By Jorge González-Gallarza Hernández, courtesy of the Mercatus Center As states and hospitals scour the world for urgently needed COVID-19 supplies, Food and Drug Administration (FDA) efforts to increase the importation of face masks, protective shields, and other products have come into conflict with the agency’s mandate to ensure that all medical devices entering […]
Tag: FDA
COVID-19 triggered “cascading structural failures”
By Martin Gurri, courtesy of the Mercatus Center Like most people I know, I am presently trapped in social isolation, stuck in a dreamlike parenthesis between what was once normal life and the uncertain struggles lurking on the other side. We are huddled, most of us—the fortunate ones—in our hiding places, waiting. That […]
Coronavirus vaccine? Not so fast
“Optimism About a Speedy Coronavirus Vaccine Is Misplaced” By Henry I. Miller, courtesy of the Mercatus Center As the outbreak of the novel coronavirus continues to gain momentum in the United States, there is intense interest in the development of a vaccine. Several US drugmakers have begun working on a vaccine, independently […]
Freed from regulatory shackles, drug firms step up on COVID-19 testing
“Temporarily Unshackled Private Sector Responds to Demand for More Coronavirus Tests” By Jeffrey Singer, courtesy of the Cato Institute I and others have attributed much of the initially flat‐footed response of public health officials to the coronavirus pandemic to cumbersome, inflexible, and outdated regulations controlling the development and distribution of drugs and tests. As I pointed […]
Washington Beyond The Headlines: New Trade Deals Will Bolster Strong U.S. Economy
By Andy Blom, TES Washington Editor January 16, 2020 A BIG week in Washington! Impeachment staggers forward as the House finally sends articles of impeachment to the Senate. Of course, this is the government at work, so it’s all about process and now this will drag on for an indeterminate amount of time. […]
Analyzing health records, insurance claims speeds new treatments
Historically the trove of medical and para-medical information known as “real-world evidence,” including health records but also insurance claims and patient registries, has mostly been used as a source for additional evaluation of the efficacy of existing drugs after they have already been approved. But […]
Thakur: Are Generic Drug Safe?
In an op-ed in the The Hill, Dinesh Thakur, Founder of Medassure Global Compliance Corporation, reveals just how little we know about the provenance of generic medicines. Approximately 80% of America’s drug supply has “significant components” that were manufactured overseas, according to the Pew Prescription Project. “Lack-of-effect” results — when patients don’t […]
“We are clearly moving away from an evidence-based approach to regulation.”
By Erik Sass TES Editor One of the more confounding mysteries of U.S. public health regulation in recent years has been the crackdown on new forms of nicotine delivery, including e-cigarettes and vaping. On the face of it these new technologies, though still bad for human health, are vastly preferable to regular cigarettes, […]