This week Barr Laboratories' exclusive, competition-free period on Plan B expires, allowing cheaper generic drugs to take its place, but thanks to the maze of FDA regulations women may still not have increased access to emergency contraception.
Plan B has been approved for prescription use since 1999, but delays in over-the-counter approval and age restrictions left the emergency contraception in a gray limbo of regulation. One FDA official, Dr. Susan Wood, resigned after the FDA announced in 2005 that it would delay over-the-counter sales of the drug indefinitely. She called the motivation to stall the drug's over-the-counter sale "political."
Once the drug was finally approved, it could only be sold to women 18 and older. As a Newsweek article explains:
This put the drug into a very small category of medications with a two-tiered, age-based system. Others include Sudafed, which can be made into methamphetamine, and aids to quit smoking, like Nicorette, since it's illegal for those under 18 to buy nicotine products.
Because the drug was approved for OTC access in 2006, it "reset the clock" for Barr Laboratories' 3-year exclusive sale of the drug. Now, that exclusivity has expired. Still, the generic version, Watson Pharmaceuticals' Next Choice is usually only 10 percent cheaper. In the Newsweek article, they pointed out that a pharmacy might sell Plan B for $45 and Next Choice for $41. Barr Laboratories is also developing a version of Plan B that can be administered in one dose, unlike the current version, which requires users to take two pills.
With a combination of bureaucratic roadblocks and FDA regulators playing politics with access to reproductive choice, women are left with confusing and inconsistent access to emergency contraception. Not to mention that pro-choice advocates spend a lot of time debunking the myth that emergency contraception is the same as abortion. While the FDA and anti-choice groups argue about the way emergency contraception is dispensed, women may miss their opportunity to use it and end up facing a much bigger decision.