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Former FDA Associate Chief Counsel Joins FDA Practice

Patricia J. Kaeding's extensive FDA litigation and counseling experience expands growing practice area
March 04, 2004

The law firm of Godfrey & Kahn today announced the addition of Patricia J. Kaeding, former Associate Chief Counsel for the U.S. Food and Drug Administration (FDA), to the firm’s FDA practice. Kaeding has 10 years of litigation and counseling experience in the FDA’s Office of the Chief Counsel. She also will be a member of the firm’s litigation practice.

"At FDA, Patricia was widely respected for her versatility and ability to develop sophisticated responses in complex matters. Her broad range of experience will be extremely valuable in helping companies meet regulatory challenges, whether they involve bringing new products to market, maintaining or achieving compliance with regulatory requirements, or responding to an agency action. Her knowledge of decision-making, compliance, enforcement and litigation at FDA further strengthens our FDA practice, and provides valuable first-hand legal experience that will benefit our clients," said Rick Bliss, managing partner of Godfrey & Kahn.

Kaeding joined the FDA as Assistant Chief Counsel in 1993 and was promoted to Associate Chief Counsel in 1996. She has broad experience representing the FDA in federal court litigation involving all product areas, including the FDA’s authority over tobacco and a First Amendment challenge to a federal statute on drug compounding. Other issues she litigated at FDA include dietary supplements, qualified health claims, the line between health claims and drug claims, authority to seize food imports, advertising restrictions, intended use, combination products, restricted devices, device classifications, substantial equivalence determinations, preemption, pediatric testing of drugs, drug labeling, antibiotics, inspection warrants and authority, import procedures and lawsuits related to private tort litigation against drug and device companies. In addition, she counseled agency officials on program issues related to these litigation matters.

While at the FDA, Kaeding was responsible for providing advice on compliance and enforcement issues involving all product areas, as well as on import, export, and international issues. She was lead attorney on the implementation of the Export Reform and Enhancement Act of 1996, and served on working groups implementing the Public Health Security and Bioterrorism Preparedness Act of 2002. She has worked closely with other federal agencies, including the U.S. Customs Service, the U.S. Drug Enforcement Agency, the U.S. Department of Agriculture and the U.S. Department of Justice.

Prior to joining the FDA, Kaeding worked for the U.S. Department of Health & Human Services in the Office of the General Counsel in Chicago, Illinois. She received her Bachelor of Arts degree from the University of Wisconsin – Madison in 1989, where she graduated Phi Beta Kappa and received the prestigious College of Letters & Science Dean’s Prize. She received her law degree in 1992 from the University of Chicago Law School, where she was a member of the Law Review.

Godfrey & Kahn established its FDA consulting practice in November 2002, when former FDA regulator Morris Waxler, Ph.D. joined the firm. Waxler brought with him 26 years of FDA experience in regulatory procedures, documentation and decision-making. He has successfully formulated and implemented regulatory strategies for more than 60 manufacturers for a wide range of medical products.

"With Patricia Kaeding and Morris Waxler, we have a strong team of highly respected professionals with a broad range of FDA experience. To our knowledge, Godfrey & Kahn is the only Wisconsin law firm with a major FDA practice. With a growing number of Wisconsin-based companies involved in biomedical research, medical devices and other high-technology businesses, there is an expanding need for experienced FDA-related legal and consulting services. We look forward to helping businesses as they successfully develop and market the new products of the future," said Bliss.

Founded in 1957, Godfrey & Kahn has a statewide network of offices, including locations in Appleton, Green Bay, Madison, Waukesha and Milwaukee. With more than 175 attorneys, Godfrey & Kahn provides legal and business advice to clients ranging from small businesses and governmental entities to large privately and publicly held national and international companies.

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