From APC’s President

The hardest part

Michael Blaire, RPh, FIACP
APC President

The Administrative Procedure Act governs the process by which federal agencies develop and issue regulations. It includes requirements for publishing notices of proposed and final rulemaking in the Federal Register and provides opportunities for the public to comment on notices of proposed rulemaking.

The Regulatory Flexibility Act requires agencies to consider the impact of their rules on small entities and to evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities when the rules impose a significant economic impact on a substantial number of small entities. The Chevron Doctrine is an administrative law principle that compels federal courts to defer to a federal agency's interpretation of an ambiguous or unclear statute that Congress delegated to the agency to administer. If you are not familiar with these concepts, that is not surprising, as they inhabit the world of the federal court system and would be unlikely to appear in a movie or TV courtroom drama.

So why am I telling you this? Well, each is intended to add clarity and transparency to the regulatory process. And each was an issue raised in this week's oral arguments in Federal District court related to litigation filed against FDA by seven compounding pharmacies.

As you may recall, back in October 2020 a group of pharmacies (six of which are owned by APC members) sued the FDA, claiming the agency exceeded its authority by developing an MOU that upended long-standing regulations on compounding pharmacies. The lawsuit seeks to block the implementation of the final standard MOU, saying that the FDA bypassed congressional instructions in developing it.

Utilizing our Legal Defense Fund, APC was one of several groups that supported an amicus brief in support of the pharmacies. In March, FDA sought to end the suit claiming that the case is not ripe for judicial review. In effect, FDA claimed that since no one has been hurt yet, the case should not be heard until after the October 2021 implementation date. The pharmacies rebutted that the record demonstrates that they face a "substantial risk of future harm" regardless of whether the states in which they reside sign the MOU.

All of this brings us to the hearing last Wednesday, which was the first time a judge heard arguments over those dueling motions for summary judgment. I was fortunate to be able to listen in to the arguments. Both sides presented their arguments, and although I may be slightly biased, I believe that the pharmacies' attorney, Rachael Pontikes of Reed Smith, did a masterful job in making a compelling case and responding to the judge. Judge Christopher Cooper seemed knowledgeable and asked pointed questions to both sides (though I am still not sure that he fully gets the difference between dispensing and distribution). The proceeding lasted two hours and concluded with no indication as to how the court might rule.

The MOU is but one of the several existential issues confronting pharmacy compounding. Why am I really telling you this? So you'll know your association is in the fight, working hard for you and doing everything we can to secure your future. On a whole bunch of issues.

The MOU is a big one, and this was a big week. Let's hope the judge acts soon, as he indicated he would. Because as Tom Petty once said, "The waiting is the hardest part."

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 registration is OPEN

Do you know your member of Congress?
Shouldn't you? (Hint: APC can help)

When APC needs to get the attention of Congress — to sign a letter, vote on a bill, or simply to be aware of what's impacting compounding — the best way we can do that is through our members' personal connections with their representatives or senators.

That's why we're collecting a list of those members who already have such a connection with their federal legislators — from being lifelong friends to simply being comfortable calling them directly. If we need to reach out to a particular member on a particular committee, we'll know which APC members have the right relationship to reach out on behalf of the compounding profession.

We're also looking to help more members establish those relationships, because the closer our connection to Congress, the better we can serve the profession — and patients.

If you have (or want to establish) a connection with a member of Congress, please let us know. Clicking one of the options below will let you send a pre-filled email to APC — just add your pharmacy name and contact information.

• Yes, in fact I'm close friends with them and talk fairly often.
• Yes, I've met them several times and I’m comfortable contacting their office when needed.
• Yes, I've been in touch through their office at least once.
• No, but I would like to establish a professional relationship with APC's help.

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:

Henry Cuellar, Texas
Neal P. Dunn, MD, Fla.
Andy Biggs, Ariz.
Michael C. Burgess, MD, Texas
Earl L. “Buddy” Carter, Ga.
Warren Davidson, Ohio
Paul A. Gosar, DDS, Ariz.
H. Morgan Griffith, Va.
Diana Harshbarger, PharmD, La.
Jaime Herrera Beutler, Wash.
Ronny L. Jackson, MD, Texas
Markwayne Mullin, Okla.
Gary Palmer, Ala.
Scott Peters, Calif.
Mark Pocan, Wisc.
Chris Stewart, Utah

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: