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LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Stephen Mahinka, Phoebe Mounts, Alexis Miller, Kathleen Sanzo
Initial guidance provides insights on regulatory pathway for biosimilars, but does not address many critical issues.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Andrew Ruskin, Donna Lee Yesner, Stephen Ruscus
The Proposed Rule provides provisions that will significantly impact pharmaceutical manufacturers' rebate liability, price reporting calculations, and possibly their operations.
LawFlash/Client Alert | Class Actions LawFlash
Litigation Practice
Second Circuit sidesteps Concepcion and holds that the ability to enforce federal statutory rights mandates that a plaintiff be allowed to pursue a class action in court notwithstanding the parties' agreement to mandatory arbitration.
Presentation | Speech
Kathleen McDermott
Morgan Lewis's Kathleen McDermott presented "The Era of Individual Accountability-Is A Liability Hailstorm On The Way?" at the 2011 American Health Lawyer's Association Annual Meeting. Ms. McDe... more
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Alexis Miller
FDA draft guidance on responding to requests for off-label information foreshadows restrictive policies on use of social media.
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Rebecca Osowski, Kathleen McDermott, Jonathan Havens, Michele Buenafe
The Centers for Medicare and Medicaid Services' proposed rule, which will implement Section 6002 of the Patient Protection and Affordable Care Act, clarifies several definitions, provides further information on reporting requirements, and offers guidance on submitting required information.
Presentation | Speech
Stephen Mahinka
Topics presented include: Structural Changes in Pharmaceutical Industry Stimulating Focus on Comparative Effectiveness Research Potential Changes by Healthcare Reform Law Affecting Demand Levels and Prices/Payments ... more
Outside Publication | Article
Arianne Callender, Howard Young
Agencies' recent responses to Senate call for action on physician-owned distributors offer few details on policies. Stakeholders must await CMS rulemaking and OIG study for possible answers. more
Presentation | Speech
Howard Young
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Stephen Mahinka, J. Everett, Jr., David Brenneman, Albert Shay
The Federal Trade Commission (FTC) and Department of Justice (DOJ) (together, the Agencies) issued their final "Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Sha... more
Outside Publication | Article
Donna Lee Yesner
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Arianne Callender, Howard Young
Agencies' recent responses to Senate call for action on physician-owned distributors offer few details on policies. Stakeholders must await CMS rulemaking and OIG study for possible answers.
Presentation | Speech
Stephen Mahinka
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Phoebe Mounts, M. Elizabeth Bierman, Michele Buenafe
On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device."[1] Once ... more
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
M. Elizabeth Bierman, Michele Buenafe
On July 19, the Food and Drug Administration (FDA) issued a new draft guidance document, titled Mobile Medical Applications , describing FDA's position on the regulation of mobile applications, i.e., software applications inten... more
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Life Sciences and Healthcare Practice
On June 23, the U.S. Supreme Court issued a 6–3 decision in Sorrell v. IMS Health Inc., declaring a Vermont law designed to prevent data mining unconstitutional. The Vermont Prescription Confidentiality Law at issue restr... more
Presentation | Speech
Donna Lee Yesner
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Arianne Callender, Howard Young
In a strong signal that physician-owned distributors (PODs) may be in the line of enforcement fire, on June 9, five senators, representing the Committees on Finance, Aging, and Judiciary (Committees), signed joint letters to the... more
Outside Publication | Article
Kathleen McDermott, Arianne Callender
Outside Publication | Article
Heather Deixler, W. Reece Hirsch
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
FDA & Healthcare, Life Sciences, and Employee Benefits Practices
On May 31, the U.S. Department of Health and Human Services (HHS) released a notice of proposed rulemaking (Proposed Rule) creating a new requirement that covered entities produce an "access report" informing individuals of all ... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Howard Young, Daniele Capasso, Albert Shay
Recently, in United States v. Borrasi ,[1] the Seventh Circuit aligned with the Third, Fifth, Ninth, and Tenth Circuits in determining that the Anti-Kickback Statute (AKS)more
Presentation | Speech
Howard Young
LawFlash/Client Alert | FDA and Healthcare LawFlash
Lee Rosebush, Kathleen McDermott, Michele Buenafe
The State of Vermont regulates expenditures and gifts to healthcare professionals and entities by manufacturers of prescribed products (medical device, pharmaceutical, and biological products entities). Such entities with repor... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Kathleen McDermott, Arianne Callender
The U.S. Department of Health and Human Services (HHS) Office of Inspector General's (OIG's) Health Care Fraud Prevention and Enforcement Action Team (HEAT) has garnered headlines for its coordinated Medicare fraud criminal swee... more