Category Archive for: Dr. Joseph Gulfo

The Hill: Different approach to FDA user fee reauthorizations needed by Joseph Gulfo

Initially passed in 1992 and 2002, respectively, PDUFA (Prescription Drug User Fee Amendments) and MDUFA (Medical Device User Fee Amendments) require reauthorization every five years. Hearings for the 2017 reauthorization are being scheduled to take place throughout 2016. Forty-five percent, or $2.2 billion, of the Food and Drug Administration’s (FDA) $4.9 billion fiscal 2016 budget…

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The Hill: Fixing the FDA’s broken combination products policies by Joseph Gulfo

One of the most fertile areas of medical innovation today is the combination of devices and drugs. These products, also known as combination products, are comprised of two or more regulated components, i.e., drug and/or device and/or biologic, and don’t fit nicely into existing regulatory pathways, yet comprise roughly one-third of all products in development…

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CNBC.com: Hedge funds, ‘reverse trolls’ crushing biopharma innovation by Dr. Joseph Gulfo

Prior to September 2012, a company faced with a patent-infringement lawsuit brought by a patent troll (an entity that acquires patents just to seek cash payouts from other patent holders), your only recourse to invalidate the troll’s nuisance patent was through the federal courts—a very costly and time- consuming effort. In an attempt to increase…

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Daily Caller Opinion: Why The 21st Century Cures Act is a Mistake by Dr. Joseph Gulfo

On May 21, the 21st Century Cures Act was passed by the House Energy & Commerce Committee unanimously (fifty-one to zero). Since then, a great deal of PR has been devoted to securing its full passage in the House and Senate. I do not believe that the bill should be passed for five reasons: 1. It rewards bad behavior — In July…

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The Hill: Go on, take the money and run, as usual by Joseph Gulfo

Why would an agency charged with promoting the public health need to be told to consider patients’ perspectives? Further, why would the Food and Drug Administration need be given two years to come up with a “structured risk benefit framework” for the meaningful incorporation of patient experience data into the regulatory decision-making process when the…

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The Hill: Why we need a Medical Innovation Impact Index by Joseph V. Gulfo, MD, MBA

Regulatory incentives, like 21st Century Cures, while well-intentioned, actually have the reverse effect on medical innovation. Yet, we continue to see more and more of these programs, rather than what is truly needed – a serious root cause analysis of the dysfunction at the FDA, which cripples medical advances. Moreover, a system of evaluating new regulations relative to their…

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The Hill: PR efforts at the FDA put the cart before the horse by Joseph V. Gulfo, MD, MBA

Despite the fact that the FDA continues to perform woefully relative to its statute-defined target review goals by PDUFA and MDUFA, its campaign of public relations continues unabated. It is truly unprecedented to see the FDA Commissioner and high ranking officials address the public as often as we have seen over the past 6 years.…

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