KKB’s history dates from 1953, when the firm’s founder, Vincent A. Kleinfeld, began his private practice.

Mr. Kleinfeld was one of the first lawyers to devote his practice to “FDA law.” He began his career during the New Deal days in the Department of Justice, where for several years he headed a team of attorneys in charge of litigation under the then-new Federal Food, Drug, and Cosmetic Act of 1938. Later he served the Congress as counsel to the “Delaney Committee,” where he helped frame many of the important statutory concepts that were incorporated in amendments to the Act relating to pesticides, chemicals, and food additives. Mr. Kleinfeld’s wry and seasoned view of the world still provides useful guidance even after the passage of many years. For example, in 1967 he offered the following comment on the relationship between FDA and industry:

Mr. Kleinfeld was active in the firm until his death in 1993.

Mr. Kaplan began his career with the FDA chief counsel’s office and, in 1960, joined Mr. Kleinfeld in private practice, when the firm became known as Kleinfeld and Kaplan. During the course of his career, Mr. Kaplan represented clients in every aspect of FDA law, and was always involved in the most important FDA-related legal issues of the day. Mr. Kaplan was active in the firm until his death in August 2001.

Mr. Becker began his career, together with Mr. Kaplan, in the FDA chief counsel’s office. He left to join the legal department of Norwich Eaton Pharmaceuticals until, in 1969, he was lured back to Washington, DC, by Messrs. Kleinfeld and Kaplan. Since then, the firm has retained its present name. Mr. Becker retired in 1997.

In the years since 1953, we have been involved in a long series of fascinating and important legal issues. Here is a sample:

1958-1962		Passage of major amendments to the law regulating food additives, color additives, and the effectiveness of drugs.
Since 1962		Resolving the status of pre-1962 prescription drugs under the law.
Since 1972		Interpreting new rules for over-the-counter drugs under FDA’s monograph system.
Since 1976		Regulation of medical devices under new authorities granted to FDA.
Since 1984		Passage of major legislation permitting the wide use of generic drugs, and resolving ongoing issues raised by the legislation.
Since 1987		Working with food companies to implement health claims for foods and new labeling requirements.
Since 1994		Working with dietary supplement companies to implement the new regulatory status accorded to supplements.
Since 1997		Assisting clients in implementing new opportunities for drug marketing, drug exclusivity, medical device approval, approval of claims for foods, and other issues under the Food and Drug Administration Modernization Act.
Since 2002		Advising on new requirements under bioterrorism legislation.
		Responding to FDA anti-counterfeiting initiatives with respect to prescription drugs, advising companies that are victims of counterfeiters, defending a major combined FDA and FTC action against a dietary supplement manufacturer and distributor, and advising on HIPAA, drug reimportation, Medicare legislation, and internet pharmacy issues.