From APC’s CEO

Here’s opportunity knocking

R. Scott Brunner, CAE
APC Chief Executive Officer

APC President Michael Blaire is away celebrating his daughter’s wedding (Mazel tov!) so this week’s column is from our CEO Scott Brunner....

Timing is everything, as they say. Right now, the timing is perfect for you to help drive home to policymakers the seriousness of the threat to compounded hormones.

Here’s what’s up:

Over the past six weeks or so, our cBHT media campaign has begun to get traction on Capitol Hill. Through the (slightly creepy) wonder of modern technology, I can tell you that over the past month, our campaign landing page at compounding.com has been accessed more than 200 times by more than 65 congressional offices. On top of that, our lobbying team has been socializing the issue with individual members of Congress, meeting with their staffers and sharing our briefing documents.

That alone is good news. But here’s the opportunity to capitalize on that good news:

Congress’s summer recess begins July 31. That means that for most of the month of August they’ll be back home, in district, and looking to interact with their constituents.

There’s no better time for you to schedule a pharmacy visit with your U.S. representative or senator. Next to Compounders on Capitol Hill, there’s no better opportunity for you to share one-on-one with your elected officials your concern about the threat to compounded hormones. (You can also tell them about the good our urgent-use legislation, HR 3662, will do in shoring up gaps in the drug supply chain).

It all starts with a phone call to your MOC’s office to make the invitation. Download our simple guide for scheduling and conducting the visit, and once it’s scheduled, contact us here at APC and we’ll share the latest talking points and background so you’ll be completely up-to-speed for the visit.

Please seize this opportunity to show your member of Congress what you do and talk with them about the challenges your compounding patients and practice are facing.

Your timing will be impeccable.

Best,
Scott

Thoughts? Concerns? You can reach Scott Brunner at scott@a4pc.org.

A tremendous gift

Lucy Malmberg, compounding hero and co-founder of Wedgewood Pharmacy, has contributed $225,000 to APC’s cBHT media campaign. Thanks to her generous gift, we’re now within a hair’s breath of our $1.5 million goal!

The campaign has already been running online ads targeting members of Congress and their staff as well as FDA staff, directing them to Compounding.com where they can learn the truth about cBHT and the people who rely on it ... in those patients’ own words.

We’ve also increased our podcasting agenda, with our spokespeople having already been guests on 14 shows, with 11 more appearances scheduled for the next few weeks. In the works are print ads, more podcasts, and outreach through social media influencers ... but it all depends on having the funds.

Lucy’s generosity is a huge boost to the campaign. Now we’re about $45,000 short of our goal. Help us cross that finish line — contribute to save cBHT directly, and don’t forget: If you’re shopping at Letco Medical, contribute to the cBHT media campaign when you checkout — it’s just one extra click:

Making the case on HCG to FDA

On Tuesday, representatives of APC and the Outsourcing Facilities Association participated in a listening session with FDA staff about patient access issues created by the 2020 reclassification of certain substances as biologics — particularly HCG.

OFA director Lee Rosebush led the presentation, asking FDA to immediately clarify that “Deemed BLAs” may continue to be compounded pursuant to Section 503A and Section 503B of the Food, Drug & Cosmetic Act, and that FDA’s March 23, 2020, Notice to Compounders does not apply to pharmacies compounding transitioned products like HCG, which has a USP monograph.

APC members Tenille Davis of Civic Center Pharmacy in Scottsdale, Ariz., and Kim Keiffer of Empower Pharmacy in Houston, shared input with FDA on drug shortage and patient access issues the reclassification has created.

“Compounders have been compounding some of these drugs for nearly 50 years,” Rosebush said. “As of March 23, 2020, nothing in these drugs changed. HCG is the same drug that it was in 1973 when it was approved by the FDA. Patients should not suffer due to access issues resulting from an administrative conversion from an NDA to BLA.”

While FDA officials did ask questions in the listening session, they offered no comments or opinion on the presentation. “There’s no requirement that they respond or act on our request at all,” said APC CEO Scott Brunner, CAE. “So, as usual, it’s ‘wait and see’.”

View the APC/OFA July 20 Listening Session presentation slides here.

Two days and a night that can save your practice

It’s APC’s Compounders on Capitol Hill, and it’s your once-a-year chance to meet federal lawmakers on their turf, in person, and make the case for pharmacy compounding.

We’ve streamlined the even this year: Arrive in DC by noon on November 2 and be back to the airport by 5:00 pm on November 3.

In between you’ll be briefed on the issues, enjoy a Tuesday-night networking event*, and head for Capitol Hill Wednesday morning — we’ll have scheduled all the Hill meetings ahead of time.

You’ll get to explain face-to-face the challenges facing your compounding practice — and your patients:

• The MOU in interstate shipments.
• The threat to cBHT.
• Restrictions on dietary supplement compounding.
• The assault on pure-ingredient veterinary compounding. And more.

Plus you’ll get a chance to network with colleagues from across the country, visit with exhibitors, and earn 3 hours of CE credit. We’ve even got a "Moonlight & Monuments" tour of the capitol* — a fundraiser for the Pharmacy Compoudning Foundation.

Don’t miss this opportunity to remind the people in Washington not only how important pharmacy compounding is for patients, but how important it is for their constituents — you!

*optional ticketed event

Scott visits Leesburg and the Compounding Center

Here’s our CEO Scott Brunner on Tuesday with some of the team members at the Compounding Center in Leesburg, Virginia. Owner (and APC member!) Cheri Garvin, to Scott’s left, hosted him this morning for a tour … and good conversation.