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Category Archives: FDA

01.25.19

Develop your skills blending law, science, and policy as a Tobacco Regulatory Science Fellow at the U.S. Food and Drug Administration

By Darlene Huang

At my high school graduation, a friend and I had a short dialogue speaking to our graduating class about where our futures were headed. “What do you want to be when you grow up?” I asked her. She confidently answered, “A horse.” After an awkward moment or two went by, she continued with, “Or at […]

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12.11.18

Furthering Tobacco Control Requires a Broader Perspective

By Darlene Huang

Tobacco control efforts in the U.S. have predominantly been a state, local, and increasingly tribal endeavor with landmark federal reports and legislation spurring or guiding local actions. When I started in tobacco control at the local level in 2006, the CDC’s Best Practices for Comprehensive Tobacco Control Programs was our roadmap. It focused our efforts […]

08.17.17

Is There Any Reason to Allow Cigarette Companies to Send Coupons (or Any Other Advertising) to Nonsmokers?

By Eric Lindblom

  A recent study in the Nicotine & Tobacco Research journal confirms that the tobacco industry sends discount cigarette coupons to non-smokers in the USA and that some of those receiving the coupons become smokers. The study concludes that its findings support more restrictive policies to curtail the use of tobacco product discount coupons because […]

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05.05.17

Louisiana Proposes that the Federal Government Bypass Patent Restrictions to Acquire Cheaper Hepatitis C Drugs

By Sonia Canzater

Anyone who follows U.S. public health issues – or who reads my blog posts – knows that the cost of the drugs needed to treat Hepatitis C infections is very high. The cost of these drugs is of particular concern to state health authorities who are charged with providing health care for Medicaid recipients and […]

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04.13.17

Direct to Consumer Genetic Testing: Risks and Opportunities

By Katharina O Cathaoir

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 […]

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03.10.17

FEDERAL TOBACCO CONTROL DURING THE TRUMP YEARS – AND TOBACCO PRODUCT INSERTS

By Eric Lindblom

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 […]

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Thematic Areas: Food & Drug Law

02.17.17

Carfentanil

By Katie Gottschalk

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 […]

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12.22.16

Obama signs $6.3 billion Cures Act – But Does it Do More Harm than Good?

By Sonia Canzater

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 […]

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09.09.16

The Exorbitant Pricing of Pharmaceuticals is in the News. Again.

By Katie Gottschalk

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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11.17.15

Naturally Processed?

By O’Neill Institute

This post was written by Janelle Langan, a Global Health Law LL.M. student at Georgetown Law. Any questions or comments about this post can be directed to jl2009@georgetown.edu. Recent emphasis upon diet through consumer education, media coverage, and mobile food journaling applications has brought healthy eating to the forefront of the minds of consumers. A […]

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The views reflected in this expert column 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.

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