Event Detail

Womble Carlyle member and former Maryland Governor Robert L. Ehrlich, Jr. this week moderated a major life sciences debate in the nation's capital. Hosted by the U.S. Chamber of Commerce, the debate centered on legislation in the U.S. Congress to establish a regulatory pathway for follow-on, or "generic," biologic medicines.

Governor Ehrlich, who served as Co-Chair of the House Biotechnology Caucus in Congress, moderated a panel of experts that included David Beier, Director of Global Government Affairs at Amgen; Dr. Adrian Thomas, Director of Risk Management at Johnson & Johnson; Nancy Taylor, life sciences attorney at Greenburg Traurig; and Dr. William Schweitermann, a biotechnology consultant previously with the U.S. Food and Drug Administration. In addition, Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA), two leaders in the debate over follow-on biologics legislation, offered their views on competing proposals in Congress and the likelihood of a final agreement.

Mr. Beier and Dr. Thomas argued that creating a pathway for generic biologics would lead to weaker patient safety standards. They also argued that a pathway would reduce incentive for innovative companies to research and develop new biologic drugs.

Ms. Taylor and Dr. Schweitermann argued that creating a regulatory pathway for follow-on biologics would not jeopardize patient safety and would lower health care costs for patients, employers, and insurers, and others.

"This forum demonstrates the high stakes surrounding life sciences policy, particularly as it relates to intellectual property and patent litigation," said Governor Ehrlich. "I was honored to represent Womble Carlyle at such an informative discussion. With its extraordinary industry knowledge and experience, Womble Carlyle's Life Sciences Industry Group is well positioned to help clients succeed in such a highly regulated and competitive marketplace."