Congressman Michael Rulli, R-Salem, introduced legislation to protect access to an animal-derived thyroid medicine that the U.S. Food & Drug Administration expressed concerns about regarding its “safety and effectiveness.”

Rulli, whose district includes Mahoning and Columbiana counties, said: “Washington should not be in the business of taking away treatments that patients have relied on for generations. This is about common sense and basic access to care. At a time when more Americans are struggling with hormone-related health issues, desiccated thyroid extract has remained a safe, effective option for over 100 years. A sudden regulatory shift should not be allowed to put that treatment out of reach. We are standing up for patients, for providers and for the right to access proven care.”

But the FDA questions the safety of using DTE.

The FDA, which is under the U.S. Department of Health and Human Services, announced March 11 that it would issue guidance in August about DTE, which is used by 1.5 million people with thyroid conditions. The FDA states DTE is a biological product under the Public Health Service Act and not eligible for compounding by pharmacists.

The FDA said it has “concerns with the safety and effectiveness of unapproved animal-derived thyroid medications” — DTE is made usually from grounded pig thyroid glands and then dried and powdered for medical use — “because they have not been reviewed by FDA to ensure the safety, purity and potency.” Also, the FDA said it “has received complaints from patients and reports of adverse events related to the safety and potency of these unapproved medications.”

It added: “Unapproved thyroid medications have an increased risk of certain impurities due to the source — animal thyroid glands — or the way it is manufactured. These issues can lead to infections and other health concerns.”

Rulli’s bill would not classify DTE — used since the late 1800s — as a biologic solely because it contains a clinically inactive protein and align federal policy with the FDA’s guidance on inactive ingredients.

During an April hearing of the U.S. House Energy & Commerce Committee’s Health Subcommittee, of which Rulli is a member, the congressman brought up the DTE issue to HHS Secretary Robert F. Kennedy Jr., saying that this move would require patients to switch to more-expensive alternatives. Rulli asked Kennedy what led to the reclassification of DTE as a biologic.

Kennedy said: “I would say there is controversy within my agency about that decision and I am very, very happy to work with you on resolving it. I invite you to contact my office and contact me directly and I will work with you on that.”

The bill was referred to the Energy & Commerce Committee.

Rulli said he heard about the issue after meeting with pharmacists in the 6th Congressional District.

Rulli said: “One issue kept coming up again and again. Compounding pharmacists, many of them small business owners who have served their communities for decades, are being crushed by yet another out-of-touch regulation that ultimately hurts patients. This legislation is the direct result of those conversations and the real-world impact this reclassification is having.”

The legislation is supported by the National Community Pharmacists Association, the Professional Compounding Centers of America and the Alliance for Pharmacy Compounding.

The APC said the FDA’s change is “a fundamental contradiction of the agency’s own framework and one that the agency hasn’t come close to adequately justifying,” and the change would offer “no immediate alternative for patients, leaving a very real hole in continuity of care.”

The American Thyroid Association said the FDA’s “identification of significant violations of current good manufacturing practice for DTE products is alarming. However, removal of the DTE from the marketplace during a potentially lengthy biologics license application would leave patients without access to DTE for an unknown period of time.”

It added: “A regulatory approach that ensures the highest standards for DTE safety and reliability will ultimately benefit patients.”