Tag: Scott Gottlieb

Are New Federal Vaccine Laws Coming?

Have you seen the headlines?

CNN ran a story about how the Federal government might step in to change lax vaccine laws.

I wouldn’t be surprised if you haven’t, as few media outlets took the click bait and ran with the story…

Are New Federal Vaccine Laws Coming?

So what’s the story?

FDA Commissioner Dr. Scott Gottlieb originally told Axios that “Too many states have lax laws.”

This led to the article by CNN.

“Some states are engaging in such wide exemptions that they’re creating the opportunity for outbreaks on a scale that is going to have national implications,” FDA Commissioner Dr. Scott Gottlieb said Tuesday in an interview with CNN.

If “certain states continue down the path that they’re on, I think they’re going to force the hand of the federal health agencies,” he added.

FDA chief: Federal government might step in if states don’t change lax vaccine laws

Force the hand of the federal health agencies to do what?

“The commissioner was vague on when he thought the federal government should take action and what exactly that action should be. “You could mandate certain rules about what is and isn’t permissible when it comes to allowing people to have exemptions,” he said.”

FDA chief: Federal government might step in if states don’t change lax vaccine laws

Yeah, except neither the FDA, CDC, nor any other federal health agency could actually do that.

“Historically, the preservation of the public health has been the primary responsibility of state and local governments, and the authority to enact laws relevant to the protection of the public health derives from the state’s general police powers. With regard to communicable disease outbreaks, these powers may include the enactment of mandatory vaccination laws.”

Mandatory Vaccinations: Precedent and Current Laws

Of course, that hasn’t kept anti-vaccine folks from getting their feathers ruffled.

Is a story about something that can't really happen a coordinated attack on our medical freedom?

What could the Federal government do about vaccines to cause folks to revolt?

“Any federal mandatory vaccination program applicable to the general public would likely be limited to areas of existing federal jurisdiction, i.e., interstate and foreign commerce, similar to the federal quarantine authority. This limitation on federal jurisdiction acknowledges that states have the primary responsibility for protecting the public health, but that under certain circumstances, federal intervention may be necessary.”

Mandatory Vaccinations: Precedent and Current Laws

Not much.

There isn’t much room for the Federal government to intervene to improve vaccination rates at the state level, except maybe to make sure that vaccines are readily available to everyone that wants them.

Federal jurisdiction over public health matters derives from the Commerce Clause, which states that Congress shall have the power “[t]o regulate Commerce with foreign Nations, and among the several States….”

Mandatory Vaccinations: Precedent and Current Laws

Or is there…

Vaccine preventable diseases are just a plane ride away.
Vaccine preventable diseases are just a plane ride away.

Considering that most measles outbreaks are imported, one very simple Federal law that could help might be one that simply reminds folks who plan a trip out of the country to get vaccinated and protected.

That could help them remember to get caught up on their vaccines so that they don’t come home measles, triggering an outbreak.

Not a requirement to get vaccinated, as that would be hard to enforce, but education and reminders about the recommended vaccines you should get before a trip.

Would that cause anti-vaccine folks to revolt?

Are New Federal Vaccine Laws Coming?

Vaccines and the Government Shutdown

Think that everything related to vaccines and vaccine-preventable diseases are exempted during a government shutdown?

“A shutdown furlough (also called an emergency furlough) occurs when there is a lapse in appropriations, and can occur at the beginning of a fiscal year, if no funds have been appropriated for that year, or upon expiration of a continuing resolution, if a new continuing resolution or appropriations law is not passed. In a shutdown furlough, an affected agency would have to shut down any activities funded by annual appropriations that are not excepted by law. Typically, an agency will have very little to no lead time to plan and implement a shutdown furlough.”

Pay & Leave Forlough Guideance

Nearly half of government employees have been furloughed without pay since the beginning of the most recent government shutdown, while some others are working without pay.

Vaccines and the Government Shutdown

Among those government employees who have been furloughed include nearly 40% of the staff at U.S. Department of Health and Human Services (HHS).

It would have been much more if much of HHS’s operating divisions, representing about 60% of HHS staff, had not already been funded through September 2019. So the CDC and NIH should be working as usual.

Some HHS divisions that are funded through Agriculture and Interior appropriations were hit by the shutdown though, including the EPA, FDA, and Indian Health Service.

The FDA works to regulate and approve vaccines. Will that work be affected by the shutdown?

Some of the work at the FDA is done via user fees instead of government funding, but that money is running out and they can't accept new user fees!
Some of the work at the FDA is done via user fees instead of government funding, but that money is running out and they can’t accept new user fees!

Maybe…

Most other vaccine programs likely won’t be affected though.

  • Center for Biologics Evaluation and Research (CBER) – regulates vaccine products and is financed by user fees, so doesn’t depend on government funding. Except that they can’t accept new user fees!
  • Vaccines For Children Program – already funded through the Centers for Medicare & Medicaid Services (CMS) to the Centers for Disease Control and Prevention
  • National Vaccine Injury Compensation Program – funded by an excise tax on vaccines
  • VAERS – co-administered by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), it is still up and running…
  • National Vaccine Program Office – funded through HHS
  • National Science Foundation – closed and no new funding opportunities will be issued and no payments will be made.
  • National Institutes of Health – funded

We are already hearing stories about what is happening as the Indian Health Service goes unfunded.

What happens if CBER runs out of money? Unfortunately, we may soon find out.

More on Vaccines and the Government Shutdown