A U.S. court dismissed on Tuesday a lawsuit against U.S. health regulators over their decision to allow the sale of Barr Pharmaceuticals Inc Plan B contraceptive without a prescription.
The U.S. Food and Drug Administration and Barr were sued by the Association of American Physicians and Surgeons and other groups that sought to overturn the FDA’s decision.
The U.S. District Court for the District of Columbia granted FDA’s and Barr’s motion to dismiss the suit.
The court said it agreed with defendants that plaintiffs failed had “to identify a single individual who has been harmed by Plan B’s OTC (over-the-counter) availability,” according to the ruling.
Plan B was approved in 1999 and the FDA broadened the approval in 2006 to allow sale to adults without a prescription. The pills must be kept behind pharmacy counters and only sold to girls younger than 18 years old with a doctor’s order.
Separately, on Monday, another U.S. court found the patent for Bayer AG’s Yasmin contraceptive drug to be invalid, paving the way for Barr to sell a generic version.
“It’s a big win for Barr,” Natixis Bleichroeder analyst Corey Davis said of the Bayer ruling. “This could be one of those nice generic products with a long tail on it,” he said.
Barr shares were up $4.23 or 9.3 percent to $49.90 in afternoon trade on the New York Stock Exchange.
Important Safety Information
Plan B® does not protect against HIV infection and other sexually transmitted infections (STIs). You should not take Plan B® if you are already pregnant (because it will not work).
Side effects with Plan B® include nausea, abdominal pain, fatigue, headache, menstrual changes, dizziness, breast tenderness, vomiting, and diarrhea. Menstrual bleeding may be heavier or lighter, earlier or later after taking Plan B®.
If your period is more than a week late, pregnancy should be considered. Do not take Plan B® if you are allergic to levonorgestrel or any of the ingredients in Plan B®. Plan B® should not be used as routine birth control.
You have a Second chance
Things do not always go as planned. You might have forgotten to take your pill, or another birth control method you used might have failed. Now you have a second chance to prevent pregnancy with Plan B®.
- Plan B® is an emergency contraceptive that can still prevent a pregnancy after contraceptive failure, unprotected sex, or sexual assault.
- Plan B® should be taken within 3 days (72 hours) of unprotected sex and can reduce the risk of pregnancy by up to 89%. But the sooner you take it the more effective it will be.
- Plan B® is not RU-486 (the abortion pill); it will not work if you are already pregnant.
Plan B® is not a substitute for routine birth control. It’s important to remember that Plan B® does not protect you from HIV infection (the virus that causes AIDS) or any other sexually transmitted disease (STD).
Plan B pills contain higher doses of progestin, a hormone used in prescription birth control pills for 35 years. Two pills cut the odds of pregnancy by nearly 90 percent when taken within 3 days of sexual intercourse.
The Plan B lawsuit claimed the drug was not proven safe without a prescription and sought to reverse the decision and require a prescription for all Plan B sales.
FDA spokeswoman Rita Chapelle said the agency was pleased with the ruling. Barr spokeswoman Carol Cox, who called the lawsuit “meritless,” said her company was also pleased.
Anti-abortion groups including the Family Research Council and Concerned Women for America had joined the doctors’ group in trying to reverse the FDA decision.
The groups failed to prove their standing to sue, the court said. In its conclusion it said that “plaintiffs have failed to exhaust their administrative remedies and have therefore failed to state a claim upon which relief can be granted.”
The abortion rights group Center for Reproductive Rights is suing the FDA for the opposite course of action. In its lawsuit against the agency, it argues that restricting the drug for girls under 18 was based on politics and not science.
It is waiting for a judge in New York to rule on its summary judgment motion.
Barr shares were up 8.2 percent to $49.42 in late Tuesday morning trade on the New York Stock Exchange. On Monday, another U.S. court found the patent for Bayer AG’s Yasmin contraceptive drug to be invalid, paving the way for Barr to sell a generic version.
By Kim Dixon