Regulatory LIFE SCIENCES

Our lawyers have experience spanning all of the regulatory needs of our life sciences clients.


A hallmark capability of our firm is our strength in representing clients in dealings with the United States and other governments. We apply these skills in key ways in our life sciences practices. We regularly counsel clients in handling issues related to the Food and Drug Administration (FDA), merger clearance matters, consortia issues and other antitrust concerns, as well as issues relating to public policy and strategy.

Experience

Some of of the regulatory needs our life sciences clients must face fall into the following key areas:

FDA

We support life sciences companies on a wide array of regulatory matters, including issues before the FDA and other agencies. For instance, we advised a client during negotiations and Congressional passage of landmark FDA reform legislation. We also counsel life sciences clients based outside of the United States on FDA regulatory issues and related matters.

Antitrust and Competition

Our preeminent Washington- and Brussels-based antitrust and competition group counsels our life sciences clients on merger clearance matters, consortia issues and enforcement actions by United States and European Union (EU) regulatory authorities. For example, we have long represented the SNP Consortium and also are providing antitrust advice to a group of major research-based pharmaceutical manufacturers who are engaged in joint research and development of AIDS-related drugs. Our Brussels team is highly sophisticated in advising on the often overlooked and complex issues in connection with structuring licensing and distribution arrangement to comply with the applicable EU block exemptions.

Public Policy and Strategy

Drawing upon our lawyers in Washington familiar with public policy, we have advised pharmaceutical companies and trade associations on a number of issues facing the pharmaceutical industry today, and developed strategies with our clients to address these issues. For instance:

  • We advise major pharmaceutical companies on the range of regulatory challenges faced by the industry and actions they might take to address those challenges
  • We counsel a pharmaceutical trade association on state and local legislative initiatives that would affect the pricing of pharmaceuticals
  • We act as outside counsel to a number of pharmaceutical companies on issues relating to enforcement
  • We advise a pharmaceutical trade association on proposed legislation that would affect patent protection for pharmaceuticals

Publications & News

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March 16, 2018

WilmerHale Recognized for Outstanding International Lawyers and Practices in Chambers Global 2018

In the 2018 edition of Chambers Global, 33 WilmerHale lawyers were named among “The World's Leading Lawyers for Business."

November 7, 2017

LMG Life Sciences 2017 Honors WilmerHale With Top Rankings

LMG Life Sciences has recognized WilmerHale among the nation's leading life sciences law firms in its 2017 rankings, citing the firm's Life Sciences Practice as “renowned for its range and multidisciplinary teams that counsel clients in technology, pharmaceutical and medical device companies as well as investment banks and venture capitalists.”

May 26, 2017

WilmerHale Lawyers and Practices Recognized in 2017 Edition of Chambers USA

Chambers and Partners announced its rankings for the 2017 edition of Chambers USA: America's Leading Lawyers for Business, with WilmerHale listed among the nation's best in 50 practice area categories. Chambers also ranked 86 WilmerHale lawyers as leaders in their respective fields.

May 18, 2017

Nations Press for International Restrictions to Govern Genetic Sequence Data

As various nations consider application of international ABS requirements to GSD, research organizations and synthetic biology companies should closely follow these developments to determine how they may impact their use of GSD. Moreover, those accessing GSD should consider, if possible, the extent to which unilateral ABS agreements requirements may govern their use of such information.

May 17, 2017

WilmerHale Ranks Among Top Three Life Sciences Law Firms for Second Consecutive Year

The index—launched last year by Lake Whillans and Breaking Media (publisher of MedCity News and Above the Law)—identifies which law firms are the most active and relevant for life sciences companies.

March 21, 2017

WilmerHale Recognized for Outstanding International Lawyers and Practices in Chambers Global 2017

Chambers Global has named 27 WilmerHale lawyers among "The World's Leading Lawyers for Business" in its 2017 edition.

December 9, 2016

WilmerHale Listed Among Top Thought Leaders in Life Sciences Law Firm Index

Lake Whillans evaluated firms based on the strength of elements such as white papers, contributions to third-party media and speaking engagements.

November 9, 2016

LMG Life Sciences Ranks WilmerHale and Attorneys Among the Best

The 2016 guide highlights nine firm practices and 18 attorneys, recognizing work under three categories—Intellectual Property, Finance and Transactional, and Non-IP Litigation and Enforcement.

May 27, 2016

WilmerHale Lawyers and Practices Recognized in 2016 Edition of Chambers USA

Chambers USA: America's Leading Lawyers for Business announced its final rankings for the 2016 edition, with WilmerHale ranking among the nation's best in 47 practice area categories. Chambers also ranked 82 WilmerHale lawyers as leaders in their respective fields.

January 12, 2016

WilmerHale Named Among Top Three Life Sciences Law Firms

WilmerHale has been named among the top three Best Life Sciences Law Firms for 2016 in the inaugural Life Science Index.