Accurate genetic testing stands to transform modern medicine by offering effective, personalized treatment. Last week, the U.S. Food and Drug Administration (FDA) authorized marketing of the first direct-to-consumer (DTC) genetic health risk (GHR) tests. Individuals in the US can now purchase DTC tests and gain potentially useful information on their genetic predisposition to 10 diseases […]
Although the federal Tobacco Control Act gives the U.S. Food and Drug Agency extensive authorities to regulate tobacco products and their marketing, labeling, and sale, the Trump Administration’s new pro-business, anti-regulation approach might put some serious obstacles in the way of any significant new FDA regulations to reduce the massive amounts of tobacco use and […]
In an international game of Whac-A-Mol, this week China announced that it would be adding four lethal heroin-like narcotics to a list of controlled substances to help combat the growing opioid epidemic in America. The primary target of the ban is Carfentanil, one of the latest and deadliest synthetic opioids to show up in the […]
On December 13th, President Obama signed the 21st Century Cures Act into law. This law provides $6.3 billion for cancer cure research, and to address the growing opioid drug abuse epidemic. The Act also allows for a more streamlined approval process for the FDA to bring new drugs and medical devices to the market. While […]
This week the pharmaceutical pricing discussion centers on Mylan, and its 548% boost in the price of EpiPens. The press coverage and industry promises are a familiar scene: a large drug company buys a well-established medication or technology, and then raises the price. There is outrage, there are statements of promises and remedies, and then […]
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.