Tag Archives: regulation

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.

Holding Some Back

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Forty-three million students are doing homework at home due to the current Wuhan virus situation.

Here’s the shocker about that:

Some public schools are calling online work “enrichment,” not part of the curriculum, because they can’t guarantee that all students will have access to it.

The work, which was part of the curriculum when school was in session, won’t be graded, won’t count.  This is another example of the Left’s view of equality: hold back the successful because the less successful don’t, or can’t, keep up.  Don’t take steps to help the less successful do better. No, that’s too hard.

Remember this view of equality next November.

Scapegoating

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…and fake apologies.

Recall that Doctor Li Wenliang, a resident of Wuhan, Hubei Province, People’s Republic of China and an ophthalmologist at Wuhan Central Hospital, gave early warnings about the dangers and contagious nature of the Wuhan virus. Recall further that subsequent to his warnings, the police were sicced on him and that they threatened him if he didn’t shut the hell up. Li subsequently died of that same Wuhan virus.

Now the Communist Party of China is pretending to apologize to his family for that behavior.

The party’s top disciplinary body said the police force in Wuhan had revoked its admonishment of Dr Li Wenliang that had included a threat of arrest.
It also said a “solemn apology” had been issued to Li’s family and that two police officers, identified only by their surnames, had been issued “disciplinary punishments” for the original handling of the matter.

Punishing two cops who were caught up in the early stages of the CPC’s attacks: nothing like a couple of scapegoats to put an end to the escapade.

Sure.

A Start

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But we need to go further.  Recall that an official of the Communist Party of China threatened to cut off US access to life-savings medicines that are manufactured in the People’s Republic of China [Bing Translate translation from the Xinhua publication].

If China retaliates against the United States at this time, in addition to announcing the travel ban on the United States, it also announced the strategic control of medical products and the ban on exports to the United States, then the United States will fall into the ocean of new crown [corona] viruses.

Senator Tom Cotton (R, AR) and Congressman Mike Gallagher (R, WI) have introduced legislation that will begin to address such dependencies and improve our national security.

The Chinese Communist Party threatened to cut off America’s access to vital drugs in the midst of a pandemic caused by its own failures. It’s time to pull America’s supply chains for life-saving medicine out of China and make the CCP pay for contributing to this global emergency.

The proposed legislation would

  • task an FDA registry with tracking drug ingredients
  • ban the Federal government from buying drugs with a supply chain that originates in the PRC
  • require drugs to be labeled with the name of the country where they came from
  • provide benefits to manufacturers who make their drugs or medical equipment in the US
  • take effect in 2022.

But it, or quickly following legislation, needs to go much farther.

  • Feds should buy no drugs with a supply chain that passes through the PRC, not merely originate there
  • manufacturer benefits should be limited to preferential government buys and support for drug development, not overt outlays of taxpayer money
  • push the pace: the requirements should take effect in 2021, or sooner, depending on how quickly manufacturers can readjust their supply chains

Further legislation should do the same regarding other items important to national security, items like medical equipment, computer chips of all types, energy-related equipment.

“Novel Ways to Apply Homicide Liability”

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That’s what an ex-federal prosecutor in DC and current “legal” analyst for a broadcast network’s cable outlet says he was always on the lookout for in those unfortunate days of his prosecutor-ness.

Rule by law, instead of rule of law—this ex-federal prosecutor is an example of that.

Show me the man, and I’ll find you the crime—this ex-federal prosecutor is the modern example of Lavrentiy Beria.

We have ‘way too many Federal criminal laws, laws, too, that usurp the individual States’ legitimate police powers—this ex-federal prosecutor demonstrates the failure of that and illustrates the need to “quinquagintate” those Federal criminal laws and then target pare from there..