Judge Slams FDA’s ‘Sweetheart Arrangement’ With Big Pharma That Limits Access To Morning After Pill

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"Judge Slams FDA’s ‘Sweetheart Arrangement’ With Big Pharma That Limits Access To Morning After Pill"

In a fiery decision on Friday, U.S. District Judge Edward Korman denied the Obama administration’s motion to delay an order to immediately allow over-the-counter access to emergency contraception to women of all ages. After Korman initially ordered in April that the so-called “morning-after pill” be available to all women and girls without a prescription, the FDA instead decided to lower the age limit to teens 15 and up rather than 17. However, those 15- and 16-year-olds will only have over-the-counter access to one brand of emergency contraception pill, Teva Pharmaceutical’s Plan B One-Step, thanks to what Korman called a “sweetheart arrangement” between the FDA and Teva.

Blasting the Obama administration’s argument as “an insult to the intelligence of women,” Korman attacked the FDA’s decision to lower the age restriction for Plan B rather than comply with his order to allow all women access to any brand of emergency contraception. The judge accused the administration of delaying his ruling so as to give Teva Pharmaceutical sole access to the market of 15- to 17-year olds without a prescription. Generic versions of Plan B, meanwhile, will stay behind the pharmacy counter for this age group.

Korman also noted that Teva will drive up the price of the pill now that it has a monopoly on young women in need:

While this proposal was a boon to Teva, it did little to eliminate the practical obstructions in obtaining emergency contraception to women of child-bearing age whether over or under age 15. On the contrary, Teva will use its privileged marketing status and exclusivity to increase the cost of the drug. The price of Plan B One-Step under the new marketing regime is expected to be $60, significantly more than the one- or two-pill generic version, and could conceivably go higher, if only to accommodate the more expensive packing, age-verification tags, and anti-theft technology that the new marketing arrangement would require.

As Teva profits from the Obama administration’s arbitrary age restriction, the burden on women seeking emergency contraception will only grow larger. Younger teens and undocumented women unable to prove their age with government-issued ID will still not have access, and may not be able to afford the new cost. As Korman points out, the Teva-FDA deal still requires Plan B to be sold over the counter at stores with on-site pharmacies, even though many women do not live near such facilities. The decision also cites a survey of 943 pharmacies in 5 cities, which found that only 4.7 percent stayed open 24 hours. Given the time-sensitive and often urgent need for emergency contraception, limiting the hours and locations where women can buy the drug could have serious consequences.

Moreover, there is no medical reason to limit access to the morning-after pill. Despite the Obama administration’s concern that it could be “dangerous” to young teens, an enormous body of research has demonstrated emergency contraception is safer than aspirin for women of all ages.

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