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

HIPAA Privacy Rule Changes: Just in time for the New Year?

In 2021, the Department of Health and Human Services (HHS) proposed changes to the Privacy Rule under the Health Insurance Portability and Accessibility Act of 1996 (HIPAA) that would significantly alter the current regulations...

Blog

The Donation Sweepstakes

Tis the season. Some people like to use the phrase “Doing Well by Doing Good.” Early U.S. business magnates knew that financial benefits can come from philanthropy. In 1888, Cornealius Vanderbilt donated $250,000 (that’s...

Matter

Successful Representation of Insurer before U.S. District Court for the District of Maine

Verrill successfully represented an insurer before the U.S. District Court for the District of Maine in an insurance coverage matter alleging that the insurer improperly denied a defense and indemnification to a landlord under...

Publication/Podcast

Determining Whether Your Entity is a Reporting Company: Selected Issues

Under the Corporate Transparency Act ( CTA ), more than 30 million “ Reporting Companies ” will need to register with FinCEN (a bureau of the U.S. Treasury Department) and file Beneficial Ownership Information...

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

HR Power Hour with Heather Hansen

News

Expanded 2024 Maine Diversity Summer Associate Program Now Accepting Applications

Event

Annual Employment Law Update

More details coming soon!

Publication/Podcast

Corporate Transparency Act—Considerations Affecting Entities That Are Exempt or Excluded from Reporting Company Status

The Corporate Transparency Act ( CTA ) takes effect starting January 1, 2024. The Act is administered by FinCEN , a bureau of U.S. Treasury charged with combatting money laundering and other financial crimes...

News

Verrill Recognized Nationally for Health Care, Land Use and Zoning, Commercial Litigation, Real Estate, and Trust & Estates by Best Lawyers®

Contact Verrill at (855) 307 0700