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

Matter

FDA Advertising/Promotion

Presented to senior executives and other management of a start-up pharmaceutical company on complying with U.S. Department of Food and Drug Administration (FDA) advertising and promotion requirements pre- and post-launch.

Publication/Podcast

FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19

Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines...

Matter

On-Site Counsel

Served as on-site, long-term legal counsel for various pharmaceutical and device companies during times of staffing shortage at the companies.

Publication/Podcast

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to...

Publication/Podcast

FDA Announces New Updates to its Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App

On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “ Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency ” with new information...

Matter

European Union GDPR—Pharmaceutical Company

Advised pharmaceutical company on all aspects of compliance with the European Union General Data Protection Regulation (GDPR), including gap analysis, policy and procedure development, and vendor and other third party contract revisions.

Matter

Informed Consent Form Templates

Developed 23 different types of global research informed consent templates for a major pharmaceutical company along with detailed negotiation guidelines for compliance with applicable laws and best practices.

Publication/Podcast

COVID-19 Expanded Access Template

We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements...

Publication/Podcast

Proposed Regulations Under the CCPA Provide Some Clarity, But Questions Remain

Earlier this month, the California Attorney General issued long-awaited proposed regulations (“Proposed Rule”) under the California Consumer Privacy Act (“CCPA”) [1] along with a Notice of Proposed Rulemaking Action and Initial Statement of Reasons...

Matter

CAN-SPAM/E-Sign Act

Acted as the go-to advisor for a pharmaceutical company for advice on CAN-SPAM and E-Sign Act.