Tag Archives: FDA
The House and the Senate have begun deliberations on funding levels for NIH, CDC, AHRQ, NSF and FDA for FY15. Pressure to cut federal spending this midterm election year is enormous, and we need advocates to reach out to their representatives. Members in both houses of Congress are accepting input from constituents on which priorities they should fight for. Let your representatives know that combating disabling and deadly diseases is a national imperative, and funding for the agencies committed to this fight should be included on their list of appropriations priorities. Contact them TODAY and share this alert on Facebook, Twitter and with your networks.
Dear Research Advocate:
The president’s budget for FY15 was released Tuesday. While mostly symbolic, the president’s funding recommendations often serve as the “first bid” in the negotiations that result in agency funding levels. That is why the president’s proposals for the agencies that collectively drive medical progress and play such a pivotal role in the health and safety of Americans are of such concern.
The president’s budget proposes only slight increases for NIH, FDA and NSF in FY15, and significant cuts for CDC and AHRQ. As I said in The Huffington Post and in other media, President Obama’s budget does not reflect the potential the U.S. has to advance scientific discovery or medical progress; he sets the bar — and the nation’s sights — much too low! At a time when our global leadership is on thin ice, America needs a bold plan to advance research and innovation. See Research!America’s statement on the president’s budget here. Continue reading →
The president’s budget does not reflect the potential the U.S. has to advance scientific discovery. While welcome, the minor increases for the National Institutes of Health, the National Science Foundation, and the Food and Drug Administration diminish our ability to accelerate the pace of medical innovation, which saves countless lives, helps our nation meet its solemn commitment to wounded warriors, and is a major driver of new businesses and jobs. We’re also disappointed with reduced funding for the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention. AHRQ and CDC cannot be neglected in the name of deficit reduction, and it is truly disturbing that the president’s budget treats those crucial agencies in that manner. The capacity to improve health outcomes and health care efficiency, stem the explosion in chronic diseases, and protect the security of our nation in the face of lethal, drug-resistant infections and international pandemics all hinge on the expertise and resources available to these agencies. We must expand investigations into cancer clusters, deadly meningitis outbreaks and research crucial to bioterrorism preparedness, not reverse course. These funding levels also jeopardize our global leadership in science — in effect ceding leadership to other nations as they continue to invest in strong R&D infrastructures that have already begun to attract our best and brightest innovators. We simply cannot sustain our nation’s research ecosystem, combat costly and deadly diseases like Alzheimer’s and cancer, and create quality jobs with anemic funding levels that threaten the health and prosperity of Americans. The administration and Congress must work together to boost funding for federal research and health agencies in FY15 and end the sequester in order to truly meet the level of scientific opportunity.
The last day in February marks the annual International Rare Disease Day, first celebrated in 2008 by European coordinators the European Organization for Rare Diseases (EURORDIS). For the past five years, the United States has participated in this effort thanks to the hard work of the National Organization for Rare Disorders (NORD) and other committed alliances and patient advocacy groups.
Rare diseases are classified in the U.S. as illnesses affecting fewer than 200,000 individuals – about 0.005% of Americans. These patients and their families often struggle to be heard and there are major gaps in research on treatments and cures due to the small percentage of the population impacted by these diseases. However, advocacy groups across the nation, often coordinated by patients and their families, are leading the way to increase the voice of those with rare diseases and to ensure research on these illnesses receives well-deserved funding. Three examples include:
- The Progeria Research Foundation has been fighting to increase awareness and support of Progeria since 1999. Hutchinson-Gilford Progeria Syndrome (HGPS, Progeria) is a disorder that causes accelerated aging that eventually leads to pre-mature death due to heart disease. Drs. Leslie Gordon and Scott Berns, along with their son Sam who passed away in January from the syndrome, have been vocal advocates on Capitol Hill and were featured in the recent HBO special “Life According to Sam.” Funding raised by PRF contributed to the 2012 discovery of the first-ever treatment for children with the lethal disease. The Progeria Research Foundation will be honored by Research!America with the Paul G. Rogers Distinguished Organization Advocacy Award on March 12, 2014. Continue reading →
Dear Research Advocate:
The omnibus appropriations bill about to become law demonstrates that bipartisanship and pseudo-regular order is achievable. We won’t know for sure if we have true “regular order” until Congress proceeds through the FY15 appropriations process in a timely manner — something that hasn’t happened for many years. The importance of regular order is that the public’s interests are heard from in hearings, and every Member of Congress participates in priority-setting instead of only having the opportunity to cast a single up-or-down vote. Regular order is worth working toward, since at least one priority we all care about did not fare well in the omnibus.
