Representative Abe Hamadeh (R-AZ) is writing to Food and Drug Administration (FDA) Commissioner Dr. Martin Makary over potential restrictions to popular thyroid medications.
For additional context, the FDA announced earlier in August that they would potentially "take action against marketed unapproved animal-derived thyroid (ADT) products (sometimes described as desiccated thyroid extract [DTE] products)," as Medscape described.
The action was noted as not taking place immediately, as the FDA intends to allow patients using these animal-derived thyroid medications to transition to approved, albeit synthetic, products, as no ADT currently has FDA approval, despite intentions to approve one. However, this sparked backlash on social media.
In his letter, Rep. Hamadeh said, "Many of these patients have found desiccated thyroid medications to be more effective than synthetic alternatives for managing their thyroid conditions," adding, "Any disruption to their treatment regimens could have serious health consequences and undermine the doctor-patient relationship."
As a result, he demanded answers to several questions by September 5th, asking what action the FDA plans to take against these ADT products, the justification for those restrictions, any consideration of potential fallout, and how the FDA will continue to ensure that patients receive effective thyroid medication.
"I have heard from veterans, mothers, and other individuals in my district, who believe their health will be negatively affected by the elimination of these medications," Rep. Hamadeh continued. "They have all shared their positive experiences with these drugs and their belief that their quality of life could be negatively impacted without them. This is of deep concern to me."
The Arizona Congressman further stated he has "confidence that Dr. Makary and his team will give serious consideration to the concerns of these patients, and I look forward to providing his team's answers to my constituents."
"The FDA's primary mission should be ensuring drug safety and efficacy, not unnecessarily restricting access to medications with established track records of safety and effectiveness, and I believe the Trump administration is committed to that mission," Hamadeh concluded.
On Friday, Senator Ruben Gallego (D-AZ) similarly wrote to the Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz, urging safeguards to prevent Medicare Part D prescription premium hikes.
