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 taskforce and is a Special Government Employee (SGE) consultant to the FDA’s Risk Communications Advisory Committee. He is also a 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.
A recent recommendation by the U.S. Copyright Office allowing for the bypassing of technological protection measures (TPMs) in medical devices for purposes of repair, maintenance and service has been adopted and immediately put into effect. This is bad news for patient safety. At a time when we’re loudly and publicly debating the relative merits of the Build Back Better Act, the U.S. Copyright Office’s announcement, deep inside the Federal Register and written in very user unfriendly dense government jargon, landed not with a bang, but with a whimper. On purpose. Hiding in plain sight. This terrible ruling offered without a comment period or any other appeals mechanism, will have a profoundly negative impact on America’s public health.
India and South Africa recently urged the World Trade Organization to suspend intellectual property protections for COVID-19 vaccines and treatments. The claim is that this would allow developing countries to manufacture “cheap” COVID-19 therapeutics and vaccines, hastening the end to the pandemic—at least, that’s what proponents claim. They’re wrong. Dangerously wrong. Gutting IP protections won’t make COVID-19 medications more readily available but it will set a terrible precedent that will chill future medical innovation.