Daily Archives: 30 March 2020

In Defense of an Election Defeat

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Ex-Congressman Dan Lipinski (D, IL) lost his State’s primary election largely—almost entirely—because of his pro-life position on abortion.  He wrote an op-ed for The Wall Street Journal explaining how that loss came about:

I faced it [the question of whether he should have changed his abortion stance to win the primary] head-on in my statement. I defended my pro-life position, which is rooted in both my Catholic faith and science. “I could never give up protecting the most vulnerable human beings in the world, simply to win an election,” I said. “My faith teaches, and the Democratic Party preaches, that we should serve everyone, especially the most vulnerable. …”

Then he closed his piece with this:

[P]arty leaders and presidential candidates refuse to tolerate anyone who doesn’t support abortion on demand at any time, paid for by taxpayers.
The Democratic Party asserts that its highest priority right now is to defeat President Trump. The party’s treatment of pro-life voters belies that claim.

Party’s treatment of Party non-believers doesn’t belie the claim so much as it makes the claim harder to satisfy. After all, babies don’t vote, but pro-life citizens of all political bent do.

Kudos to this rare Democrat who put integrity and honor and respect for life above winning an election.

FDA’s Drug Approvals

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Charles Hooper and David Henderson are on the right track.

The Federal government requires pharmaceutical companies to prove that their drugs are both safe and effective before putting them on the market. Before 1962, companies needed to prove only safety. While there is some appeal to this two-hurdle approach, evidence suggests that there is only a slight benefit and a tremendous cost. With the COVID-19 pandemic sweeping the world, there has never been a better time to revoke the Food and Drug Administration’s efficacy requirement.

I suggest the FDA move to a two-stage approval process. The first stage should focus on safety: does the drug do no harm, at least compared with the condition it’s aimed at treating (because all drugs have side effects).  Once it’s determined the drug is safe, it should be released to the market, limited strictly to on-label use. Let prescribing doctors and patients determine whether the drug is useful, let market forces do their trick. The FDA’s imprimatur for this stage, should be limited to “safe as prescribed, not determined to be effective.”

The second stage should proceed without delay, overlapping the first stage to the extent feasible; in this stage, investigative focus should be on efficacy—does the drug actually have the effect on its target condition that’s intended. Only after the trials associated with this stage have been successfully completed could the drug receive its full-up FDA stamp of approval—and authorization for use, under prescription, off-label.

This modification to the pre-1962 requirement would cheapen development, and it would provide more drugs of greater utility faster to market and to the doctors and patients who use them.