JosephGulfo

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So far Joseph Gulfo has created 73 blog entries.

Response to Forbes.com Opinion Article: Even If Donald Trump Changed The FDA Drug Approval Process, Patients Wouldn’t Benefit

Yesterday, Forbes.com published a critique of the solutions that I proposed to cut the red tape at the FDA in my recent Wall Street Journal opinion piece entitled “A Trumpian Cure for the FDA’s Chronic Lethargy.” To LaMattina's claim that the role of the FDA is to ensure clinical utility, I refer you to the [...]

Nov 30 2016|Blog|

Wall Street Journal: A Trumpian Cure for the FDA’s Chronic Lethargy

Dr. Joseph Gulfo penned an op-ed for the Wall Street Journal titled "A Trumpian Cure for the FDA's Chronic Lethargy." You can read the full-oped at WSJ.com.

Nov 22 2016|Media|

Opinion Journal: How to Fix the FDA

Dr. Joseph Gulfo joins Mary Kissel on WSJ Opinion Journal to discuss how the Trump Administration can streamline drug regulation, encourage innovation, and lower drug prices.

Nov 22 2016|Media|

Our American Network: 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 piece for the WSJ. Read More…

May 19 2016|Media|

The Hill: A hearing brought to tears over Right to Try legislation

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 2016 — and was given the opportunity to speak at the briefing on RTT and the Right to Try Act of 2015 (H.R. 3012), both of which took place in Washington on Tuesday, May 10 — National ALS Advocacy Day. Read More…

May 17 2016|Media|

The Hill: Time for National Right to Try Legislation

The goal of Right to Try laws is to allow patients with terminal diseases access to promising new treatments that are being safely used in clinical trials, but are not yet available on pharmacy shelves. The laws protect doctors and their institutions from the legal ramifications stemming from prescribing therapies that are not yet Food and Drug Administration (FDA)-approved to patients with no alternatives. Read More…

May 10 2016|Media|

Forbes: The FDA Needs A Conditional Approval System

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. Read More…

May 5 2016|Media|

Ending the Prescribe-Don’t-Tell Charade for Off-Label Drugs

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 the settlement was “specific to this particular case and situation.” Read More…

Mar 27 2016|Media|

The Hill: The FDA Must Return to its Public Health Mission

The hearing focused on identifying possible barriers that prevent patients from accessing new and potentially lifesaving therapies, often in the face of terminal or debilitating conditions. The principal driving force behind the hearing was the Right to Try Law movement initiated by the Goldwater Institute, which has been approved in 24 states and is being considered for federal consideration with bipartisan support. Read More…

Mar 4 2016|Media|

The Hill: FDA Must Focus on Drug Safety and Effectiveness, not Patient’s Life Outcomes

The FDA’s mission is to provide doctors in the medical ecosystem with access to safe and effective new drugs, biologics, and devices in a prompt, efficient, and timely manner. The medical marketplace, which involves patients, payers and physicians, functions to then identify, and preferentially use, the most appropriate products in individual patients. This is how the law was designed. Read More…

Feb 19 2016|Media|