FDA

The first half of 2016 has already been a very busy year for the Food and Drug Administration as it finalized and published its new comprehensive set of tobacco deeming regulations, continued its implementation of a new food safety system in compliance with the Food Safety Modernization Act, and released a new set of pain medication guidelines related to opioid addiction and abuse. All of these developments have come under newly appointed FDA commissioner Robert Califf, M.D. His top priorities also include strengthening FDA’s workforce, improving medical product safety, and supporting the President’s National Cancer Moonshot Initiative and the Precision Medicine Initiative. Dr. Califf will...
Dear Research Advocate: In the multi-faceted context of discouraging new data that shows an increasing incidence of suicide, rapidly rising prescription drug abuse, and widespread pain and suffering due to the heroin epidemic, the House is working on legislation to address opioid abuse , approving more than a dozen bills that will be packaged and considered on the floor in early May. This is important bipartisan progress in combating challenges of frightening scope, extending beyond addressing addiction and abuse to effectively meeting the challenge of chronic pain. Even as we commit to working harder to activate what we know works in terms of prevention and treatment, we must learn much...
Dear Research Advocate: A report out this week by United Health Foundation concluded that an astonishing 72% of Americans have at least one of the five most impactful “unhealthy behaviors” (smoking, physical inactivity, insufficient sleep, excessive drinking or obesity). A White House report out this week quantifies the massive public health threat brought on by climate change and outlines the emerging issues, supporting evidence and the research required to curb these predicted effects. The need for improved public health is more evident then ever, and public health research is the best way to develop evidence-based, outcome-oriented interventions. Good thing it’s National Public Health...
President Obama’s decree proclaiming April 4 – 10 National Public Health Week focuses on several key objective: stemming the tide of infectious disease like Zika; improving access to healthcare domestically and globally; promoting healthy behaviors in adolescents; preventing opioid and illicit drug abuse; decreasing gun violence; addressing climate change-related health issues; and improving access to mental health resources. National Public Health week is an opportunity to reflect on the pivotal role public health research and practice play in advancing the wellbeing of Americans and populations across the globe, and recognize the individuals, organizations and agencies that carry out...
Increasing funding for federal health research agencies to respond to health threats, harnessing the power of precision medicine and other cutting-edge research and keeping the needs of the patient front and center, were some of the key points shared by Dr. Robert Califf, Commissioner of the Food and Drug Administration (FDA) and Senator Amy Klobuchar (D-MN) during Research!America’s 27th Annual Meeting of Members held at the Willard Intercontinental Hotel in Washington, D.C., on March 16. “I remain excited about and dedicated to direct involvement with consumers and patients,” said Dr. Califf. He emphasized that the FDA’s mission is not only to protect safety and promote innovation but to...
Dear Research Advocate: Three outstanding speakers addressed Research!America’s annual meeting of members yesterday. Newly confirmed FDA Commissioner Dr. Robert Califf kicked off the meeting, outlining his priorities for the agency. Having known Dr. Califf for some time, I wasn’t at all surprised to hear how determined he is to ensuring FDA engages the patient perspective as it works to improve policies and processes. For example, he underscored how important it is to calibrate risk/benefit calculations to take into account the seriousness of an illness and the availability of treatment options...in other words, how important it is to think like a patient, not for a patient. Bravo! Senator...
Dear Research Advocate: Our Annual Members Meeting and Advocacy Awards Dinner are coming up on March 16. There is still time to register for both the meeting , where we will hear remarks from Senator Amy Klobuchar (D-MN), FDA Commissioner Robert Califf, M.D., and ALS patient-advocate Lorri Carey, and the dinner , where we will be presenting awards to a distinguished group of research and innovation champions and world class advocates. Join us for an inspiring day! Yesterday, the Senate HELP committee passed a second set of seven bipartisan “Innovations” bills, which focus on a range of topics including combination products, patient input on all aspects of clinical trials and health IT. See...
Dear Research Advocate: I’m pleased to announce that Senator Amy Klobuchar (D-MN) will be giving remarks at our Annual Meeting on March 16 at noon at the Willard Intercontinental Hotel. We will also be hearing from newly confirmed FDA commissioner Dr. Robert Califf and ALS patient advocate Lorri Carey. I hope you’ll join us at the annual meeting as well as at the Annual Advocacy Awards Dinner that evening. See our ad in Roll Call . Senators Patty Murray (D-WA) and Elizabeth Warren (D-MA) were joined by the eight other democratic members of the Senate HELP Committee today as they introduced the National Biomedical Research Act . This bill would provide a new mandatory funding stream for NIH...
Research conducted at Louisiana institutions benefits not only those in the state but also people across the country, said Senator Bill Cassidy (R-LA) during his opening remarks at the Louisiana Research Summit held on February 16 at the University Medical Center in New Orleans. The summit, co-hosted by Research!America, assembled federal, state, university, and business leaders to discuss current challenges and opportunities for advancing research in Louisiana. At several junctures during the summit, Senator Cassidy stressed the importance of making Louisiana "easy to work with" by lowering administrative barriers and building on success to date. He also emphasized that the summit was not...
Dear Research Advocate: This week I had the pleasure of participating in a research “summit” hosted by Louisiana State University (LSU), Research!America, and our honorary host, Senator Bill Cassidy (R-LA). I moderated a powerhouse panel featuring NIH Director Francis Collins, M.D., NSF Director France Cordova, Ph.D., and FDA’s Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, M.D., each of whom offered state-specific illustrations of the impact federally-funded Louisiana research has had to date, and signalled the many opportunities Louisiana has to do more. This standing-room-only, high-content gathering drew research, academic, business and philanthropic leaders...

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Without continued support for health research, many of the most promising young scientists, their ideas and a myriad of potentially life-changing scientific breakthroughs will vanish into oblivion.
Paul Marinec, PhD; University of California San Francisco