Making Drug Manufacturing Great Again

by is licensed under
President Trump wants to lower drug prices and reinvigorate domestic pharmaceutical manufacturing. 

Bravo. But standing in the way is the inside-the-Beltway gospel that preaches that regulators love ambiguity.

As a former FDA associate commissioner, I can affirm that's true. Vagueness gives the agency almost unlimited authority to do whatever it wants.

But, when it comes to the FDA, it's predictability in pursuit of the public health that's important. And nowhere is this truer or more timely than when it comes to the oversight of drug manufacturing.

Drug manufacturing isn't sexy to the general public and rarely makes headlines — unless something goes wrong. Recalls make headlines. Adherence to current good manufacturing practices (GMPs) do not.

A few years ago I had the chance to visit Pfizer's Kalamazoo production facility. What impressed me more than the gee-whiz production aspects of the facility (of which there were plenty) was the dedication of the people who work there — top to bottom.

It actually reminded me a lot of the FDA. Long-term employees dedicated to serving the public health through dedication to quality. And they all took it very personally. Just like at the FDA, the Pfizer folks were on personal missions of quality. There was a lot of pride on display.

Mr. President — there hasn't been an exodus of pharma manufacturing to foreign shores. In fact, when I visited the Kalamazoo facility they were exporting (among other things) the active pharmaceutical ingredient (or API, the actual drug substance) for methyl prednisolone (a corticosteroid long off patent) to both China and India.

 
Article Photo Credit: by is licensed under
Sign Up for Our Email Newsletter

RECENT NEWS

Drug shortages reaching record levels
  • Scripps News
  • 09/19/2023 12:00 AM

Drug shortages reaching record levels

Drug Shortages reaching record levels in the United States in nearly a decade...  Read more

Sorry, but the ‘drugs from Canada’ don’t work

Sorry, but the ‘drugs from Canada’ don’t work

“Drugs from Canada” is a policy that won’t work. And a political soundbite that won’t die....  Read more

When It Comes to FDA Communications

When It Comes to FDA Communications

Perhaps the most important lesson learned from the COVID-19 experience is that American health illiteracy kills....  Read more

DRUGWONKS BLOG