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What did fmr. US surgeon general and WISH med. expert say about judges’ rulings on abortion pill

INDIANAPOLIS (WISH) — A big medical headline recently said a Texas judge has blocked the U.S. Food and Drug Administration’s approval the most commonly used abortion medication mifepristone.

Dr. Jerome Adams, the WISH-TV medical expert and a former U.S. surgeon general, visited News 8 on Tuesday to talk about the drug.

“That’s been used by over 1.5 million women in the United States since it gained FDA approval first in the year 2000. It’s used part of a two drug regimen, and it’s administered along with another drug called misoprostol. So, it’s confusing for folks. Misoprostol is also what people are not think of as Plan B, a birth control drug. It’s important to know these are not the same things. Plan B prevents pregnancy whereas the drug that the judge said the FDA should no longer be administering, mifepristone, actually stops a pregnancy.”

Adams talked about potential safety issues. “Do you believe it’s safe? Doc? “Over 100 studies over the past 25 years have been done on this medication. Now, scientists think that it’s safer than penicillin. So safe is relative, but there are many more drugs out there that the evidence suggests are more, far more dangerous than what this medication is.”

What does the court’s decision mean for the drug moving forward? Adams said that it’s completely in limbo because you had another ruling out in the state of Washington where they said the drug had to left available for the states where that judgment covered. And so states such as Massachusetts are holding onto the drug to make sure that have access for women. And it’s going to have to go to the Supreme Court before we find out.

“What we know is that at least in the meantime, it’s going to mean limited access to this medication for many people across the United States.”

Two decades ago, the FDA green-lit this drug under an accelerated approval. What does that process look like? And how often are drugs approved under the accelerated review?

“This is at the crux of this case. An assertion was made that this medication was unsafe because it had been approved under accelerated approval and accelerated approval started in 1992, in the wake of the HIV crisis in this country, allowing for timelier approval of drugs to treat serious conditions or that fill an unmet need.”

The accelerated approval been “successfully used to provide cancer medications, sickle cell medications and even Alzheimer’s treatments,” Adams said.

“So the the the real question here is why now, why this drug, why is it different? Many people feel like this is going to have a chilling effect on pharmaceutical manufacturing and their willingness to produce controversial drugs in the future no matter who needs them because of the fear that people may come along and actually sue the FDA to get them removed from the market.”

Health spotlight is presented by Community Health Network.