Here’s opportunity knocking

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.

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 recorded on 14 shows, with 11 more 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.

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.

Members of Congress request MOU extension

Sixteen members of the U.S. House of Representatives have sent a joint letter to Acting FDA Commissioner Janet Woodcock — a letter asking FDA to extend the deadline for signing the MOU with states on interstate shipments of compounded drugs.

The MOU is set to take effect October 27, and without an extension of that deadline, several states have indicated they cannot sign it. In states that don’t sign the MOU, federal law imposes on compounding pharmacies a five percent cap on out-of-state shipments — an outcome that could be catastrophic for patients who reply on compounded medications.

The letter from members of Congress follows similar requests of FDA from APC, APhA, NABP, NASPA, and NCPA.

We’re grateful to the following members of Congress for signing this week’s letter to FDA:

You can read the final, signed letter here.

cBHT campaign: THIS close to completion, but stalled

We’re so close, so close, we can taste victory.
But that’s just not close enough.

If cBHT is part of your compounding business and you haven’t yet contributed to help APC protect it — please, think like a business owner: Support the campaign to keep cBHT available for the millions of patients who need it.

Thanks to many of you — and our vendor partners — we’ve done great so far, with online ads and podcast appearances. We’ve got print and television marketing ready to go: a nationwide message that Congress and the FDA won’t be able to ignore … but only if we have the funds to get it out.

We’re this close. Help us hit that goal so we can protect cBHT, your patients, and your business.

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:

Don’t you hate being ALMOST good enough? (Us too.)

We’re so close, so close, we can taste victory.
But that’s just not close enough.

Look, if cBHT is part of your compounding business — and you haven’t yet contributed to help APC protect it — please think like a business owner: Support the campaign to keep cBHT available for the millions of patients who need it.

We’re still just about $300,000 $290,000 shy of raising the $1.5 million we need. We’ve done great so far, with online ads, podcast appearances, and print and television marketing ready to go. It’s a nationwide message that Congress and the FDA won’t be able to ignore … but only if we have the funds to get it out.

We’re this close. Help us hit that goal so we can protect cBHT, your patients, and your business.

4 things to know about APC’s cBHT media campaign

One for the money

We’ve raised $1,208,600 of our $1.5 million goal — so we’re just about $300,000 short, but almost there.

(Letco Medical’s $3-$5-$10 program — where online shoppers are encouraged to add a contribution to their Letco shopping cart — is off to a great start, with the first contribution coming at 7:03 am on day one of the campaign.)

Two for the show

  1. We’ve already arranged for appearances on 35 health podcasts — in fact, three have already aired, including the latest: Jim Hrncir on “Health Mysteries Solved,” answering “Can Unrelated Symptoms Hide Behind a Hormone Imbalance Diagnosis?
  2. A great incentive: We’ve completed production on two videos showcasing the essential role pharmacy compounders play in the American healthcare system. Anyone who invests $5,000 or more in the media campaign before we hit our $1.5 million goal can receive customized versions of those videos, FREE. Check out a sample:

Three to get ready

  1. APC members have downloaded more than 310 bag stuffers, posters, window clings, and other promotional materials from the members-only cBHT Tools page, A4PC.org/cbhttools
  2. Compounding.com already has more than 10,000 page views, and it’s trending upwards as word gets out.
  3. The message is getting to legislators. So far our ads have been seen by at least 146 U.S. representatives, U.S. senators, and state legislators.

Now go, go, go

Together is how we’re going to save compounded hormone therapy — we need you to do as much as you can!

  1. Speak to your vendor contacts about the threat to cBHT and urge them to contribute to the campaign — all the information is at Compounding.com.
  2. If you’re only partway to a $5,000 investment, make up the difference! That will get you those free, customized videos … if you invest before we hit our $1.5 million goal. (Click the image above for a sample.)
  3. Recruit your patients and prescribers to help save cBHT. Explain the issue and direct them to compounding.com where they can share their stories — stories that can make a difference with policy makers. (We’ve got the members-only tools to help you reach out at A4PC.org/cbhttools.)
  4. Write for us: We’re still looking for cBHT columnists with some solid insight into the use of compounded hormones for Compounding.com. If you can write some expert opinion with voice for patients and policy makers, drop a message to Scott Brunner at scott@a4pc.org.

Know them? Nudge them

Everybody who’s anybody is a member of APC, right? Well, not quite. That’s why we’re asking for your help in urging your compounding compatriots to join APC — whether it’s a co-worker across the lab, a competitor across town, or a colleague across the country. Simply put, there’s no more powerful recommendation than that from a friend.

So if you know them, nudge them. Ask if they’re APC members, and if they’re not, urge them to join their profession’s trade association. The place to direct them is A4PC.org/join. And if they use code APC2021, they’ll save $25!

Reuben answers the call

We asked you to blog for Compounding.com, and Reuben Nielsen of MedQuest Pharmacy in North Salt Lake, Utah, responded. Check out his post, “Relief, not pain: The typical manufactured hormone solution isn’t suitable for everyone.”

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