CALL TO ACTION: Urge Congress to co-sign the letter to FDA
Several states have already said they’re unable to sign the MOU due to their existing laws — or simply because it requires legislative action that can’t happen in time.
That’s why Reps. Henry Cuellar and Neal Dunn are asking fellow congressmen and -women to sign their letter — a letter to be sent to FDA requesting a delay in the MOU’s implementation. Read the letter yourself here.
The CALL TO ACTION: We must get our representatives to add their names to that letter. Send an email. Make a phone call. Visit the district office. Do whatever it takes to get the message out and a signature on the letter.
THE LETTER CLOSES FRIDAY THE 25TH, so we have ONE WEEK to get those co-signers. Don’t wait! Right now, make that call or send that email. It takes five minutes, tops, to say, “I’m a constituent and I’d like to ask Representative ______________ to respond to the Cuellar-Dunn letter.”
FDA has waited 24 years to implement the MOU. It can surely wait one more.
Steri-Tek, Topi-CLICK add $20,000 to cBHT campaign
We’re so close — we need you now. APC’s cBHT Media Campaign has received a pair of $10,000 gifts to the campaign — one from Steri-Tek and one from Topi-CLICK/DoseLogix. This is amazing news, and we owe both companies a big thank you.
This means we’ve raised about $1.16 million of the $1.5 million we need for a full campaign launch — we’re still more than $300,000 short of the goal. If we don’t meet that goal, it will mean much of the work and money we’ve put into the campaign will go to waste. We’ll have plenty of content, but not enough funding to get the word out nationally.
PLEASE: If you haven’t yet supported the campaign to save cBHT, we need you now. Time is running out. If every pharmacy compounder contributed just 1 percent of their cBHT business, we’d have hit our goal long ago. That’s all we’re asking: 1 percent to protect the other 99 percent.
Remember, if you make your contribution by June 30, Medisca will match it. You’ll double your impact. So please, do it today.
Board approves new ‘company’ APC membership
Among decisions the APC Board of Directors made when it met this past Tuesday was approval of a new “company” membership category. The aim is to roll out the new membership in January 2022.
“For our entire 30-year history, we’ve been an individual-membership organization, and when the number of compounders was greater, it’s a model that worked,” said APC’s CEO Scott Brunner. “But continuing consolidation in the business, coupled with new and thorny policy challenges, means that old model cannot sustain APC. Company memberships will allow us to represent many more voices while providing additional revenues to fund our advocacy work.”
Under the proposal the board approved, the new membership will be in the name of the pharmacy or outsourcing facility, and all employees will become APC members. Dues will be based on the total number of pharmacists and technicians the company employs, and company members will be eligible for a range of value-add services, included in the dues, that are not available to individual members.
“Now that the board has approved it, we’ll begin to build out the system,” Brunner said. “Our aim is to be able to make the services delivered via a company membership so attractive that it will be hard for a pharmacy or facility owner to say no to it.”
Help end DIR fees!
APC has signed onto a letter of support for the sponsors of H.R. 3554 and S. 1909, the Pharmacy DIR Reform to Reduce Senior Drug Costs Act. But we need more than just thanking the sponsors — we need more sponsors!
We know you’re busy, so our friends at NCPA are making it easy. One click is all you need. Go here to contact your senators and representative and urge them to support bipartisan pharmacy DIR reform efforts by cosponsoring S. 1909/H.R. 3554, the Pharmacy DIR Reform to Reduce Senior Drug Costs Act.
Pharmacy DIR fees grew 91,500% between 2010 and 2019, more than doubling between 2017 and 2019. Ridiculous? You bet it is. DIR fees are out of control and are unsustainable.
We need your help! Voice your support for this important legislation for community pharmacy.
Connecticut pharmacists — quit your day job?
The Connecticut Department of Consumer Protection is looking to hire a Consumer Protection Drug Control Principal Agent to work with the state’s potential upcoming cannabis marketplace. Click here for info and to apply — you have till June 30.
$1.5 million … or bust?
These are the end times, and we’re not talking theologically.
We’re in the last days of our effort to raise $1.5 million that will fund an ambitious media campaign to preserve patient access to compounded hormones. We’ve already raised more than $1 million, but we’re still $450,000 short of the funding needed for the actual media ad placements related to the campaign. And we only have about three more weeks to raise those funds. If we don’t make the goal, we’ll have to halt the campaign.
