Unbiased Analysis of Today's Healthcare Issues

Off label prescribing: Q&A

The Duke-Margolis Center for Health Policy has a great overview of some of the issues related to off-label prescribing.  Below is a summary of some key points from this article. What is off-label prescribing? Off-label prescribing and use can take many forms, such as use of an approved drug for an unapproved clinical indication, use at […]

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What is the FDA doing about opioids?

The FDA is planning to put additional scrutiny on the use and approval of opioids in order to prevent opioid abuse and addiction.  Here is their plan: Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects Convene an expert advisory committee before approving any new drug application for an […]

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FDA to Consider Patient Preferences

Typically, the FDA evaluates drugs and devices based on whether they are safe and effective. Patient treatment preferences play little to no role in whether a drug or device is approved by the FDA. However, times are a changing. On Wednesday, the FDA released draft guidance whereby they recommend the inclusion of patient preference information […]

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Does your FitBit need to be FDA approved?

Right now, the answer is no, but in the near future, this may no longer be the case. The FDA has released a draft guidance on how it will regulate the new generation of wearable technology.  This guidance  says it will not regulate “general wellness” products like the FitBit. However, if the wearable cites health benefits for […]

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How the FDA evaluates Cancer Drugs

The Food and Drug Administration (FDA) reviews and approves all drugs. But what criteria does the FDA use to evaluate new drugs? Namely that they are effective (i.e., improve health outcomes) and safe (i.e., have limited adverse health events). In a 2007 guidance document from the FDA’s Center for Drug Evaluation and Research (CDER) and […]

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Regulating 23andMe

A number of companies, such as 23andMe, allow individuals to sequence their own genes in order to attempt to determine if they have an elevated risk for certian diseases. This sector has largely been unregulated…until now. The Economist reports, On November 22nd the FDA…sent a stern letter to 23andMe, a genetic-testing firm. Despite “more than […]

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Trends in Drug Approvals: 1987–2011

Many individuals have claimed that new drug approvals are declining over time.  A recent article by Lanthier et al. (2013) finds the following trends. Courtesy of Health Affairs. Drug approvals seem to be fairly steady over time, except for a decline in addition-to-class drugs. Why is this? The authors hypothesize as follows: Today we see […]

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The end of the FDA?

When Alfred Caronia worked for a drug company, he promoted some drug’s off-label use. The Department of Justice did not take kindly to Caronia’s behavior and sued him for violating the Food, Drug, and Cosmetic Act (FDCA). He was convicted, but appealed the conviction. Caronia argued that this commercial speech is protected by the first […]

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Why are there so few vaccine suppliers?

In many cases, only a handful of suppliers produce vaccines for a given disease.  In fact, for several vaccine types the U.S. has fewer suppliers than countries with a smaller market and a higher level of government purchase. One reason for this finding could be strict government regulation.  All vaccines must be approved by the […]

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Setting FDA Standards

To what standard should the FDA hold new drugs?  The FDA has a number of choices.  Drugs companies could be required to prove that the drugs they make: Do no harm. Are more effective than placebos Are more effective than existing drugs Are more cost-effective than existing drugs, or Are both more effective and more […]

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