Category Archive for: Opinion

The Hill: A hearing brought to tears over Right to Try legislation by Joseph V. Gulfo

Last week, Sen. Ron Johnson (R-Wis.) introduced new Right to Try (RTT) legislation intended to prevent federal agencies from interfering with or blocking the implementation of RTT laws that have been passed in 28 states to date. I attended Johnson’s press conference announcing his RTT bill — the Trickett Wendler Right to Try Act of…

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Our American Network: On Ending the Prescribe Don’t Tell Charade for Off-Label Drugs

Dr. Joseph Gulfo is the executive director of the Rothman Institute of Innovation and Entrepreneurship at Fairleigh Dickinson U. He wrote Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances and this op-ed for the WSJ, “Ending the Prescribe Don’t Tell Charade for Off-Label Drugs.” Listen to his interview with Lee Habeeb of…

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The Hill: The FDA Needs A Conditional Approval System by Joseph V. Gulfo

The Food and Drug Administration (FDA) has long shunned the concept of conditional approvals – the granting of approval to market safe drugs with some indicia of activity for a period of time while additional studies are conducted to support full approval. The FDA’s Accelerated Approval Program allows for earlier approval of drugs that treat…

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Wall Street Journal: Ending the Prescribe-Don’t-Tell Charade for Off-Label Drugs by Joseph V. Gulfo

Earlier this month the Food and Drug Administration reached a settlement with Amarin, a small pharmaceutical firm, allowing it to promote its drug Vascepa for treatments that the agency had not specifically approved. The company had sued the FDA, claiming a First Amendment right to “engage in truthful and non-misleading speech.” The agency maintained that…

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The Hill: The FDA must return to its public health mission by Joseph V. Gulfo

I was contacted by the Senate Committee on Homeland Security and Governmental Affairs following the release of my paper, “The Role of the FDA for the 21st Century” to testify at the Feb. 25 hearing entitled “Connecting Patients to New and Potential Life Saving Treatments.” The hearing focused on identifying possible barriers that prevent patients…

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The Hill: FDA must focus on drug safety and effectiveness, not patients’ life outcomes by Joseph Gulfo

As the Senate Committee on Homeland Security and Governmental Affairs meets next week for a hearing on “Connecting Patients to New and Potential Life Saving Treatments,” it is important to remember the appropriate role of the Food and Drug Administration (FDA) in promoting the health of Americans. (Full disclosure: I have been called as a…

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The Hill: Appropriate oversight is needed to change FDA behaviors, not more laws by Joseph Gulfo

Oversight of the executive branch is a main duty of Congress that flows from the many and varied express powers of Congress in the Constitution, including appropriating funds, enacting laws, and impeaching and removing civil officers. However, as former House Speaker Tip O’Neill (D-Mass.) once exclaimed, “Members like to create and legislate, but we have…

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The Hill: Medicare negotiating with pharma is not the answer by Joseph Gulfo

The concept of Medicare negotiating drug prices directly with manufacturers has been raised throughout 2015 by the Senate and the president, but never more vocally than over the last month by presidential candidates Hillary Clinton and Sen. Bernie Sanders (I-Vt.) following Turing Pharmaceuticals’ attempted 55-fold increase in the price of Daraprim and Valeant Pharmaceuticals’ receipt…

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The Hill: How the FDA can settle the off-label use vs. off-label promotion conflict by Joseph Gulfo

Both the U.S. Court of Appeals for the Second Circuit and district courts have ruled against the Food and Drug Administration (FDA) in two widely publicized cases involving the agency’s enforcement of misbranding policies to prohibit off-label drug promotion, the intention (encouragement of physicians and advertising) of a drug manufacturer to have its drug used…

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Forbes.com: Patients Are Tired Of Waiting On The FDA by Joseph Gulfo

The Food and Drug Administration (FDA) regulates 25% of the U.S. economy. For fiscal year 2016, the FDA’s budget is $4.9 billion, with $2.2 billion (or 45%) generated from user fees, payments collected by the FDA from companies submitting new drug, biologics and medical device applications for review. They were authorized under the Prescription Drug User Fee Act (PDUFA, 1992) and Medical Devices User Fee Act…

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