My sister Gale had exhausted every option. Metastatic cancer raged through her body, defeating all conventional treatments. She faced a final decision: succumb to the disease, or wage one last battle with an experimental bone marrow transplant known to kill 20 percent of patients. Gale chose to fight, opting to use the unproven therapy…
U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, the White House said on Friday. If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to dramatically cut regulations…
Dear President Trump, During your speech to Congress last week, you took a whack at the Food and Drug Administration for its “slow and burdensome” approach toward approving medicines. You then suggested that if “we slash the restraints” on the agency, Americans will be blessed with more miracle cures. To be sure, the FDA is…
Two days before Christmas, the Food and Drug Administration gave Thomas Crawford an unexpected gift: approval of the first treatment ever for a devastating genetic disease that causes muscle wasting in babies and often results in death at an early age. The drug “is nothing short of oh-my-God amazing” when given to infants who have…
An alliance of drug companies and research advocacy groups is calling for Congress to appropriate $2.8 billion for FDA in fiscal 2018 — a $78 million increase from fiscal 2016. The additional funds would help the agency keep up with growing responsibilities and could improve food safety, drug quality and implementation of 21st Century Cures,…
Reauthorization of the FDA user fee programs is usually one of the surest bets on the congressional agenda. But not this year. These crucial agreements with drug and device makers, which provide about half of the FDA’s annual budget, are facing unusual obstacles ahead of a fall deadline for approval. And without congressional action,…
Executive Summary Existing regulatory authorities could be optimized to speed development of promising pediatric cancer therapeutics, particularly those that don’t work in adult cancers. Accelerating the development of pediatric cancer therapeutics and diagnostics will be a key focus for the US FDA’s new Oncology Center of Excellence (OCE). “As part of the newly…
A cancer patient advocate worries that President Donald Trump’s hiring freeze could put a crimp in FDA’s newly launched Oncology Center of Excellence (OCE), an initiative aimed at speeding patient access to cancer treatments and which is viewed as a possible model for creation of other disease-focused centers in the future. FDA formally launched OCE…
Key lawmakers hope to move legislation this year that aims to improve federal oversight of laboratory tests. And now two main industry groups who were previously in opposition on the issue are aligning on a strategy to lobby Congress to advance an overhaul. Laboratory developed tests, or LDTs, are currently regulated by the Centers…
Our nation’s health regulators stand at a crossroads. In one direction lies advancement through cutting-edge programs; in the other are practices that no longer reflect our best scientific insight. Health officials want to move forward, but external conditions are holding them back. President Trump can help our nation’s public health talent take the promising…
