The Affordable Care Act (ACA) has improved access to cancer care for millions of Americans, and many new drugs and new indications for existing cancer drugs were approved in 2016, but there are frontiers in improving cancer care that include information barriers, disparities in the availability of rural care, and stressors on physicians and oncology…
Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI). And, in her second straight day of testimony on user fees before Congress, Janet Woodcock, director of the…
The US FDA is considering elevating patient engagement to a more visible position by establishing a central office for the programs. The agency said in a Federal Register notice expected to be published March 14 that it is seeking comments on its idea to create an Office of Patient Affairs. It is intended…
The Food and Drug Administration may establish an Office of Patient Affairs, the agency announced in a Federal Register notice Monday. Such an office has the potential to elevate patient advocates’ perspective, which some fear is already too influential at an agency where science is supposed to take priority over emotional appeals from the…
Scott Gottlieb, a former deputy commissioner of the U.S. Food and Drug Administration, is President Donald Trump’s choice to lead the agency, according to an emailed statement from the White House. Gottlieb, 44, served in several senior positions at the FDA during the George W. Bush administration. He has talked extensively about how…
President Trump announced late Friday that he will nominate Scott Gottlieb, a conservative physician and businessman with deep ties to the pharmaceutical industry, to be commissioner of the Food and Drug Administration. If confirmed, Gottlieb would bring a strong pro-industry, deregulatory approach to an agency that Trump has criticized as being overly restrictive.…
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…
