The FDA’s Scrutiny on Desiccated Thyroid Extract
A longstanding treatment for hypothyroidism is under the FDA’s spotlight, raising concerns about its future availability. Desiccated thyroid extract (DTE), an animal-derived version of thyroid hormone, has been a go-to remedy for symptoms like fatigue, depression, and weight gain in hypothyroid patients since the 1890s.
While synthetic alternatives have dominated the market since the 1950s, a small percentage of patients still prefer DTE for its perceived effectiveness in symptom relief. However, recent reports of over 500 adverse events linked to DTE prompted the FDA to require regulatory approval for the hormone to ensure safety and quality standards.
Given that DTE was not subjected to modern regulatory processes due to its long history, the FDA’s move has stirred controversy among pharmacists and influencers, including those associated with the MAHA movement advocating for natural remedies.
Patient Preferences and Regulatory Challenges
Some patients opt for DTE over synthetic options due to its natural origin and perceived benefits. Despite recommendations from organizations like the American Thyroid Association to consider synthetic drugs as first-line therapy, a segment of patients remains loyal to DTE.
The FDA’s emphasis on tighter regulations stems from a surge in adverse events in 2019, possibly linked to inconsistent dosing in animal-derived products. While the agency plans to implement stricter controls on DTE, a grace period of around 12 months will allow patients to transition to approved alternatives like Synthroid by AbbVie Pharmaceuticals.
Industry Responses and Future Outlook
Companies like AbbVie, a manufacturer of DTE product Armour Thyroid, and Acella Pharmaceuticals are working towards FDA approval to comply with the new regulations. Acella’s CEO, Art Deas, acknowledges the challenges of obtaining approval within the given timeframe and hopes for continued access to DTE during the process.
Dr. Marty Makary, FDA Commissioner, has hinted at the possibility of allowing access to DTE until formal approval is granted, emphasizing the agency’s commitment to ensuring patient access. Acella is progressing towards a phase 3 trial and aims to secure approval to enhance confidence in their product and expand their market share.
While the future of DTE remains uncertain, industry players are navigating the regulatory changes while prioritizing patient needs and product safety. The ongoing developments underscore the importance of balancing tradition with regulatory compliance in the healthcare landscape.
