FDA

Watch the videos from each panel, read the transcript , view the photo gallery and read the WebMD live recap . “The biomedical research enterprise underpins the health of the nation and much of the world, and is in dire need of substantial infusion to meet the great medical needs of our time,” said William N. Hait, M.D., Ph.D. , global head, Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, the keynote speaker at the 2016 National Health Research Forum, added that we’re losing time in addressing threats like the Zika virus, Ebola and cancer while waiting for funding to improve for biomedical research. The program, held Thursday,...
Partnerships between patient groups, industry, government and academia are accelerating the research and development of new treatments for rare diseases, many of which have no effective therapies. As a result of the Food and Drug Administration’s (FDA) Orphan Drug Designation, eligible companies receive incentives for product development such as tax credits for qualified clinical testing and new drugs are reaching patients sooner. Since 1983, more than 400 drugs and biologic products for rare diseases have been developed, far outpacing the number of products that were available some 40 years ago. Amyotrophic lateral sclerosis (ALS) is among the nearly 7,000 rare diseases where very few...
Dear Research Advocate: Earlier this week, the House passed an inadequate proposal for $622.1 million in emergency Zika funding, falling far short of the bipartisan Senate proposal of $1.1 billion passed this week, not to mention the President’s request of $1.9 billion. Appropriations subcommittee Chairman Cole (R-OK-04) has stated that subsequent Zika funding will come in the next appropriations cycle, but public health experts tell us we cannot wait. (This is especially true since the pattern of the last many years is for appropriations to go undetermined until almost calendar year end.) Summer months are approaching and half the continental U.S. is home to potential disease-carrying...
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...

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Funding research gives all of us a better chance of living a healthier life.
Pam Hirata, heart disease survivor