The drugs and devices have been on the market for years. But FDA-ordered studies still aren’t done.

“Doctors rely on this evidence, patients rely on this evidence, and if that evidence is not there, it’s going to lead to a lot of uncertainty."

Category	Detail
Condition	Postmarket Drug and Device Studies
Key Mechanisms	FDA mandates postmarket studies to evaluate long-term safety and efficacy of approved products.
Target Population	Patients using FDA-approved drugs and devices.
Care Setting	Post-approval clinical settings.

FDA-approved drugs often require postmarket studies that are frequently delayed.
Only 21 of 300 patients were enrolled in the Tavneos postmarket study as of last fall.
Dozens of liver damage cases have been associated with Tavneos.
Almost 600 postmarket studies are running behind schedule according to FDA data.
The FDA's new policy may increase reliance on postmarket studies.

Assess patient history and clinical presentation to identify potential adverse effects associated with drugs and devices.
Utilize diagnostic tests to monitor for complications, such as liver function tests for patients on Tavneos.

Consider alternative therapies if patients exhibit adverse reactions to postmarket studied drugs.
Implement a risk management plan that includes regular follow-ups and patient education about potential side effects.

Schedule regular follow-up appointments to monitor patient outcomes and side effects.
Encourage patients to report any new symptoms or concerns promptly.

Patients may be exposed to products that do more harm than good due to delayed studies.

Patients prescribed drugs or devices with pending postmarket studies.

Patients and doctors may lack clarity on the risks and benefits of these products.

Ensure timely enrollment and completion of postmarket studies.
Maintain transparency regarding the status of postmarket studies to inform patients and healthcare providers.

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