Since taking office, President Trump has done right by the scientific and patient communities by placing strong leaders at the Food and Drug Administration and the National Institutes of Health. After a four-month vacancy in the FDA’s top job, Dr. Scott Gottlieb now runs this essential agency, and Dr. Francis Collins is continuing his leadership…
The proposed budget unveiled Tuesday by the Trump administration doubles down on major cuts to biomedical research, fighting infectious disease outbreaks, health care for the poor, elderly and disabled, and prevention of HIV/AIDS. It restates the goals of the “skinny budget” the administration released in March, which was widely condemned by scientists and public…
Executive Summary CDER Director says US FDA needs to develop statistical and other guidances faster to keep up with the pace of science and drug development. The US FDA wants to speed up its policy-making process to better keep up with the speed of scientific advances affecting drug reviews. Center for Drug Evaluation…
The FDA Oncology Center of Excellence occupied a special place in the Obama White House moonshot program. Amid the moonshot’s big goals, the FDA center was concrete, manageable, and modestly priced, a reorganization that promised to revolutionize the agency’s handling of everything cancer. How is the place faring today? Not well, by…
The U.S. Senate voted on Tuesday to confirm Dr. Scott Gottlieb, a health policy expert and venture capitalist, as commissioner of the Food and Drug Administration, which regulates everything from food and drugs to tobacco, cosmetics and dietary supplements. The Senate voted 57-42 in favor of Gottlieb, a conservative physician and former deputy FDA…
Enacting a federal right-to-try law that circumvents FDA’s oversight of access to unapproved therapies no longer looks like a sure bet. Still, the debate over right to try has stimulated initiatives to give more patients who have run out of alternatives the chance to try experimental drugs and medical devices. Propelled by victories in…
Tom Price starts listening tour on drug pricing. The HHS secretary hosted patient and disease advocacy groups on Monday in the first of a series of meetings on drug prices, Pro’s Sarah Karlin-Smith first reported on Monday. Price’s expected to meet with additional groups focused on drug prices, according to a source close to…
Executive Summary US FDA Commissioner nominee favors making up-to-date, accurate information available to patients and providers, but will that translate to more freedom for sponsor communications? Scott Gottlieb admitted to not fully briefed on the US FDA’s off-label communications issues, but seems interested in policy tilting toward more information disclosure on drug uses. The…
Executive Summary Given that ‘right to try’ is intended to be a patient-centered proposal, patient organizations are a strong voice in opposition, working behind the scenes to revise – or entirely exclude – the legislation as part of the user fee package. But the bill also has powerful advocates among Senate Republicans and in the…
HHS Secretary Tom Price met with patient and disease advocacy groups at HHS today in the first of a series of meetings on drug prices, according to people who attended the session. Price is expected to meet with additional groups focused on drug prices, according to a source close to the administration who said HHS…
