Expert panel unanimously backs new 'morning after' pill

In an 11 to 0 vote, an expert FDA panel voted in favor of approving Ella, a 'morning after' pill made by French drugmaker HRA Pharma. The drug has become a lightning rod for controversy, with anti-abortion advocates claiming that it's similar to the abortion pill RU-486. HRA, however, says Ella prevents pregnancy by blocking the effects of the hormone progesterone and delaying ovulation.

Unlike the existing Plan B pill, which can be taken up to three days after intercourse but is less effective the longer a woman waits, Ella is just as effective on the fifth day as on the first. It's still not clear exactly how the pill prevents pregnancy. But committee member Dr. Scott Emerson noted that if a drug can prevent pregnancy up to five days after intercourse, it likely does more than just prevent ovulation.

The panel found the drug to be safe and effective, though it did note that Ella is less effective in obese women. The experts voted 6 to 5 against requiring specific labeling to address that issue. Experts did strongly recommend that women do a pregnancy test before taking the drug, and said HRA should conduct a post-approval study of women who take the pill. If approved, Ella will be available by prescription only.

- read the New York Times article
- here's a WebMD piece for more

Suggested Articles

Xcovery's ALK inhibitor shrank tumors in 75% of lung cancer patients, compared to 67% for Pfizer's Xalkori, the first FDA-approved drug of that class.

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.