Topic
340B
257 published works
Health Care and Life Sciences
OIG Issues Report on 340B Contract Pharmacy Arrangements Supporting Need for Tighter Rules
By Constance A. Wilkinson, Alan J. Arville
By Constance Wilkinson, Alan Arville, and David Gibbons The U.S. Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") released a Report [1] on February 5th based…
Focus on Regulation
PhRMA Files Suit Challenging 340B Orphan Drug Final Rule
By Alice Valder Curran, Emily Gebbia
On Friday, September 27th, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit against the Department of Health and Human Services challenging the 340B orphan drug final rule. The…
Focus on Regulation
Senator Grassley Continues Scrutiny of 340B Program with Letter to Walgreens
By Alice Valder Curran, Christopher Schott
On Wednesday, Senator Chuck Grassley (R-Iowa) sent a letter to the President and CEO of Walgreens, requesting detailed information to “help better understand Walgreen’s participation as a contract pharmacy” in…
Focus on Regulation
340B Program: HRSA Releases Final Rule on Orphan Drug Exclusion
By Alice Valder Curran, Christie Bloomquist, Christopher Schott
HRSA released its final rule on the orphan drug exclusion this morning. The final rule is set to be published in the Federal Register tomorrow, July 23, 2013. The effective date…
Health Industry Washington Watch
340B Enforcement Activities
The Health Resources and Services Administration (HRSA) has announced plans to strengthen oversight of both covered entities and manufacturers participating in the 340B drug discount program to ensure compliance with…
Health Industry Washington Watch
GAO Examines Manufacturer Discounts Under 340B Drug Program
The Government Accountability Office (GAO) has issued an ACA-mandated report entitled "Drug Pricing: Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement." By way of background, the…
Health Industry Washington Watch
OIG Examines State 340B Drug Program Policies
The HHS Office of Inspector General (OIG) has released a report entitled "State Medicaid Policies and Oversight Activities Related to 340B-Purchased Drugs." By way of background, the 340B program limits…
Health Industry Washington Watch
HRSA Publishes Proposed Rule Regarding the Exclusion of Orphan Drugs for Certain 340B Covered Entities
This post was originally written for the Life Sciences Legal Update blog by Joseph W. Metro and Vicky G. Gormanly. On May 20, 2011, the Health Resources and Services Administration…
Life Sciences Legal Update
HRSA Publishes Proposed Rule Regarding the Exclusion of Orphan Drugs for Certain 340B Covered Entities
By Joseph W. Metro, Vicky G. Gormanly
On May 19, 2011, the Health Resources and Services Administration (“HRSA”) released a proposed rule concerning the exclusion of orphan drugs for certain covered entities under the 340B Program. The 340B…
Drug & Device Law
Will The Supreme Court Tackle a Plaintiff End-Run Around No Private Right of Action?
Okay, that's a klutzy title. The football obsession doesn't leave us until the morning after the Super Bowl. But the Iggles have been ignominiously bounced from the NFL playoffs, so…