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Federal Right-To-Try Law Allows Patients to Access Experimental Medicines

January 30, 2019 Media Mentions

On January 30, Bloomberg Law published an article entitled, "Medical Centers Need Policies for Right-to-Try Oversight," discussing how a federal experimental medicines access law, meant to get around FDA regulations, gives patients with life threatening conditions opportunities to try unapproved drugs. Verrill Dana Health Care & Life Sciences attorney Kate Heffernan explains how the law, more commonly known as the right-to-try, also does not discuss how institutions' oversight functions factor into the process.

To learn more and hear Kate's thoughts, visit Bloomberg Law's website here.

Firm Highlights

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Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

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Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...

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Common Rule

Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.

Publication/Podcast

“If I've told you once, I've told you eight times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Overpayments

News

Michael K. Fee to Lead Verrill’s Nationally-Recognized Health Care and Life Sciences Practice Amidst Recent Changes

(August 31, 2020) – Verrill is pleased to announce Michael K. Fee as the new leader of Verrill’s nationally-recognized Health Care & Life Sciences Group. The Group has a long history of representing a...

News

Nearly 80 Verrill Attorneys Recognized by Best Lawyers® 2021, Including a Dozen Named Lawyers of the Year

(August 24, 2020) – Nearly 80 Verrill attorneys were recognized as "Best Lawyers" by Best Lawyers® 2021 , including 12 attorneys named “Lawyer of the Year,” a distinguished recognition for only a single lawyer...

Publication/Podcast

340B Providers Get Partial Relief from New Dispute Resolution Regulation

1. 340B ADR Process Established At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical manufacturers...

Publication/Podcast

The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare...

Publication/Podcast

HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered...

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European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...

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