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Bruce S. Manheim, Jr.
Partner
Ropes & Gray
One Metro Center
700 12th Street, NW, Suite 900
Washington, DC 20005-3948
T + 1-202-508-4696
F + 1-202-383-8332
+ 1-202-508-4607 secretary
E-mail
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Practice
Bruce Manheim is a partner in the Washington, D.C. office of Ropes & Gray. Bruce's practice focuses on the complex scientific and legal questions that arise from the laws and regulations that govern the life sciences and medical device industry. Bruce is also actively involved in pro bono matters and serves on the firm's Pro Bono Committee.
Professional Experience
Bruce brings a highly focused scientific and public policy background to the firm. He spent several years studying biology at Cornell University and the University of Malaya in Kuala Lumpur. He then worked for more than a decade as a senior scientist-attorney for the Environmental Defense Fund (EDF) where he focused on numerous environmental and public health matters, including global climate change and the development of medicinal products from biodiversity. While at EDF, he testified numerous times before Congress and served on U.S. delegations to international treaty meetings.
Since entering private practice, Bruce has regularly counseled clients on the panoply of legislative and regulatory issues confronting pharmaceutical and biotech companies. He has prepared and submitted citizen petitions to FDA on issues ranging from tobacco control to Hatch-Waxman exclusivity, reviewed legislative initiatives affecting clients, undertaken regulatory due diligence in connection with transactions involving life sciences companies, and assisted the firm's government enforcement lawyers in investigations of the marketing of pharmaceuticals and medical devices.
In addition to helping clients address regulatory issues, Bruce has litigated cases that involved challenges to federal agency decisions under the Administrative Procedure Act. Many of these cases involved requests for preliminary injunctive relief in which the client sought to stay the decision of a federal agency allowing for certain actions. See, e.g., Environmental Defense Fund v. Massey (extraterritorial application of U.S. law); Serono Laboratories v. Shalala (standards governing approval of generic drugs); and Brady Campaign Against Gun Violence v. Kempthorne (allowing loaded guns in parks).
While much of his work has involved a broad array of products, Bruce has also spent more than a decade on two major public health problems -- tobacco addiction and obesity/overweight. He has assisted in efforts to switch smoking cessation and weight loss pharmaceuticals from prescription to over-the-counter status. He has also pursued efforts at FDA and state levels of government to ban or control the marketing of fraudulent products, including certain dietary supplements, which may divert consumers from their efforts to quit smoking or lose weight.
Finally, Bruce is recognized as one of the leading experts on the issue of follow-on biologics (FOBs). He has counseled clients on legislation that would allow for approval of FOBs, submitted regulatory filings to FDA on the issue, spoken numerous times about the subject, and published one of the key articles on the implications of approving FOBs. That article is routinely relied upon and cited by those involved in the debate ('Follow-On Biologics': Ensuring Continued Innovation in the Biotechnology Industry, Health Affairs 25(2) (2006)).
Bar Admissions
- Washington, D.C., 1989
- California, 1988
Education
- 1988,
J.D., cum laude, Georgetown University Law Center
- 1981,
M.S.L. (Public Policy), cum laude, Vermont Law School
- 1978,
M.A. (Biology), cum laude, Claremont Graduate University
- 1977,
B.A. (Biology), cum laude, Pomona College; Phi Beta Kappa
©2009 Ropes & Gray LLP. All rights reserved.
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