The Cost of Generics

Production of generics has shifted overseas, where it’s harder for the Food and Drug Administration to inspect factories. Major companies have been caught faking and manipulating the data that is supposed to prove that drugs are effective and safe. Probable carcinogens have been discovered in the drug supply. During the pandemic, which caused several countries to ban the export of medical supplies, a new fear has arisen: that faraway factories might one day cut Americans off from their drugs. Dozens of lifesaving medications are made with ingredients no longer manufactured in the United States.

Stockman,FarahOur Drug Supply Is Sick. How Can We Fix It?” The New York Times, 18 September 2021

Philip Runyan pointed out this article today, and it is worth reading. It has personal connection with me, as well as professional in that my wife takes Levothyroxine. I’m a huge fan of Katherine Eban’s Bottle of Lies, and this opinion piece fits excellently into that strand of reporting. We need more reporters on this beat.

I do not think the quality of drug manufacturers worldwide are rising to the level of the US and Europe. I think onshoring is one of those trends that is going to shake the pharmaceutical world over the next decade. Civica is ahead of the curve, but not by much.

Good shoutout to Redica, one of my favorite tools for regulatory intelligence (but expensive).

Notice that Viatris (Mylan) fails at driving out fear. Layoffs are one of the largest possible sources of fear.

We will eventually see a quality rating system. Whether it looks like the FDA’s current metric initiative remains to be seen.

Time to Move Away from Animal Testing

Outspoken watchdog group White Coat Waste Project recently released an analysis of nearly 200 new drug applications submitted to the FDA between 2000 and 2020 to describe the impact of animal modeling.

There is litle reason for these tests, and frankly I think we’d all be thrilled to no longer need them. The outdated regulations that drive to mandatory animal testing should be ended.

In the report, the organization took special aim at the use of beagles. Around 11,000 puppies and dogs were used to satisfy the FDA’s testing requirement during that 20-year period. And my puppy definitely does not approve. Just thinking of all that wasteful testing puts him to sleep.

Lilly in the news

“rewrites factual data provided by subject matter experts to formulate responses she feels are more beneficial.”

Lilly hit by staff accusations, FDA scrutiny at COVID drug factories

Yesterday Reuters published a piece based on a purported recent internal complaint at Lilly on a Quality leader purportedly falsifying data.

This comes on top of a March report that “Insider alleges Eli Lilly blocked her efforts to sound alarms about U.S. drug factory.”

Lilly has had several decades of “promising to address GMP issues.” Are these signs of not addressing cultural issues? Of the balkanization of fixes? Of the infamous pendulum swing? I have no insight, but as an individual who was involved in the work of consent decree remediation at another company, I certainly have lots of questions about what is up at Lilly.

Emergent shakeups

Shakeups at Emergent

There is a lot to understand in this story. As congressional hearings unfold, and the shareholder lawsuit works the way through the courts, I hope we learn more about the how’s and the why’s.