Life Sciences - Regulatory & Public Policy

Overview

The life sciences industry is one of the most highly regulated and companies are confronted by enormous pressures from both the government and regulatory authorities. Trying to keep up with the growing demands and complexity of government policies and legislation can open life sciences companies up to considerable risk.

Facing these challenges requires counsel who understand your business requirements and are able to recommend methods to mitigate your risks. We have deep experience providing regulatory counseling and advice on fraud and abuse, the Foreign Corrupt Practices Act (“FCPA”), compliance audits, reimbursement issues, due diligence, and more.

We also understand the interplay between law and politics, and our experienced team of lobbying and communications professionals can help you position your company in front of Congress and regulatory agencies to help you achieve your objectives. Further, because of the breadth of our services, we can help you address multiple facets of each regulatory issue, such as internal investigations, data privacy, government affairs, and litigation.

How We Can Help

Regulatory

Drawing on our government and life sciences industry experience, our team provides a wide range of compliance counsel and enforcement representation to life sciences companies, including:

  • analyzing, counseling, and structuring arrangements for compliance with fraud and abuse laws, including state and federal anti-kickback laws, civil monetary penalties law, physician self-referral laws, false claims acts, and related state licensure and unprofessional conduct regulations
  • conducting compliance audits and internal investigations, and advising on obligations under federal and state marketing and disclosure laws, including the Federal Open Payments program (“Sunshine Laws”)
  • global data protection compliance counseling, including advising on strategies for the management and sharing of both data and human biological samples
  • analyzing and reviewing proposed transactions for federal and state registration, licensure, and/or accreditation impact

We also provide comprehensive advice on FDA approval and compliance matters, including conducting regulatory due diligence reviews to identify and assess risks associated with target companies.

Compliance and Anti-Corruption

We have significant experience advising life sciences companies on FCPA issues, the UK Bribery Act (“UKBA”), and other anti-corruption laws. We are knowledgeable in all aspects of FCPA enforcement and compliance, and have conducted internal investigations in most parts of the world. Our substantive experience extends to:

  • compliance
  • due diligence
  • counseling
  • investigations
  • representation before the DOJ and SEC

Government Relations

Our government affairs affiliate, Blank Rome Government Relations LLC, is comprised of top lobbying and strategic communications professionals with first-hand knowledge of the legislative and administrative processes in D.C. and in state and local governments. Our government relations professionals help life sciences clients develop focused, successful strategies to help navigate the complex issues that cut across all branches of government, including:

  • research
  • FDA approval
  • reimbursement and payment
  • registries
  • quality measurement
  • Sunshine Act disclosures
  • trade and tax issues

What Sets Us Apart

  • We add value for our clients by leveraging relationships within the life sciences and financial industries, as well as the government, to facilitate key introductions that create business opportunities and solve problems.
  • Our life sciences industry team is bolstered by a deep bench of recognized intellectual property leaders with significant experience in acquiring, defending, enforcing, and invalidating medical device and pharmaceutical patents.
  • We have achieved numerous wins in high-profile life science disputes and have extensive trial and appellate experience in federal and state courts across the country.
  • We advise on compliance strategies with respect to global data protection laws and the processing of human biological samples, including transparency initiatives in clinical research.

Experience

Regulatory Compliance

  • Advised and counseled a global pharmaceutical and health products company, including many of its operating companies, in comprehensive compliance matters.
  • Provided a major international pharmaceutical company FCPA advice and conducted internal investigations into allegations of FCPA violations in Asia, South America, and Europe.
  • Represented an international medical device company in fraud and abuse analysis and policies and procedures, privacy compliance advice, and other compliance advice.
  • Represented a biochemical company in an FCPA matter that resulted in a non-prosecution agreement, combined fine, and disgorgement payment less than the amount the company had reserved, and no compliance monitor.

Government Relations

  • Advocated on behalf of a national trade association for medical device companies on issues relating to research, FDA approval and process, reimbursement and payment, registries, quality measurement, Sunshine Act disclosures, and trade and tax issues.
  • Represented a national trade association of distributors of medical supplies, pharmaceuticals, devices, and other health care equipment, on payment, supply chain, tax, and many other policy issues.
  • Represented a large generic drug manufacturer on matters specific to their drugs as well as policy issues including:
    • AIDS in Africa policy
    • EpiPen issues in schools
    • reimbursement and tax issues
    • clinical issues