HCQ for Covid? Courts won’t force FDA’s hand
ICYMI: Two federal courts separately denied requests from plaintiffs who wanted to force FDA to authorize the use of hydroxychloroquine to treat or prevent Covid-19 — despite the fact that there is little to no evidence that it works, and may even be dangerous.
FDA says physicians can prescribe it for Covid, but only off label; it doesn’t want to try to practice medicine:
“FDA generally does not seek to interfere with the exercise of the professional judgment of health care providers in prescribing or using, for unapproved uses for individual patients, most legally marketed medical products.”
The plaintiff’s arguments were unusual, to say the least. In one case, the Association of American Physicians & Surgeons argued (among other things) that it was injured “because it had to cancel one of its conferences due to state mandates prohibiting large public gatherings.”
In the other, a man argued that “FDA was effectively holding him and his elderly father hostage by not authorizing the ‘prophylaxis [sic]’ use of hydroxychloroquine.”
Raw material substitution?
The new blog post from Gus Bassani, PCCA’s chief scientific officer, explains “Why Brand and Generic Substitution Is Not the Same as Raw Material Substitution” — definitely worth a read.
You already know to get your ingredients from reputable repackagers and manufacturers, but Bassani explains that substitutability is a bit of a different creature. “USP specifications,” he explains, “may not cover every important aspect of a raw material.”
Check out the whole story.
CCHV: It ain’t over
Compounders on Capitol Hill is still going on — we’re in the midst of our 55 virtual congressional meetings, and we’re getting great feedback as we’re having our voice heard loud and clear.
Fighting the Tricare clawbacks, getting a better MOU for states, seeing the animal-compounding GFI withdrawn, and keeping that flawed NASEM study from influencing policy — those are the issues we’re talking with key members of Congress about … and we’ve got their attention.
Don’t forget to check out the issue briefs we’ve put together so you can stay informed.
As always, we’ll keep you updated by email and on A4PC.org!
A joint letter to protect cBHT access
Three major pharmacy associations — APC, NCPA, and NASPA — have submitted a joint letter today to the FDA, expressing concern about the NASEM study of cBHT and FDA’s stated intention of considering restrictions based on that study.
The letter points out deficiencies in the NASEM committee (e.g., the lack of anyone with expertise in either compounding or hormone therapy), how the committee overreached its assignment (notably by recommending that most cBHT hormones be considered for FDA’s difficult to compound list), and how the committee somehow recommended limits on cBHT despite never identifying “any pattern or significant quantity of adverse events that warrant such aggressive and punitive recommendations.”
The letter is part of a multi-pronged approach APC and our partners have been taking since the NASEM study was released in May, aimed at ensuring that millions of Americans do not lose access to these critical compounded medication.
You can read the joint letter here.
Help these urologists improve ED treatment
Urologists at Wake Forest University are working to improve the use of intracavernosal Injection (ICI) for erectile dysfunction — they’re looking for help from compounders to improve understanding among urologists relative to ICI, “and to try and standardize our delivery of care relative to treatment and education.”
What they told us:
A number of providers prescribe items like Trimix, with no thought given to the particular formulation or implications. Many older physicians will use “stampers” with rarely used formulations, many of which may be far below the more commonly used recipes. Concepts like thresholds for batch testing and even timelines for stability based on refrigeration/frozen storage are poorly understood by many prescribers.
We hope that input from compounding pharmacists can help urologists be more efficient with prescribing ICI for patients. The aim is to collect the information on the survey and compile it into a number of abstracts and manuscripts to consolidate the literature on ICI. In order for us to move ahead expeditiously, we are making a deadline of October 17. Thank you for your support of advancing the scientific knowledge for ED therapy.
Click here to take the survey.
Bray earns first annual Malmberg Compounding Advocacy Champion Award
(Press release) Jeffrey Bray, CPhT, of Salt Lake City, was the recipient of the Alliance for Pharmacy Compounding’s first annual George and Lucy Malmberg Compounding Advocacy Champion Award, presented to him at APC’s Compounders on Capitol Hill event on September 10.
The Advocacy Champion Award is presented annually to a pharmacy compounding professional who in the previous year has demonstrated “distinguished and extraordinary advocacy and political engagement in support of the pharmacy compounding profession.” That includes efforts to promote the enrichment of public health policy related to pharmacy compounding and the betterment of the pharmacy compounding profession and the millions of patients it serves.
