Kudos to Dr. Bruce Siegel for his commentary in Modern Healthcare explaining why 340B savings should stay where they belong—with patients and communities. Allowing 340B savings "to revert to drug companies, or to go toward other uses, would pull the thread of the 340B program and unravel the fabric of essential health services for entire communities," writes Siegel, the … [Read more...]
PhRMA Says HRSA Misinterprets 340B Orphan Drug Exclusion
Asks court to declare interpretive rule invalidFebruary 26, 2015—The Department of Health and Human Services Health Resources and Services Administration cannot second-guess Congress and rewrite the 340B orphan drug exclusion "to make the statute correspond with the agency's policy preference," brand-name drugmakers said yesterday in a court filing. … [Read more...]
House Subcommittee Holding 340B Hearing Next Week
Will hear from government witnesses on March 5February 25, 2015—The House Energy & Commerce Health Subcommittee has scheduled a hearing on the 340B program for March 5 at 10:00 a.m. … [Read more...]
Record Breaking 49 Orphan Drugs Approved in 2014
New filing by PhRMA in 340B lawsuit is due by Feb. 25February 19, 2015—In another sign of orphan drugs' rising prominence in drugmakers' portfolios, an industry blog reports that the Food and Drug Administration approved 53 percent more orphan products in 2014 than in 2013. … [Read more...]
More Details Emerge on 340B Audit of Drug Manufacturer
Fairness of allocation procedures also being examinedFebruary 12, 2015—More information about the first 340B program audit of a drug manufacturer emerged today during a drug industry government pricing conference in Washington. … [Read more...]
340B Keeps Dollars from Pharma R&D?
Big Pharma says that lost profits from the 340B drug discount program impact investments in research and development. Really? That doesn’t square with a new Vox infographic that shows nine out of 10 major pharmaceutical companies spent far more on sales and marketing than R&D in 2013. Johnson & Johnson spent $8.2 billion on research and development but blew more than … [Read more...]
Hospitals Back HHS in 340B Orphan Drug Lawsuit
Groups file briefs defending HRSA's interpretive ruleFebruary 11, 2015—Hospital groups have asked a federal district judge to dismiss the drug industry's lawsuit challenging the 340B orphan drug exclusion interpretive rule. … [Read more...]