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Executive Summary

FDA's NEW CHIEF COUNSEL MARGARET JANE PORTER is a 12-year veteran of the HHS General Counsel staff but does not have specific experience with the FD&C Act. Since 1986, Porter has been the deputy chief counsel at the Social Security Administration with responsibility for the Social Security Programs. She has also has spent seven years with the Health Care Financing Administration. Among her projects at HCFA, she concentrated on the development of dialysis payment regulations. Porter, 42, was introduced to the FDA legal staff on the evening of Oct. 3. She will start into the job on October 23. While she does not have any clear ties to the current FDA staff or the issues of FDA legal department, she does have contacts in the FD&C bar. One of her associates at HHS, for example, was Terry Coleman (Fox, Weinberg and Bennett). Coleman was on the FDA legal staff in the 1970's. A Harvard Law graduate, cum laude, of 1977, Porter also has earned two masters degrees from the University of Illinois, in Russian history and in library science. She was a special recruit in the Library of Congress from 1971-1974. She obtained her B.A. in modern languages from Colorado State University in 1969. Porter's background with the HHS General Counsel should help to quiet the tensions between the department and FDA's legal staff. The FDA chief counsel's office has been hurt be the sense of a loss of autonomy in the wake of the HHS Inspector General's involvement in the oversight of the ANDA and NDA review processes. The issue of FDA autonomy was one of the key elements in the departure of previous FDA chief counsel Thomas Scarlett. A career FDA and FD&C Act lawyer, Scarlett attempted to protect information collected by FDA under the FD&C Act from potential outside release. As an outsider to the FDA community but an insider with HHS lawyers, Porter is not likely to face the same intra-department troubles. * A harbinger of a reconciliation between the IG's office and the FDA's chief counsel office was sent to the agency on Oct. 2. Inspector General Richard Kusserow issued a memo to HHS Chief Counsel Michael Astrue and FDA Commissioner Young more restrictively defining the IG's right to investigate into FDA matters. Kusserow specified four types of situations that the IG feels appropriate to step into: (1) false statements in applications to the agency; (2) counterfeit drugs; (3) the sale of illegal anabolic steroids; and (4) diversion of samples. The IG also maintains responsibility for investigating fraud be FDA employees. * Former FDA chief counsel Scarlett has been interviewing with a number of Washington law firms and said he does not expect to make a career decision for at least "several weeks." He reportedly has been interested in the smaller FDA-specialty firms. Between stints with FDA, he was with Morgan, Lewis & Bockius. FDA CHIEF COUNSEL MARGARET PORTER EXPERIENCE 1986-present: Deputy Chief Counsel for Social Security Programs, Social Security Division, Office of the General Counsel, HHS. 1983-86: Supplemental Security Income Branch Chief, Social Security Division, Office of the General Counsel, HHS. 1977-83: Staff Attorney, Health Care Financing & Human Development Services Division, Office of the General Counsel, HHS. 1971-74: Administrative and Editorial Assistant, Government Document Cataloger, Special Recruit, Library of Congress. EDUCATION 1977: Harvard Law School, JD, cum laude 1973: U. Illinois, MA, Russian History 1970: U. Illinois, MA, Library Science 1969: Colorado State U., BA, Modern Languages HONORS AND MEMBERSHIPS Office of the General Counsel Exceptional Service Award, 1988 HCFA Administrator's Citation, 1981 Federal Bar Association; Washington Ethical Society

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