From APC’s President

Hearing what we had to say

Michael Blaire, RPh, FIACP
APC President

A listening session is similar to a focus group — it’s a type of facilitated discussion with a group of people, aimed at collecting information about their experience.

Participants in a listening session are asked to talk about what they know and think, and sometimes to answer specific questions about a topic. Generally, the goal is to understand the opportunities and challenges surrounding a topic as stakeholders perceive them. The hosting agency or organization can then use the information participants share to determine what changes or actions are necessary.

In an environment where stakeholders often have limited means to give feedback, listening sessions are a tool to collect valuable information about people’s experiences.

The FDA holds frequent listening sessions on a number of issues in an attempt to gather information from stakeholder groups. This week, APC CEO Scott Brunner, APC’s Governmental Affairs Counsel David Pore, and I attended FDA’s Annual Listening Session on Compounding (with pharmacy, consumer, and industry stakeholders).

This annual meeting provides an open forum for stakeholders to share views and information with FDA regarding implementation of its statutory authorities on drug compounding. In addition to APC, there were representatives from ACHC, APhA, ASHP, NASPA, NCPA, and several other organizations with initials I don’t remember. There were also at least twelve members of FDA’s Office of Compounding Quality and Compliance.

Perhaps it was the virtual format, but this listening session felt different from past events, where FDA participants sat on one side of the room and stakeholders sat on the opposite side, with an imaginary wall between us. We spoke, FDA listened, and little dialogue followed.

This time I felt that the FDA members were as engaged as the stakeholders, asking pertinent follow up questions and providing informative —though non-committal — feedback.

Discussion topics included the need to delay implementation of the MOU, the beneficial effects of FDA’s temporary guidances due to Covid-19, the need for "urgent use" allowances for 503A compounders (HR 3662), adverse event reporting and communication with state boards of pharmacy, and finally, the need for FDA to close out Form 483s in a timelier manner.

The two-hour session passed quickly, and I believe that Scott, David, and I represented our membership well, frequently taking the lead on topics and garnering support from our sister associations. At its conclusion I felt the session was collaborative, and, although no one from FDA was committing to anything, I believe they not only listened, but they heard what we were saying. Ever the optimist, I await FDA’s actions to prove me right or wrong.

Michael Blaire is APC’s president, but his day job is vice president for government and regulatory affairs at Wedgewood Pharmacy in Scottsdale, Arizona. You can reach him at mblaire@wedgewoodpharmacy.com.

CCH moved to November 2–3

The dates for APC's 2021 Compounders on Capitol Hill have changed: The event will now take place in Washington, D.C., on Tuesday and Wednesday, November 2 and 3. Why? We want to be sure that, in the wake of the pandemic, congressional office buildings will have reopened to visitors.
We're making it quick and easy: Fly in Tuesday morning and fly out by 5:00 pm Wednesday — and in between help make the case for the importance of pharmacy compounding, as well as educate members of Congress on the critical issues the profession is facing. Details of the program will be coming soon. In the meantime, mark your calendars!

cBHT campaign: The last days are here

The fundraising window for APC's cBHT media campaign is almost closed, and we’re still about $375,000 short.

Put simply, if we're unable to raise the money we need in the next week, we won't be able to secure ad placements this year, and we'll lose the campaign momentum we're starting to build — Compounding.com is going strong, and we need to build on that. (And remember: We don't know when FDA might act to restrict compounded hormones. We cannot risk waiting — we need to be proactive, not reactive if we're going to protect cBHT.)

Remember: Through June 30, any contribution you make to the campaign will be doubled by Medisca — we're in reach of our $1.5 million goal! Click here or the image below to support the campaign!

Last Friday, APC held a town hall briefing that covered the state of the cBHT media campaign, the media we've produce so far, and some of the tools available for members. Click below to watch it.

Has your MOC signed the Cuellar/Dunn letter to FDA?

Reps. Henry Cuellar and Neal Dunn are asking fellow congressmen and -women to sign their letter to FDA requesting a delay in the MOU's implementation.

We need more representatives to add their names to that letter, and you can help. Please email, call, or visit your member of Congress and urge — strongly urge — them to sign that letter. They need to hurry – the letter is set to be mailed late next week!

HR3662: Getting the message out

APC told researchers at Mercatus about HR3662 — APC's urgent-use legislation — and how compounding came to the rescue when the pandemic started. The result is a terrific op-ed in The Hill: "How 'compounding pharmacies' can prevent the next drug crisis."

We still need cosponsors for HR3662! Click here to see if your representative is on the list. If not, reach out and ask them to co-sponsor the bill that will keep compounders as a critical safety net during drug shortages.

Scott goes visiting

APC's CEO Scott Brunner visited a couple of APC-member compounding pharmacies this week. He's with owner Renee McCarthy at her charming Cape Drugs in Cape St. Claire, Md. (left photo below).

He also visited Wedgewood Pharmacy in Swedesboro, N.J. (right photo below), for talks with (l. to r.) compliance director Anthony Grzib, CEO Marcy Bliss, and founder Lucy Malmberg.

Loyal APC members all!