Plan B available to adolescents OTC
FDA rules on Plan B, but not on judge's order
FDA battling White House over politicization of regulation
HHS chief smacks down FDA's Plan B decision

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