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Peter J. Pitts

President

Center for Medicine in the Public Interest

Peter Pitts is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine. A former member of the United States Senior Executive Service, Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA’s Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug task force and is a Special Government Employee (SGE) consultant to the FDA’s Risk Communications Advisory Committee. He is also an Adjunct Scholar at the Washington Policy Center.

Specific areas of global policy expertise include FDA policy and process, healthcare technology assessment and reimbursement issues, biosimilar development, Rx-to-OTC switching, risk management plans, GMP policies, pharmacy education programs, drug safety, DTC/ItP, Critical Path, personalized medicine, clinical trial transparency, IP protection, FDA reform, drug importation, counterfeiting, genetically modified food issues, food safety and security, recalls, nutritional labeling.

Recent Articles by Peter J. Pitts

Is the Food and Drug Administration Killing Chevron Deference?

The U.S. Supreme Court on Friday added another case to its docket that challenges the Chevron Doctrine, a decades-old principle instructing lower courts to defer to federal agencies’ interpretations of ambiguous laws. The Court said it will hear Relentless, Inc. v. Dept. of Commerce in tandem with an almost identical appeal brought by Rhode Island herring fishers. Mark your bingo card if you had “Rhode Island herring fishers.”

The Fatal Attraction of Medical Device ‘Right to Repair’

The contentious issues surrounding Right to Repair are getting super-heated as the U.S. Copyright Office concludes its triennial rulemaking review of exemptions to section 1201 of the Digital Millennium Copyright Act (DMCA). Exemptions granted would be in force for three years beginning October 2024.  When is an exemption not an exemption? When it’s an exemption from common sense.