Here’s some crucial 340B news—along with a perfect illustration of why the 340B drug discount program urgently needs fundamental reform and oversight.
Amgen just announced that
Neulasta purchases by 340B covered entities must be made exclusively from such specialty distributors as AmerisourceBergen’s ASD Healthcare business. Despite loud protests from the Safety Net Hospitals for Pharmaceutical Access (SNHPA), the Health Resources and Services Administration (HRSA) has reportedly decided that Amgen’s distribution plan “will not violate the 340B statute.”
This is a major decision for all pharmaceutical manufacturers that provide discounts to 340B entities. Want to know about HRSA’s guidance? Too bad.
Following in the sad footsteps of other barely-accountable government bureaucracies (IRS, NSA, Justice Department), HRSA has labeled its decision “top secret” and won't release any regulations or public rulemaking about manufacturer distribution strategies. Instead, HRSA continues to operate the 340B program through a tangle of sub-regulatory guidance that is not readily available for public comment or review.
Read on to learn more about Amgen's plan, SNHPA's complaints, and HRSA's "decision."
Posted by Drug Channels Institute, an HMP Global company on Wednesday, June 19, 2013