HPM partner McNamara dies: Stephen H. McNamara, a partner in the Hyman, Phelps & McNamara law firm and a congressional advisor on the Dietary Supplement Health and Education Act, died Dec. 28 of complications from cancer at the age of 66. McNamara's wife Caroline, children Matthew and Deborah and six grandchildren survive him. He was a member of HPM from 1984 until poor health forced his withdrawal from practice in 2003. He advised Congress in the development of DSHEA, which passed in 1994. Prior to joining HPM, McNamara was senior vice president and general counsel for the Cosmetic, Toiletry and Fragrance Association (now the Personal Care Products Council). He also was a staff attorney at FDA, a senior trial attorney and the associate chief counsel for food. He served as acting chief counsel for about a year and was twice given the FDA Award of Merit, the agency's highest service award. McNamara served as a chaplain's assistant in the U.S. Army from 1967-1969, and was awarded the Bronze Star, the Purple Heart and the Army Commendation Medal
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
