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1993 FDLI Update 1 (1993)

handle is hein.journals/fdliup1993 and id is 1 raw text is: The Food and Drug Law Institute UPDA E Promoting an understanding of the laws and regulations administered by FDA 1993 Number 1 Above: Peter Barton Hutt, Covington & Iurling, explains the evolution oftheAgency attendees. Below: Ronald Chesemore, DA, indicates regional and district locations across the U.S. Route to: Q Q Q. Hill And FDA Meet To Discuss Constituent Questions: Advice Applicable To Industry On March 12th, senior FDA officials explained the Agency, its structure, functions and resources to Hill health legislative affairs staffers. Gathering in a hearing room on Capitol Hill, staff from both the Senate and House of Representatives heard top FDA officials offer advice on how to work with FDA to answer constituent inquiries. The meeting was developed and chaired by Patrick McLain, Senior Vice President of Rowan and Blewitt and Kay Holcombe, former Deputy Associate Commissioner for Legislative Affairs, FDA, who is now a professional staff member on the Energy and Commerce Committee. Relevant experience was shared by Nancy Taylor, Esq., veteran Hill staffer of ten years, currently with The Law Offices of Deborah Steelman. Ms. Taylor suggested that using a checklist of do's and don'ts for handling inquiries was an effective practice. This checklist is also helpful to companies in assessing if their problem can be solved before contacting a representative on Capitol Hill. According to Ms. Taylor, 1 o there are seven considerations that the Hill staff must review when handling a constituent question. She advised that it is important to 1) understand where the burden of proof lies, either with the company, the Agency or another party; 2) determine exactly who has the outstanding issue and where the issue has been left - does the burden lie with the Agency or the company; 3) recognize if the particular issue is in litigation (then there should be no Hill involvement); 4) recognize if the issue in dispute is a matter of science or procedure; 5) learn if there is pending legislation or regulation; 6) understand why the constituent is seeking Hill assistance and be sure that no competitive advantages are made; and lastly 7) know who to call and when with regard to FDA, outside counsel, or another staff member. An expert panel of FDA representatives assembled to share insight and provide specific descriptions of their roles and responsibilities in the regulatory system. David G. Adams, Esq., FDA's Director of the Policy Development Coordination Staff, explained legal issues the Hill staff may encounter in the coming year such as enforcement legislation, civil money penalty authority, regulation of dietary supplements, regulating tissue transplants and orphan drugs. He also outlined some possible future issues or controversies including user fees, food safety, drug pricing and comparative assessments of therapeutic alternatives. Continued on page 7 In This Issue Calendar of Events 2 New Members 4 Recommended Publications 6 Contributing Member Article 7 Food and Drug Law Journal 8 Food and Drug Law Reports 9 People On The Move 10 Job Exchange 11 Digitized from Best Copy Available

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