“Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue: EpiPen’s classification as a generic drug for purposes of the Medicaid Drug Rebate Program (“MDRP”). Resolution of the classification issue carries significant risk for segments of the drug industry.
EpiPen’s Backstory and the MDRP
EpiPen is an epinephrine auto-injector for emergency treatment of anaphylaxis. The U.S. Food and Drug Administration (“FDA”) approvedEpiPen in December 1987 and currently lists it in the FDA National Drug Code Directory under a New Drug Application by its manufacturer, Mylan Specialty L.P. (“Mylan”). Following year-over-year price increases since Mylan acquired EpiPen in 2007, members of Congress now claim EpiPen originally was misclassified as a generic drug under the MDRP. Drug classification is significant, because generic drugs are subject to a substantially lower rebate than their brand counterparts, as explained in more detail below.
By way of background, Congress established the MDRP in 1990 as part of the Omnibus Budget Reconciliation Act, legislation enacted to help control the cost of Medicaid prescription drug coverage. For a drug to be eligible for Medicaid reimbursement, its manufacturer must enter an agreement with the U.S. Department of Health and Human Services (“HHS”) to pay rebates to states based on the utilization of the drug.”
Download this white paper to continue reading …
James W. Matthews is a partner and litigation lawyer with Foley & Lardner LLP. He focuses his practice on trying complex business disputes for a variety of businesses, including manufacturers of pharmaceutical products and medical devices.
Katy E. Koski is a partner and litigation lawyer with Foley & Lardner LLP. She is an experienced trial lawyer with particular experience defending pharmaceutical and other life science companies in large, multi-jurisdictional government investigations and litigations.
Jason Drori is a senior counsel in the Business Litigation & Dispute Resolution Practice of Foley & Lardner LLP. Mr. Drori concentrates his practice on the legal needs, business challenges, and regulatory pressures of the life sciences sector, particularly pharmaceuticals.
David Rosen is a partner and public policy lawyer with Foley & Lardner LLP. Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics.
Agenda
Faculty
Jason L. Drori
Foley & Lardner LLP
Jason Drori is a senior counsel in the Business Litigation & Dispute Resolution Practice of Foley & Lardner LLP. Mr. Drori concentrates his practice on the legal needs, business challenges, and regulatory pressures of the life sciences sector, particularly pharmaceuticals.
All of your training, right here at Lorman.
Pay once and get a full year of unlimited training in any format, any time!
- Live Webinars
- OnDemand Webinars
- MP3 Downloads
- Course Manuals
- Audio Recordings*
- Executive Reports
- White Papers and Articles
- Sponsored Live Webinars
Additional benefits include:
- State Specific Credit Tracker
- Members Only Newsletter
- All-Access Pass Course Concierge
* For audio recordings you only pay shipping
Questions? Call 877-296-2169 to speak with a real person.
Thank You!
Download White PaperMore Program Information
Access to all training products $699/year
Unlimited Lorman Training
With the All-Access Pass there is no guessing what you will need for your yearly training budget. $699 will cover all of your training needs for an entire year!
Easy Registrations
Once you purchase your All-Access Pass you will never be any further than one-click away from attending any Lorman training course.
Invest in Yourself
You haven't gotten to where you are professionally by luck alone; it's taken a lot of hard work and training. Invest in yourself with the All-Access Pass.
