User fees paid by the drug and medical device industries support the salaries of hundreds of FDA staff. Federal employee union contracts require FDA to give employees 60 days’ notice if the government won’t have enough money to pay them. If a user fee bill isn’t ready to go by August 1, FDA must send…
President Donald Trump announced his intention to name Norman “Ned” Sharpless to serve as the next NCI director. The appointment was announced late on June 9. Sharpless, director of the UNC Lineberger Comprehensive Cancer Center and the Wellcome Distinguished Professor in Cancer Research, will replace Douglas Lowy, who has served as acting director at…
Some of the most innovative thinking on display at this year’s American Society of Clinical Oncology meeting came not from cancer companies, but from FDA and groups of oncologists and patient advocates who are busy rethinking how cancer drugs should be developed. The meeting was chock-a-block with data readouts showing impressive response rates to…
FDA’s Oncology Center of Excellence (OCE) is currently not receiving funding from 21st Century Cures even though both a lawmaker and the agency head said they believed resources provided through the act were intended to go to the center. An FDA spokesperson told Inside Health Policy that FDA “is currently using existing agency funds to…
The fiscal 2018 U.S. budget issued by the Trump administration calls for steep cuts in health care and scientific research while heavily boosting defense spending and offering substantial tax cuts. Dubbed “A New Foundation for American Greatness,” the spending plan was touted as a “taxpayer first” budget by Mick Mulvaney, director of the Office of…
PMWC 2017 at Duke Co-Chair Ralph Snyderman, MD, introduced the two panelists for a discussion of “Increasing Patient Access to Investigational Drugs,” as the two leading people in the country working to make such drugs available to patients, and noting that for patients this is perhaps the best of times and the worst of times—best…
As part of our coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago, we spoke about patient participation in clinical trials with Julia Beaver, MD, acting director of the Division of Oncology Products 1, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, at…
The prescription drug user fee agreement that Congress must approve by the end of September is particularly important because it furthers some of the drug-approval process innovations in the 21st Century Cures bill passed in 2016. That bill requires the Food and Drug Administration (FDA) to take certain steps to incorporate biomarkers, real-world evidence, and…
EACH YEAR, the ASCO President chooses a theme for his or her term, which is not a trivial pursuit. Trying to think up something novel and catchy, yet not schmaltzy, is quite a challenge. However, in my year as Chair of the Scientific Program Committee for the 2010 ASCO Annual Meeting, then during my 3…
