Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program

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Polsinelli Podcast Explores Upcoming Webinar

Covered entities and drug manufacturers expected the Health Resources and Services Administration (HRSA) to issue its much anticipated mega-reg for the 340B Program in June. Instead, the U.S. District Court for the District of Columbia in PhRMA v. HHS, et al., 1:13-cv-1501 (D. D.C.), kicked off the summer by invalidating HRSA’s orphan drug rule, and suggesting that HRSA lacked the statutory See more +

Polsinelli Podcast Explores Upcoming Webinar

Covered entities and drug manufacturers expected the Health Resources and Services Administration (HRSA) to issue its much anticipated mega-reg for the 340B Program in June. Instead, the U.S. District Court for the District of Columbia in PhRMA v. HHS, et al., 1:13-cv-1501 (D. D.C.), kicked off the summer by invalidating HRSA’s orphan drug rule, and suggesting that HRSA lacked the statutory authority necessary to issue the mega-reg. PhRMA has fought back against HRSA’s attempts to recast the orphan drug rule as interpretive guidance, creating additional questions about how HRSA uses interpretive guidance.

Rather than receiving much needed clarity for the 340B Program, covered entities and drug manufactures now operate in a less certain environment, with the mega-reg on hold indefinitely. This webinar will examine current issues surrounding the 340B Program, and will consider what covered entities and drug manufacturers can do to find the clarity necessary for 340B Program compliance amidst the present confusion.

For example, this webinar will discuss:

• 340B Program Litigation – How current litigation may affect the 340B Program, including PhRMA v. HHS, AIDS Healthcare Foundation v Douglas, CV 09-8199-R (C.D. Cal), and The Vaccine Center v. GlaxoSMithKline, et al., 2:12-cv-01849 (D. Nevada).

• The Mega-Reg – When will HRSA issue the mega-reg, how PhRMA v. HHS may affect it, and what OMB meetings and recent HRSA guidance may indicate about its content.

• Current Challenges ¬– What increased audit intensity by HRSA means for covered entities and drug manufacturers.

• Surviving the Current Environment – What practical steps covered entities can take now to succeed in the current environment.

Presenters include Travis Jackson and David Cade. To hear more about 340Bs. click on to the podcast. For information about the webinar, go to www.polsinelli.com See less -

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Topics:  340B, Covered Entities, Drug Manufacturers, HHS, HRSA, Orphan Drugs, PHRMA, Prescription Drugs

Published In: Health Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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