Many of you have already invested in this effort. Thank you. But I need to ask one thing more of you. While a handful of vendors in the compounding space have given to the campaign, many have not. They may not understand that the loss of cBHT to your pharmacy or facility could well mean they’ll lose your business. You need to remind them. In the next three weeks. And urge them to make a generous investment in your future … and theirs.
Here’s a list of who’s given to the campaign already. And here’s where vendors can go to invest in this important effort.
Thanks for your help. We’ve got three weeks. It’s $1.5 million … or bust.
Scott Brunner, CAE
Chief Executive Officer
PCAC recommends three substances for 503A bulks list
FDA’s Pharmacy Compounding Advisory Committee met Wednesday, voting to recommend adding melatonin, methylcobalamin, and oxitriptan to the 503A bulks list.
PCCA’s AJ Day, a member of APC’s Board of Directors, presented on behalf of APC and NCPA in support of recommending including methylcobalamin on the list. (FDA staff had recommended that methylcobalamin not be included, but PCAC members disagreed.)
Among the committee’s actions:
- Melatonin, typically used for treatment of sleep disorders in patients with autism spectrum disorder (specifically children and adolescents), was recommended on a vote of 13-0.
- Methylcobalamin — notably a treatment for amyotrophic lateral sclerosis, pain management (peripheral neuropathy, including diabetic neuropathy), inborn errors of metabolism, hyperhomocysteinemia, vitamin B12 deficiency, and autism — was recommended by a vote of 9-5.
- Oxitriptan, also known as 5-hydroxytryptophan or 5-HTP and often used for treatment for patients with tetrahydrobiopterin deficiency, was recommended by a vote of 11-0-1.
- Finally, choline chloride, commonly used for treatment of liver diseases, atherosclerosis, fetal alcohol spectrum disorder, and supplementation in long term total parenteral nutrition, was not recommended by a vote of 2-11-1.
After the meeting, Day sought to manage expectations. “It’s just a committee vote,” he said. “FDA can still decide whatever it wants.” He also emphasized that the items were nominated, evaluated, and discussed for specific uses, but if FDA places them on the 503A bulks list, it will not be for specific uses. FDA may put parameters on the route of administration, but not the use/diagnosis. How quickly FDA will act on the PCAC recommendations is not known.
NCPA to provide in-kind support to cBHT campaign
The National Community Pharmacists Association will provide in-kind support valued at $25,000 for APC’s cBHT media campaign, APC learned this week. That support will include ongoing coverage of the campaign and ad placements in NCPA’s flagship America’s Pharmacist magazine, social media, and other communications support, and exposure at NCPA’s October annual convention in Charlotte, N.C.
“We support this important campaign and we want to help make it successful,” wrote NCPA CEO B. Douglas Hoey.
“We’re grateful for our ongoing partnership with NCPA on compounding issues, and NCPA’s in-kind support of our campaign to save compounded hormones is particularly appreciated,” said APC’s CEO Scott Brunner.
If you’re also an NCPA member, look for campaign messaging coming soon – and maybe shoot Doug a quick thank you!
Help us gather shortage data on HCG
FDA has granted a request from APC and the Outsourcing Facilities Association for a listening session related to restrictions on compounding HCG that have resulted from the March 2020 reclassification of the drug as a biologic. That listening session is set for July 20.
Because HCG does have a drug monograph, the restriction creates a conflict of laws and stands to deprive some patients of an otherwise viable treatment option.
Between now and July 20, APC is gathering documentation of shortages or other interruptions in availability of HCG products from wholesalers and distributors. That documentation must come from compounding pharmacies and outsourcing facilities like yours. We’re speaking here not of your own internal documentation, but of documentation directly to you from the wholesaler or distributor, either in writing or via screen shots of the vendor’s software. Please scrub any examples you share with us to remove confidential pricing or other data.
In addition, note that we need ongoing documentation, not only a single point in time. Best to begin to collect the data, say, weekly, and share it with us prior to July 20.
APC will hold confidential all sources and senders of HCG shortage/unavailability data.
Send documentation to email@example.com, and mark it as “HCG shortage documentation.”
MedQuest hosts Rep. LaHood
Rep. Darin LaHood (IL) visited MedQuest Pharmacy in Salt Lake City. He’s a previous sponsor of APC priority legislation, so owner Jeff Bray thanked him during the tour of the pharmacy.
Pharmacist Ryan Young (left) and Rep. LaHood
YOU should invite a legislator to tour your pharmacy. Click here for our how-to guide!
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