Peter S. Reichertz is Of Counsel in the Washington D.C. office, and is leader of the firm’s Food and Drug Law Group. Mr. Reichertz concentrates in both food and drug regulatory law and intellectual property law. He counsels companies whose products are regulated by the FDA under the Federal Food Drug and Cosmetic Act.
He represents manufacturers and distributors in obtaining approval to market drugs, medical devices, food, dietary supplements and cosmetic products, and counsels on all aspects of marketing of such products, including providing advice on labeling, advertising, manufacturing and distribution issues. He negotiates and prepares clinical trial, distribution, supply, contract manufacturing and quality agreements. He also counsels on related federal and state regulatory statutes.
Mr. Reichertz’s practice also includes advising advertising agencies, clinical investigators, research organizations and other non-manufacturers on compliance with the Federal Food Drug and Cosmetic Act. He represents clients in FDA rulemaking proceedings, and in enforcement proceedings brought by the U.S. on behalf of the FDA.
Mr. Reichertz also represents clients in advertising disputes related to FDA-regulated products, both at the FDA and in false advertising litigation under Section 43(a) of the Lanham Act and before the National Advertising Division of the Better Business Bureau.
In addition, Mr. Reichertz practices in intellectual property, specifically in trademarks, copyrights, trade secrets and licensing. His trademark expertise includes counseling and advising clients on the selection and adoption of trademarks, as well as the prosecution of trademark applications in the United States Patent and Trademark Office. He also prepares and negotiates trademark licensing agreements.
- J.D., The National Law Center, George Washington University, with honors
- A.B., Brown University
- District of Columbia
- U.S. Supreme Court
- U.S. Court of Appeals for the Federal Circuit
- U.S. Court of International Trade
- Representing clients in purchase and sale of FDA-regulated companies and products. Some recent transactions include:
- Represented Luitpold Pharmaceuticals, Inc. in connection with its acquisition of Roxro Pharma, Inc.
- Represented C.B. Fleet Co., Inc. in connection with the sale of a gastrointestinal pharmaceutical product, under development, to a private-equity backed portfolio company.
- Represented Luitpold Pharmaceuticals, Inc. in connection with its acquisition of all of the stock of PharmaForce, Inc.
- Representation of U.S. pharmaceutical company in connection with its acquisition of gastro-intestinal care products.
- Representation of Luitpold Pharmaceuticals, Inc. in connection with its acquisition of the dental business of BioMimetic Therapeutics, Inc.
- Preparation of numerous distribution and licensing agreements involving FDA-regulated products, and advising clients on FDA and other regulatory concerns regarding same.
- Preparing, filling and obtaining acceptance of 510(k) notifications for a variety of device products, for new uses and changes to products.
- Reviewing ANDA’s and NDA’s prior to submission, preparation of the administrative documents as part of the the ANDA and the NDA, and advising clients on issues relating to priority review and filing issues.
- Advising clients on acceptable off-label promotional activities and review of advertising for compliance with FDA and FTC requirements.
- Prosecution and defense of false advertising claims in the federal courts and before the NAD involving drugs, cosmetics and dietary supplements, and advice to clients to minimize risk of advertising challenges.
- Representing clients importing products with Notices of Detention relating to registration and labeling issues.
- Member, American Bar Association
- Member, International Trademark Association
- Member, NGLBT Association
- Member, National Leadership Council, Lambda Legal
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