Stakeholders Urge FDA to Protect Access to Compounded Hormone Therapies

Prescribers signed a letter expressing concerns about recommendations for restrictions on compounded hormones, which millions of women and other patient populations rely on.

Stakeholders throughout the pharmacy space are urging the FDA to ensure consistent access to compounded hormone therapies for the patients who need them. A group of 1957 prescribers of compounded hormones recently sent a letter to FDA Commissioner Robert Califf, MD, asking the agency to carefully consider any action that would restrict access to these medications.

“We are deeply concerned that [the] FDA may consider restricting access to compounded hormones—life-enhancing therapies that patients have relied on for years—and that it may do so based on a flawed 2020 report it commissioned from the National Academies of Sciences, Engineering, and Medicine,” the letter stated.

Alliance for Pharmacy Compounding CEO Scott Brunner said the letter is similar to input provided to the FDA from pharmacy associations, members of Congress, and patient organizations expressing concerns regarding bias, conflicts of interest, and a lack of scientific rigor in the FDA-funded National Academy of Sciences, Engineering, and Medicine (NASEM) report on compounded hormones.

“This threat to patient access and care is one that concerns not only compounding pharmacists, but also prescribers, who stand to be deprived of certain longstanding therapies that are benefitting their patients if FDA restricts compounded hormones,” Brunner said in a press release. “This letter is an expression by prescribers of that concern.”

Prescribers who signed the letter noted that the NASEM report includes recommendations for wide restrictions on compounded hormones, which millions of women and other patient populations benefit from and rely on.

“Those patients benefit greatly both from the availability of commercially available hormone products and from access to the compounded bioidentical hormone replacement therapies we prescribe for them. In many cases, commercially available hormone products simply are not suited to a patient’s need. In that instance, physicians’ ability to prescribe a compounded therapy customized for a specific patient is medically necessary to maintain that patient’s health,” the letter states.

Further, the prescriber letter emphasizes that access to compounded medications give prescribing physicians the ability to uniquely tailor and personalize medications that meet the needs of each patient they deem as being unsuitable for commercially available drugs.

“For example, when necessary, medical providers often prescribe a compounded alternative with a different dosage level, a different delivery method, or a different combination of hormones than what is available in manufactured products. Furthermore, some patients may have an allergy or intolerance to a manufactured product, which necessitates a compounded medication,” the letter states.

Brunner noted the importance of compounded medications and the role they play for patients who need individually targeted care.

“Without that ability for prescribers to customize certain dosage forms and strengths, many patients would simply be out of luck,” Brunner said in the release. “That’s precisely why Congress carved out an essential role for compounded medications in the Food, Drug & Cosmetic Act in the first place.”

The prescriber letter expresses support for improved education efforts on the use of bioidentical hormones for all health care practitioners who provide patient care. They also support creating a reasonable, consistent framework for adverse event reporting for compounded medications.

“APC stands ready to work with FDA in collecting and assessing patient-reported outcome data related to compounded hormone therapy, because we believe that data validates that compounded hormone therapy is helping patients live healthier, fuller lives,” Brunner said in the release. “We’re also willing to work with FDA to develop a state-based adverse events reporting regime for compounded medications.”

Reference

Prescribers urge FDA: Preserve access to compounded hormones. Alliance for Pharmacy Compounding. News release. Accessed September 13, 2022. https://www.globenewswire.com/news-release/2022/08/24/2504135/0/en/Prescribers-urge-FDA-Preserve-access-to-compounded-hormones.html