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 The outdated regulations that drive to mandatory animal testing should be ended.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 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.

Latest Emergent News

Today Janet Woodcock issued a statement “FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines” which links to the April 2021 Form 483 of the Baltimore facility.

  • Failures to investigate deviations
  • Failures for material management
  • Failures for gowning
  • Failures of the cleaning program
  • Failures in facility design
  • All around failure for contamination control
  • Failure to have a comprehensive training program

I have requested hearings from my congressional representatives. The path where Emergent received so much money from the federal government to lead to this place is frightening.