FDA

Memo to Health Insurers: Pay Attention to Us

Memo to Health Insurers: Pay Attention to UThe text came from our 20 year old. His girlfriend had gone to her doctor to get the implantable birth control, Nexplanon, which (as every parent of a teenager might be happy to know) is nearly foolproof for 3 years. Needless to say, we were thrilled.

The problem?

It cost $1,500 and insurance wasn’t paying.

The Explanation of Benefits that Was Anything But

Impossible, I said (after all, there’s not much I know about but health insurance and the Affordable Care Act [ACA] are two). The ACA requires that most health insurers/employers provide all FDA-approved contraception with no out-of-pocket cost.

It took several back and forths between the girlfriend, her father, and me, including copies of the statement from the insurance company, before I figured it out. She was only seeing the insurance company statement, called an explanation of benefits (EOB), showing what was billed and what was paid. She didn’t owe a thing.

And therein likes one of the many problems with health insurance today. It’s unnecessarily complicated and confusing. After all, how many mere mortals … Continue Reading

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Plan B: Another Double Standard

For what appears to be the first time in history, the head of the Health and Human Services Department has overturned a decision by the FDA. Was this regarding a drug that was so potentially dangerous it could kill or permanently maim people? A drug for which we have little clinical trial evidence or history? A drug that is produced in appallingly unsafe conditions?

No. It is a drug–actually, a single pill–for which we have years of safety and efficacy data, that is exceedingly safe and easy to use, and, get this — doesn’t even require a prescription from a doctor–if you’re 17 and older.

What it does is require is that the patients buying it be at least 17 years of age and head to the back of drugstores to give their names and identification to a pharmacist before receiving it. Oh, and if the pharmacist doesn’t want to provide it, he/she doesn’t have to. And it does require a prescription for those 16 and younger.

It’s Plan B, aka “emergency contraception.” All its manufacturer was asking was that we stop requiring that women who need it — those who had unprotected sex, missed a couple of birth control … Continue Reading

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Quote of the Day

“With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug. . . We can’t allow this government takeover of health care to continue any longer.”

That quote, courtesy of this morning’s Washington Post, incensed me to such a degree that I am writing this blog despite the two deadlines I have today. The speaker is Sen. David Vitter (R-La). The “disappointing decision” he refers to: The FDA’s decision to remove the breast cancer indication for Avastin (bevacizumab).

I wrote about this earlier, and you can read the post here, but that was before yesterday’s decision. I’m not going to comment here on the benefits or risks of Avastin. . . except to say that I’m sure there are individual women who are alive today because of it, and, quite possibly, individual women who are dead today despite it. But that’s not how we do medical science, based on individual patients. We do medical science based on large clinical studies (which are often designed with and approved by FDA officials). It’s not a perfect system, but it’s the system we have.

For more than 50 years, that system … Continue Reading

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