All tagged pharma

Generic Drugs and the PTAB

When the Hatch-Waxman Act was passed into law in 1984, it established the generic drug industry and thereby forever changed the marketplace for prescription drugs. Today 80% or more of all prescriptions are filled with generic drugs, which has resulted in a savings of $1.67 trillion from 2007 to 2016.

"Right to Try" May Do More Harm Than Good

When the Senate approved the “Right to Try Act of 2017” on August 3, Republican sponsor Senator Ron Johnson hailed it as a law that helps “real people facing their mortality with no hope.”  The bill allows patients with “a life-threatening disease or condition” who have “exhausted approved treatment options” to go directly to pharmaceutical companies and request access to drugs or devices not yet approved through the traditional process.  The bill does not, however, require those drug companies to grant any such requests.  It also does not address how much drug companies can charge those patients for access. And the rhetoric hailing it as a savior for patients “with no hope” ignores the fact that the FDA already has an Expanded Access (Compassionate Use) procedure that allows patients to access investigational medical products outside of clinical trials.