It is named for George and Lucy Malmberg, both compounding pharmacists, who founded Wedgewood Pharmacy in 1981 and grew it into one of the largest compounding pharmacies in the United States and one of the leading pharmacies in animal health. The late George Malmberg’s advocacy on behalf of pharmacy compounders is legendary in the profession, and his wife Lucy has continued that legacy.
“Jeff Bray takes advocacy on behalf of his business and your profession seriously,” said Lucy Malmberg, who presented the award to Bray, “as seriously as George and I ever have.”
Bray is an accomplished pharmacy executive with more than 20 years of experience in the compounding and community pharmacy industry. He currently serves as the CEO of MedQuest Pharmacy, a nationally recognized full-service retail compounding pharmacy licensed in all 50 states. Jeff’s entrepreneurial spirit has earned him numerous awards including the Utah Business “Forty Under 40” and the APhA Foundation “Pharmacist Rx Superhero Award.”
Over the past four years, Bray has shown himself to be a remarkable advocate for the profession of compounding pharmacy. He has initiated or participated in dozens of face-to-face meetings with members of Congress, including travelling to Washington, D.C., repeatedly at his own expense. He and MedQuest pharmacy also hosting dozens of members of Congress at their beautiful compounding facility in North Salt Lake. One relationship at a time, he has built remarkable credibility with member after member of Congress who has influence over compounding policy. The result is a cultivated level of trust that serves both compounders and their patients.
We’ve got some friends in Congress coming to our aid to preserve compounded hormone therapy
Four representatives — Jaime Herrera Beutler, Henry Cuellar, Mark Pocan, and David P. Roe, M.D. — have written a letter to FDA Commissioner Stephen Hahn expressing their concern with the NASEM report. That’s the FDA-commissioned “study” that suggested limiting the availability of cBHT, despite the fact that it is used successfully by millions of people.
“[W]e ask the agency to consider the severely negative impact some of NASEM’s recommendations would have on patients,” they wrote, laying out some of the very issues APC has been pointing out since the NASEM report came out.
Their top point: “Doctors and patients should decide the best therapy.” It’s that simple (although we would add “pharmacists” to that list).
WE NEED YOU: Ask YOUR member of Congress to sign on to the letter. A phone call or message, “Please sign the Pocan letter to FDA about compounded hormone therapy” can make a difference.
Read the Pocan et al letter itself here.
Read APC’s brief on the issue here.
Pharmacists to be allowed to give Covid-19 vaccine
Great news: HHS is preemptively authorizing pharmacists and pharmacy interns across the country to administer any approved Covid-19 vaccine to patients 3 and older. (This follows the agency’s August 19 announcement that it was authorizing pharmacists to provide all CDC-approved vaccines.)
As with the August announcement, this rule applies across the country, and supersedes state laws that may limit pharmacist delivery of vaccines either by vaccine or by age.
The Pharmacy Times news story is here.
Where will you be tomorrow?
You want to be able to ship meds out of state?
You want to continue to supply veterinary compounds?
You want cBHT to stay legal?
THEN SAY SO.
If you don’t add your voice, compounding can lose these fights.
So step up. Defend your business to the members of Congress who will make a difference. You don’t even have to leave your living room.
Tomorrow: Get briefed on the latest at CCH Virtual: https://a4pc.org/cchv
Then: Come to one or more virtual congressional visits with key members of Congress through October.
Change won’t happen unless we MAKE it happen.
Sign up now: A4PC.org/cchv
Help your patients fight Covid-19
“The long muscle fibers that keep hearts beating were diced into short bits” — that’s what even mild cases of Covid-19 can do.
Help your patients protect themselves from Covid-19 and serious, life-long heart and lung damage. Masks and distance are critical, but there are supplements and lifestyle changes that can protect them and their families.
Learn what can help prevent Covid-19, and even what can help treat it with a one-hour virtual CE webinar, “COVID-19 and What You can Do For Your Immune System (and Your Patients)”.
It’s Tuesday, September 29, from 2:00 to 3:00 EDT. $55 for APC pharmacist members, $30 for technician or student members.
Get the details at https://a4pc.org/COVIDimmune.
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