Tag: Food and Drug Administration

American Patients Can Access Far More New Cancer Drugs than Others Can »

New research by scholars at the University of Pittsburgh shows that American patients have significantly better access to new cancer medicines than their peers in other developed countries: Of 45 anticancer drug indications approved in the United States between January 1, 2009, and December 31, 2013, 64% (29) were approved by the European Medicines...
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Congress Just Punched a Big Hole in Obamacare »

President Obama signed the 21st Century Cures Act on December 13. Promoted as a pro-innovation bill, the new law will improve the Food and Drug Administration’s regulatory processes; as well as fund Vice-President Biden’s Cancer Moonshot, the National Institutes of Health, and steps to reduce the opioid epidemic. However, the final version of the...
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The FDA Cannot Hire Staff with Starting Salaries of $160,000 »

Would a starting salary of just above $160,000 turn you off? Well, maybe if you had a scientific PhD and had to wait four months before the employer could decide whether to hire you or not, you would find a spot elsewhere. This is the situation the Food and Drug Administration finds itself in,...
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Good and Bad News on Generic Drug Approvals »

A solution to expensive patented medicines is generic competitors. The United States has struck a pretty good balance between innovation and low prices through the Hatch-Waxman (1984) Act, which specified patent terms for newly invented medicines, and a pathway for generic competitors to enter the market after a period. One obstacle to generic entry...
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Who Benefits from “Right to Try” Laws? »

The Goldwater Institute has had great success getting states to pass “Right to Try” laws. Right to Try allows a desperately sick patient to take an experimental new medicine before the FDA has approved it. Since I last wrote about this in May 2014, 31 states have passed Right to Try. Further, U.S. Senator...
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One Solution to the EpiPen Crisis: Repeal Durham-Humphrey! »

Posturing politicians on Capitol Hill conducted a hearing a few days ago during which they grilled Heather Bresch, CEO of Mylan N.V., maker of EpiPens. Prices of EpiPens have skyrocketed in the past few years (which I have discussed here and here). The politicians were more interested in wagging their fingers and tut-tutting at...
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EpiPen: A Case Study of Government Harm »

Much has been written about the dramatic price hikes for EpiPen, a product that injects a drug that counters severe allergic reactions (anaphylactic shock). According to Aaron E. Carroll, writing in the New York Times, the real (inflation adjusted) price of EpiPens has risen 4.5 times since 2004. Both Carrol and the Wall Street...
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FDA Driving Drug Prices into Stratosphere »

BloombergBusiness has another story of a jaw-dropping price hike for a very old medical. In this case, Colchicine, a gout remedy so old that the ancient Greeks knew about its effects, used to cost about 25 cents per pill in the U.S. Then in 2010 its price suddenly jumped 2,000 percent. How did this...
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Game Developers Face Final Boss: The FDA »

[This piece was later published by Newsweek and the Foundation for Economic Education.] “Absent the FDA, Americans would be healthier and happier.” —Robert Higgs As I drove to work the other day, I heard a very interesting segment on NPR that featured a startup designing video games to improve cognitive skills and relieve symptoms...
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Victory for Free Speech in Medicine »

Judges are chipping away at government censorship of communications about prescription drugs. The Food and Drug Administration exerts great power over a medicine’s label, which describes the medicine’s therapeutic claims. Drug makers and the FDA sometimes spend years negotiating a label. The FDA regulates both safety and “efficacy.” So, a drug maker has to...
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