Our biopharma and medical device attorneys provide practical, solutions-oriented advice to a broad array of biotechnology, pharmaceutical, and medical device companies and other organizations in the life sciences industry.

We advise clients in the following areas:

  • Applying the federal anti-kickback statute and other fraud and abuse laws to clinical research activities
  • Implementing comprehensive Patient Support Programs
  • Following FDA advertising and promotion regulations, guidance, and warning letters; and reviewing in conjunction with product teams the advertising and promotion materials and field medical activities for both drugs and devices
  • Structuring and implementing domestic and international clinical trials and creating and operationalizing data and biospecimen repositories for research use
  • Responding to government or regulatory audits of research sponsors and investigators
  • Complying with the CMS Open Payments Program (also known as the Physician Payment Sunshine Act)
  • Complying with U.S. and foreign data protection laws and industry best practices (such as HIPAA, U.S. state privacy laws, the EU Data Protection Directive and General Data Protection Regulation (GDPR), and EU member states' implementing laws)
  • Applying government price reporting requirements (e.g., Medicare ASP, Medicaid AMP and BP, 340B) and consequences for pricing proposals, including value-based pricing arrangements

Firm Highlights

Blog

New IRS Determination Letter Program for 403(b) and 401(a) Plans

On November 7, 2022, the IRS issued Revenue Procedure 2022-40 , which allows certain tax-exempt employers (such as schools, charities, and churches) to apply for IRS determination letters on their individually designed section 403(b...

Matter

Elections and Constitutional Law: Successfully Challenged Certification of Initiative Petition

In a victory for consumers and the ride-hailing public, the Massachusetts Supreme Judicial Court recently barred the Secretary of State from placing on the November ballot initiative petitions proposed by companies such as Uber...

Blog

IRS Guidance Expands Access to ACA Premium Tax Credit, Allows Cafeteria Plan Sponsors to Permit Employees to Revoke Family Coverage Mid-year

Final Regulations under Section 36B of the Internal Revenue Code On October 11, 2022, the Internal Revenue Service (IRS) issued Final Regulations under Code Section 36B relating to eligibility for the Affordable Care Act’s...

News

Ruth Mattson quoted in Law360 article regarding new Massachusetts surtax

News

Verrill Welcomes Associates Brody Haverly-Johndro, Maye Emlein, Victoria Larson, Chris Petronio, Abby Plummer, and Alexander Read

Publication/Podcast

The PHE is Ending: Do You Know Where Your Waivers Are?

While the pandemic is not over, the COVID-19 public health emergency (PHE) is expected to expire soon, which means that a number of operational, safety, and billing standards that were waived at the beginning...

Event

Annual Update: Part 1 - 2022 Legal Year in Review (2nd Session)

Event

Annual Update: Part 1 - 2022 Legal Year in Review (1st Session)

Matter

Advised Fortune 500 Company on Group Health and Welfare Benefit Plans

We were engaged by a Fortune 500 manufacturing company to provide legal and compliance services regarding its group health and welfare benefit plans. During the course of our representation, we have advised the company...

Publication/Podcast

Maine PUC Clarifies Ability of Level 2 Projects to “Leapfrog” Level 4 Projects in Interconnection Queue

After months of uncertainty over the issue of whether Level 2 renewable energy projects can “leapfrog” Level 4 projects in the queue, the Maine PUC clarified one of the ambiguities. Specifically, in response to...

Contact Verrill at (855) 307 0700