Food and Drug Administration

Rethinking the ways in which we address mental health issues is critical in the development of new and innovative technologies, treatments, and strategies. Instead of simply providing a diagnosis, treatment strategies should focus on the entire community of individuals affected by mental illness, said Dr. Arthur Evans, CEO of the American Psychological Association. At the “Tackling Mental Health Through Innovation” forum hosted by CQ Roll Call on September 19 in Washington, D.C., Evans emphasized the importance of intervention strategies as a top priority to ensure at-risk individuals receive necessary care. “Let’s make sure that within the community we have the infrastructure, the...
Dear Research Advocate, In a week with lots of mixed signals on health care, we released new survey data that shows a striking increase in public support for empowering patients (and we are all patients!) to participate in clinical trials. A strong majority say joining a clinical trial is as valuable as donating blood. And a new question shows the public would value providers discussing clinical trials as a routine part of health care. These findings come just as NIH’s “All of Us” initiative launches a new grant program to encourage enrollment in the ambitious one million-enrollee clinical research effort. Read more about our survey , and plan to attend our National Health Research Forum in...
Dear Research Advocate, House leaders will likely act soon after the July 4 recess to pass an FY18 budget resolution. No word on when the Senate might act. Reportedly, the House budget resolution would instruct appropriators to spend more on defense than in FY17, significantly more, in fact, than is allowed under the defense “sequestration cap” established by the 2011 Budget Control Act (BCA). In contrast, non-defense discretionary (NDD) spending would be limited to a level at least $5 billion below the NDD budget cap. This increase in defense and decrease in NDD spending is actually more “moderate” than the $54 billion reallocation proposed in the president’s budget. And neither the...
Dear Research Advocate, Congress is making progress in reauthorizing the FDA user fee programs, which is good news. According to officials at FDA, if the July 31 deadline for the “UFA” reauthorizations is missed, “reduction in force” (RIF) notices will be sent to one-third of the staff who review medical devices and a full 70% of those who review “small molecule” prescription drugs. The impact would probably be at least that dramatic for CBER, the center that reviews biologics. If the process stalls (or looks likely to), we’ll let you know and provide advocacy options! During his confirmation hearing before the Senate HELP committee yesterday, FDA Commissioner nominee Dr. Scott Gottlieb...
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...
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, The President’s signature on hard fought funding and tax legislation was enough to end the year on a high note, but there’s more good news: In an interview on C-SPAN , Senate HELP Committee Chairman Lamar Alexander (R-TN) said what many of us have been waiting to hear: “Number one, what we want to turn our attention to [in 2016] is what we call the Innovation Bill.” After the 21st Century Cures pay-fors were used to help offset lost revenues in the FY16 Omnibus/Tax package, the prospects for mandatory NIH and FDA funding seemed weak. However, not only did Chairman Alexander reiterate his support for mandatory funding, but House Energy and Commerce Committee Chairman...
The president’s FY14 budget proposal offers a lifeline for medical research to replace sequestration’s damaging footprints. The budget includes $31.3 billion for the National Institutes of Health, as well as increases for the Food and Drug Administration and National Science Foundation. These increases would take our nation in the right direction, but we’re concerned that budget proposals from Congress – one from each of the House and Senate – unlike the president, fail to reverse sequestration. Sequestration, 10 years of across-the-board spending cuts, will drag our nation down from its leadership position in research and development as other countries aggressively ramp up investments,...
The following is a statement from Research!America President and CEO Mary Woolley on the Senate’s passage of FDA user fee legislation: “Senate approval of the FDA Safety and Innovation Act demonstrates the willingness of lawmakers to prioritize the health and safety of patients. The bipartisanship displayed in crafting and moving the bill through Congress underscores the strong support for bringing lifesaving treatments to patients in a safe, efficient and speedy manner. The additional funding for review of prescription drugs and medical devices, along with key policy changes, will accelerate the approval process and address issues that have for too long disrupted the flow of innovative new...

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