Category Archives: Orphan Drugs

Subscribe to Orphan Drugs RSS Feed

PhRMA 2-0 in The Orphan Drug Wars

U.S. Federal District Court Judge for the District of Columbia, Rudolph Contreras, ruled Wednesday, October 14, 2015 that manufacturers need not offer 340B discounts for orphan drugs sold to a specified group of covered entities (CEs), regardless of how the orphan drug is used. To make a very long story short, in 2010, the Patient Protection … Continue Reading

Finally! HRSA Proposes Manufacturer Civil Monetary Penalties

On June 17, 2015 the Health Resources and Services Administration (“HRSA”) finally published its much anticipated proposed rule, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. Comments must be submitted via the online portal, email, or US Mail by August 17, 2015. Keep in mind, all submitted comments will be … Continue Reading

Near Miss on Congressional Overhaul of 340B Program

In just a matter of days, changes to the 340B Program were proposed and then withdrawn from H.R. 6, The 21st Century Cures Act. Had hospitals, health systems, and related lobbying groups not been closely watching the Act, the changes might have quietly gone through when the 21st Century Cures Act was unanimously passed out of Committee on May 21, 2015. The 21st Century Cures initiative, advanced by the House Energy … Continue Reading

340B Program Covered Entities: Some Items for Your Worry List

When 340B covered entities contemplate the future, they can find a number of issues to worry about. Here is a thumbnail on some of them. Orphan Drugs There is a possibility that the orphan drug issue will be resolved unfavorably to covered entities. That issue arises out of a 2014  court decision, Pharmaceutical Research and Manufacturers … Continue Reading

The Message Is Clear from OPA Director Pedley

Covered entities should be constantly preparing for  audit.  That  was the message, loud and clear, from Office of Pharmacy Affairs Director, Cmdr. Krista Pedly, who spoke by webcast  at the recent Winter Conference of the 340B Coalition in San Francisco.  That preparation, she said, should include making use of the compliance tools available through Apexus … Continue Reading