However, FDA lacks funding to promptly respond to off-label promotion submissions on broad scale; model outlined in settlement of Amarin's Vascepa case could bolster support for third-party vetting system.
Structural and funding changes within FDA likely would be needed before the preclearance process accorded to Amarin Corp. PLC in the Vascepa (icosapent ethyl) off-label promotion litigation settlement could serve as a broader regulatory framework for such communications.
Alternatively, the settlement's model could bolster calls for an independent third-party body, sanctioned by FDA, to vet such communications in...
Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.
New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.
The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.
