Irving L. Wiesen, Esq.

Irving L. Wiesen, Esq. has had forty 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 internationally 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.