What your stuffy nose has to do with abortions

Accountability is long overdue at the FDA

If you’re one of countless Americans who suffered from a cold/flu/allergies this season, you may have reached for a popular over-the-counter decongestant. But just last week, an FDA advisory panel concluded that phenylephrine – an ingredient in more than 260 medicines that generates billions of dollars in sales each year – is (and has been for decades) completely ineffective:

The unanimous vote, which specifically declared oral formulations of phenylephrine ineffective, is expected to disrupt the market for OTC cold and allergy remedies, where consumers largely prefer pills over nasal sprays.

So, what in the world does this have to do with abortion?

Alliance for Hippocratic Medicine v. FDA: Doctors versus abortion pills

Last month, a federal appeals court found that the FDA likely violated the law when it weakened safety standards on the abortion pill (mifepristone), but the Court stopped short of ruling that it should not have been approved in the first place. Judge James Ho, in a scathing partial dissent, disagreed on that latter point.

Abortion advocates argue it would be “unprecedented” to remove an FDA-approved drug from the market after more than 20 years and that this would constitute a major disruption that would chill innovation and the FDA’s ability to do its job.

But as Tuesday’s vote suggests, the FDA may already be poised to revoke its “safe and effective” designation for a relatively benign medication that’s been used even longer and more widely.

The Wall Street Journal explains:

Phenylephrine, first permitted for use in 1938, didn’t go through the rigorous clinical trials that regulators require today for medications, and more recent studies found the ingredient to be ineffective at relieving congestion. The latest research prompted pharmacists and physicians to call for ending the sales of the drugs.

The drug appeared in OTC products at least as early as the 1950s and was FDA approved in 1976. It grew in popularity in the 2000s after drugs like Sudafed were moved behind the counter over concerns about abuse.

Pregnancy, a “life-threatening illness”?

When mifepristone was approved in 2000, the FDA ludicrously classified pregnancy as a “life-threatening illness” so they could fast-track the process. They also failed to perform required studies in the pediatric population – that is, adolescent girls. As a result, no one knows if or how the drug might affect their developing young bodies differently.

Many studies purporting to prove the abortion pill is safe are rife with financial conflicts of interest. Newer research using comprehensive Medicaid claims data shows that the rate of abortion pill-related emergency room visits increased more than 500% over a decade and a half.

Citizen petition: First line of recourse

In 2015, a group of researchers filed a citizen petition to get phenylephrine’s approval reversed. A citizen petition is a process in federal law that allows organizations or individuals (often drug companies, but not always) to ask the FDA to change a policy at any time.

Sound familiar? Concerned doctors have filed multiple citizen petitions over the years urging the FDA to restore safeguards on mifepristone. After those efforts were rejected, then they sought redress in the courts.

New studies debunk outdated talking points

“In conclusion, we do believe that the original studies were methodologically unsound and do not match today’s standard. By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant,” said Dr. Peter Starke, an FDA official who led the review of phenylephrine.

Instead of rebutting the findings with new evidence, a trade group representing the drug manufacturers argued that its removal would be a burden on consumers who prefer it and that alternatives would not be easy to come by. (Doctors on the panel disputed that.) According to one of their executives, “The bottom line is that oral phenylephrine is safe and that it works.”

This, too, sounds familiar. It is essentially the same argument made by the abortion lobby that mail-order abortion pills without in-person doctor supervision are more private and convenient – only this time it’s the FDA and Biden administration lawyers standing beside them repeating the same tired talking point that mifepristone is “safe and effective.”

“Do no harm”?

NBC notes that ineffective doesn’t necessarily mean harmless; phenylephrine can cause unpleasant side effects or raise blood pressure at high doses. Still, that’s a far cry from arguing it has killed patients or landed them in the emergency room. Even the FDA’s own data, inadequate as it is, shows deaths associated with mifepristone. Yet in a stunning example of circular logic, the FDA quit tracking complications other than death – then used the lack of reports to justify rolling back safeguards.

When Americans are aware of these facts, they overwhelmingly agree that the abortion pill wasn’t adequately vetted, and they find it harder to trust the FDA. Like cold medicine that’s a dud, this is another case where doctors and many average laypeople are already far ahead of official accountability.

Time will tell whether politics trumps health and science or whether Americans can expect governmental agencies to be accountable and not act above the rules.