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.

PIC/S Guidance on Data Integrity is final

This week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) finally announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors has come into effect.
 
This final version is of a draft document originally introduced in 2016 and re-issued as a draft in 2018. It’s been a long road to get final version. Final version here.

Critical ATMP Deficiencies

ERC The Netherlands B.V. received thirteen deficiencies from a recent inspection, one of which was classified as a critical deficiency.


These were mainly related to five main components:

  • Quality and safety of starting materials. Inspection of chemicals and consumables is insufficient.
  • The quality and safety of the final product is not guaranteed. The product is not sufficiently defined and characterized.
  • The effectiveness of a gama irradiation step, and therefore the safety of the product, is not guaranteed.
  • The change for the transition from Contractor 1 to Contractor 2 for gamma irradiation of cells has not been carried out as referred to in the GMP for ATMPs.
  • Prevention of (cross) contamination is not sufficiently guaranteed. 
  • The environmental monitoring program and personnel monitoring are inadequate.

Reviewing this together with Emergent’s 483 (and resulting actions) starts to define a set of concerns in the ATMP world.

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.