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FDA proposes licensing standards for drug wholesalers

FDA proposes licensing standards for drug wholesalers

More than 30 years ago, U.S. law mandated state licensure of prescription drug wholesale distributors, resulting in a patchwork of varying state requirements and practical burdens for multi-state businesses. In 2013, Congress passed the Drug Supply Chain Security Act (DSCSA), which was intended to strengthen the integrity of the pharmaceutical distribution supply chain and to

Biosimilars are key to competition

Biosimilars are key to competition

It has been a big fall for interchangeable biologics. President Biden’s Executive Order 14036, “Promoting Competition in the American Economy” directed the Department of Health and Human Services (and the Food and Drug Administration), and HHS subsequently published its “Comprehensive Plan for Addressing High Drug Prices.” Interchangeable biosimilars are front and center in both of

Fulfilling interchangeables’ promise will take work

Fulfilling interchangeables’ promise will take work

Pharmacy-substitutable biologics, known as interchangeables, have long been little more than an idea. Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) created a dual pathway for follow-on biologics — with biosimilars that are prescribed by name by a health care provider and interchangeables that can be automatically substituted at the pharmacy —

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