Lawmakers are committed to reauthorizing drug user fee agreements well before the present ones expire at the end of September, a House of Representatives committee hearing was told Wednesday. But the process is complicated by the advent of a new administration and its policy and budget statements, while Congress discusses agreements that were hammered…
Executive Summary White House allowed agency to hire some new employees, but lawmakers remain concerned about federal hiring freeze’s effect on FDA. The US FDA apparently is reaping the benefits of an exemption to President Trump’s federal hiring freeze. And while the number of new hires has yet to be revealed, it appears several new…
The focus of a recent hearing of Senate Health, Education, Labor and Pensions (HELP) was the FDA’s user fee agreements, or monies the agency receives from drug and medical device manufacturers to accelerate the review process. But prior to the hearing, every Democratic member of the HELP committee signed a letter to Chair Lamar Alexander…
House lawmakers, FDA officials and industry stakeholders all praised the success of the agency’s breakthrough designation in lowering drug development times, and stressed that the pending Prescription Drug User Fee Agreement (PDUFA) will bring important resources to the breakthrough effort. The widespread commitment to the designation at a House hearing Wednesday (March 22) is likely…
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.…
