June 25, 2020

APC’s Advocacy Town Hall provides an important mid-year update

On June 24, Wednesday, APC held a virtual Advocacy Town Hall, where we updated members on the progress we’ve been making on our most important issues.

You can click here to listen to or download the audio of the call (MP3) or watch the video here.

Some of the issues brought up:

Animal health GFI: We reminded members that the comment period on the FDA’s draft GFI #256 has been extended to October 15, and that they should take advantage of that: submit comments and have patients (or their owners) explain how the current version could negatively affect their daily lives. In the meantime, Representative Ted Yoho, who is also a veterinarian, is taking the lead in drafting a letter from Congress to the FDA. (We’ll share the letter when it’s done, of course.)

We’ve made it easy; click here to submit a comment to the FDA on GFI #256.

FDA MOU on out-of-state shipments. While our arguments to the FDA itself may be falling on deaf ears, we do have an opportunity to push back on this poorly conceived MOU.

The FDA submitted a report to the Office of Management and Budget explaining the expected impact of the MOU. Luckily for us, it did an inadequate job of collecting information, and has severely underestimated the cost to state agencies. We think we now have a strong case that OMB should send the MOU back to FDA to have those deficiencies fixed — giving us more time to change the FDA’s definition of “distribution” to one that’s in line with the established meaning.

ESI/Tricare clawbacks. APC vice president David Miller also provided an update on the Tricare/ESI clawback issue that’s affecting hundreds of compounders across the country — you can read about that in item #1 of course.