YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to be licensed according to a national standard.
A handful of bills that comprised a healthcare reform package championed by Florida House Republicans are on their way to the governor’s desk where they’ll likely be signed into law.
The New York State Drug Take Back Act (Act), which was signed into law on July 10, 2018, went into effect on January 6, 2019.
Although federal efforts on drug pricing remain at the proposal stage, recently enacted legislation in six states on drug price transparency requires pharmaceutical manufacturers to review and update their approaches to prescription drug pricing and price increases on an ongoing basis to ensure compliance with state laws.
The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Federal Right to Try Act), signed into law on May 30, creates a federal framework for patients to access investigational new drugs without enrolling in clinical trials and without FDA expanded access approval.