Irving L. Wiesen, Esq.
Irving L. Wiesen, Esq. has had over thirty years experience in the food and drug industry representing a broad spectrum of brand name and generic pharmaceutical and medical device clients, both domestic and international. Prior to setting up his current FDA legal practice, Mr. Wiesen was a partner at Bass & Ullman, a well-known pioneering food and drug law firm as well as Division Counsel of Boehringer Ingelheim Pharmaceuticals Inc., a multi-national pharmaceutical company. Mr. Wiesen has appeared in court and in many other federal and state administrative and international forums on behalf of his clients and has scored many notable successes on their behalf. The firm has extensive contacts throughout the industry, including at the FDA. Mr. Wiesen has lectured and published extensively on matters related to food and drug law and the pharmaceutical industry.
Bass & Ullman, P.C., New York, New York
PARTNER (1992-95), ASSOCIATE (1980-86)
Represented pharmaceutical, dietary supplement, foods, device and bulk drug companies in FDA regulatory compliance matters and federal and state litigation. Responsibilities included the full range of FDA requirements for pharmaceuticals, foods, and devices, GMP compliance, Application Integrity Policy, FDA petitions and comments on proposed regulations; FDA inspections; counsel on pharmaceutical and device development, testing, application and marketing; advertising and labeling of pharmaceuticals and foods, successfully represented companies in adding drugs to state formularies.
National Association of Pharmaceutical Manufacturers
COUNSEL, TECHNICAL COMMITTEE (1992-95)
Counsel to the National Association of Pharmaceutical Manufacturers on FDA technical and policy issues; worked with FDA on drug policy issues including proposed regulations, GMP’s, testing standards, patents and exclusivities; provided comments on proposed FDA regulations, served on committees with FDA personnel to develop regulations and policies affecting the pharmaceutical industry.
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
DIVISION COUNSEL (1989-92), ATTORNEY(1986-89)
FDA, DEA, FTC regulatory counsel, including primary responsibility for all labeling, advertising review and marketing programs for human and veterinary pharmaceuticals; responsible for all aspects of FDA compliance; primary legal counsel and liaison with marketing, drug regulatory affairs and scientific affairs on all drug education and marketing initiatives; negotiated and drafted contracts including research and product development, licensing, manufacturing, and distribution; included a broad range of legal work, including negotiating joint ventures, and drafting commercial agreements, antitrust counseling, personnel law counseling, and general legal counseling. Successfully represented world-wide Boehringer Ingelheim before the World Health Organization to prevent scheduling of its major antihypertensive drug; successfully made the company's case to the FDA for statutory exclusivity for an antiplatelet drug; litigation support including general commercial, federal and state administrative hearings, trademarks and unfair competition, labor relations.
• New York State
• State of New Jersey
• United States District Court for
the Southern and Eastern
Districts of New York;
• United States Court of Appeals
for the Federal Circuit.
New York University School of Law, J.D. 1980
Journal of International Law and Politics, Articles Editor
Columbia University School of Arts & Sciences, M.A. English Literature 1977
Yeshiva University, B.A. 1976, Cum Laude
CTSW negotiates, drafts and provides practical legal and business advice on joint venture and strategic alliances, technology licensing and development agreements, shareholder agreements, research agreements, employment agreements consulting and confidentiality agreements, public and private financing, business plans and private offering memorandums, and mergers and acquisitions. Solid network of industry contacts, including specialists, investment bankers, strategic industry players and venture capitalists.
Specializes in food, drug, and cosmetic law and also provides legal services to its clients in many other areas, including litigation support and trademark / copyright matters. The partners of the firm were all formerly with Bass & Ullman, a firm which had established a nationwide reputation in the areas of food and drug, intellectual property and trade regulation litigation. Ullman, Shapiro & Ullman firm members are called upon as expert lecturers on these subjects. The firm's clients include vitamin, food supplement, herbal and health food manufacturers and distributors; cosmetic marketers and manufacturers; and advertising agencies servicing these areas.