Unbiased Analysis of Today's Healthcare Issues

Archive for the 'Regulation' Category

How to regulate precision medicines

Currently, pharmaceutical treatments that are used in the U.S. need to gain an approval from the FDA.  The FDA’s approval is contingent on a demonstration of efficacy and safety in a randomized controlled trial (RCT).  However, precision medicine makes the standard FDA approval problematic. As described in Breckenridge et al. (2016), in the precision medicine […]

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Dismal Arithmetic of Hepatitis C Treatment?

The American Journal of Managed Care has an interesting special issue on treatment for the hepatitus C virus (HCV).  Jay Bhattacharya provides the introductory commentary, and starts off with the following. Although the medical prospects facing patients with hepatitis C virus (HCV) have never been better, the prospect of gaining access to a cure is another […]

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How to prevent another EpiPen controversy

Dana Goldman–my colleague at PHE and a professor at USC–offers three suggestions on how to prevent generic products from increasing their prices drastically as occurred in the EpiPen saga.  In Stat News, he makes three recommendations: First, Congress should mandate that the Federal Trade Commission report on the availability of all such drugs and devices […]

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Incentives for investing in “off label” trials

Aaron Carroll of the Incidental Economist draws on a column from his colleague Austin Frakt in The Upshot to explain why there is not more research into off-label uses of patented or generic drugs.  

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Off Label Drug Use

Approximately one in five prescriptions for drugs in the US are for off label use.  In some cases, this may be inapprorpiate as there is typically limited clinical evidence supporting off label use.  In other cases, off label use is approrpiate.  Clinical trials rarely enroll children or pregnant women and thus medictions are often not […]

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Will value-based pricing be coming to the U.S.?

The answer may be yes.  One of the big inpediments to value-based pricing of pharmaceuticals was that any discount given to any single organization based on outcomes needed to be reflected in the Medicaid price.  Since outcomes are subject to random noise, there will inevitably be health plans that end up getting a low price due to worse than expected […]

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Brexit = upheaval for drug makers

Will the European Medicines Agency (EMA) need to re-located after Brexit? According to a Reuters story, the answer is yes. The EMA is a London-based organization that approves treatments for all EU countries. As the UK leaves the EU, however, EMA is expected to have to relocate. 600 individuals work for EMA. More important is […]

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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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The cost of allowing kids to remain dependents up to 26 years

Many of the provisions of the Affordable Care Act include provisions requiring health insurers to do certain things.  Variability of premiums are regulated, certain services are mandated (e.g., free annual check-up) and minimum benefits packages are set on the health insurance exchanges.  One seemingly innocuous provision of the ACA is that children are allowed to remain […]

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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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