August 9, 2013—More than 100 members of Congress (84 representatives and 29 senators) have signed letters to leaders of their respective chambers expressing their "bipartisan support" for the 340B drug discount program. … [Read more...]
Senator Hatch Criticizes 340B Orphan Drug Exclusion Rule
HRSA interpreted law incorrectly, he tells Administrator Wakefield in letterAugust 2, 2013—Sen. Orrin Hatch (R-Utah) has sent a letter to HRSA Administrator Mary Wakefield saying the agency's 340B orphan drug exclusion final regulation is "incorrectly interpreting the law" and diminishes incentives for orphan drug development. … [Read more...]
Senator Grassley Questions Walgreens About Its Participation in 340B
Seeks information about its role as a contract pharmacyAugust 1, 2013—Sen. Charles Grassley (R-Iowa) sent a letter yesterday to Walgreens requesting detailed information about its participation in the 340B program as a contract pharmacy, including its financial arrangements with covered entities. … [Read more...]
Our Response to the Drug Industry 340B White Paper
We recently released a comprehensive 27-page report that corrects misunderstandings about the 340B drug discount program promoted by the pharmaceutical industry. That report addresses misconceptions and unfounded accusations of the program. It also calls for a number of ways to modernize the 340B program. Now, as a follow-up, we are focusing narrowly on the unfounded … [Read more...]
New Orphan Drug Rule Makes Sense
Last week, federal health officials published a final rule for the 340B drug discount program that enables rural hospitals to continue stretching their dollars, serving more patients, and improving their services. The July 23 regulation by the Health Resources and Services Administration (HRSA) implements statutory language that limited 340B drug discounts on orphan drugs for … [Read more...]
HRSA Publishes Final 340B Orphan Drug Regulation
Rule Goes Into Effect October 1st, 2013Earlier today, HRSA published online its long-awaited final regulation to implement the 340B “orphan drug exclusion,” which limits 340B-purchasing for free-standing cancer hospitals, critical access hospitals, sole community hospitals, and rural referral centers participating in the 340B drug discount program. The final regulation mirrors HRSA’s May 2011 proposed rulemaking in … [Read more...]
White House Budget Office Clears 340B Orphan Drug Rule for Publication
Also, details emerge about HRSA's comprehensive 340B regulationJuly 17, 2013—The White House Office of Management and Budget (OMB) has finished its review of the long-awaited final regulation to implement health care reform’s partial limit on 340B discounts for orphan drugs, presumably clearing the rule for publication in the Federal Register. … [Read more...]