The omnibus has failed to fund NIH at a level that fully reverses the impact of sequestration on the agency’s baseline funding level, much less establishes a growth trend that can fully unleash the potential inherent in the sequencing of the human genome and other research breakthroughs. As Drs. Paul Stoffels and Alan Leshner make crystal clear in an op-ed in Politico Magazine, we can’t settle for “better than sequestration.” If our nation wants to thrive, we need to grow our investment in science. Between 2010 and 2013, U.S. federal investments in science fell to less than 1% (.82%) of the economy. That’s the lowest it’s been in 50 years! As you know, this comes at a time when foreign nations are rapidly ramping up their R&D programs and taking a page from our playbook. Remember that global competitiveness in medical research is a pivotal determinant of our global economic competitiveness overall. We aren’t just talking about the future of our scientific enterprise, we are talking about the future of our economy. Are we truly willing to cede leadership in global R&D? (See also our statement cited in The Hill and other media outlets, as well as my interview today with UDC.) Continue reading →
We applaud portions of the omnibus bill that support the nation’s research, innovation and public health ecosystem, which works to assure our future health and economic well-being. The growth in funding for the Food and Drug Administration, fueled in part by the common-sense return of the 2013 user fees, as well as the increases for the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality and the National Science Foundation are welcome news.
But funding for the National Institutes of Health has been kept well below the level of scientific opportunity. We must eliminate sequestration once and for all, and grow our investment in NIH in order to slow and halt the progression of diseases and disabilities ranging from Alzheimer’s to diabetes to traumatic brain injury. The appropriators have worked in good faith to move the nation forward. But as long as Congress avoids the primary issues fueling our national debt – tax and entitlement reform – it will be difficult to invest robustly in solutions to our problems.
A Weekly Advocacy Message from Mary Woolley: Pope Francis is the Man of the Year; do you know what the Word of the Year is?
Dear Research Advocate:
Here’s a holiday surprise! I am not referring to the budget deal, but to the fact that Merriam-Webster’s 2013 word of the year — determined via the greatest increase in online searches — is “science.” I find this to be refreshing news, providing evidence that interest in science is growing, which in turn is an indication of substantial room for researchers and research advocates to contribute to public understanding and support of science. We appear to have an opportunity ready for the taking to overcome the “invisibility” problem that contributes to holding decision makers back from assigning a higher priority to science.
And speaking of those decision makers, we have a budget deal! While modest at best, it is a starting point for bipartisanship in serving the public’s interest. We can build on this foundation. Please add your voice, as funding is being determined by appropriators. Click here to urge your Members of Congress to support robust funding for NIH, NSF, FDA, CDC and AHRQ. This week, we’ve released our annual Health R&D Investment report, which could provide new context for your messages. The report shows some gains in philanthropy, industry, and voluntary health association support for research but notes woefully inadequate federal funding, especially given what’s at stake for our health and our economy. Continue reading →
A Weekly Advocacy Message from Mary Woolley: “It always seems impossible until it’s done”– Nelson Mandela
Dear Research Advocate:
As I’m sure you’ve heard, the Joint Budget Committee released a two-year budget agreement Tuesday night. The package involves $63 billion in partial sequestration relief over two years, offset by fees (not taxes!) and a wide variety of cost-sharing arrangements, AKA “pay fors.” While it remains unclear whether user fees will be subjected to any sequester in 2014 and 2015, the already-sequestered FDA user fees are locked up and cannot be used to accelerate medical advances. This is a missed opportunity that patients can’t afford. While not a perfect deal in many respects, the House is expected to approve the Murray-Ryan budget deal within moments, and the Senate is expected to pass it next week.
For the advocacy community, the overall budget number is important, but the appropriations process that follows is crucial. The funding levels for NIH, CDC and AHRQ depend on the funding allocated to the Labor-H subcommittee and the FDA on the Agricultural subcommittee. Since dealmakers have not dealt with tax or entitlement reform, this will involve robbing Peter to pay Paul, and it won’t be pretty. Decisions will be made soon, as Congress is working against a January 15 deadline. Please consider contacting your Members of Congress to urge them to weigh in on how funding is allocated to appropriators and, in short order, allocated by appropriators — ask them to maximize funding for NIH, CDC, AHRQ, FDA and NSF. A report released this week by United for Medical Research, featuring a collection of stories about the negative impact that sequestration has had on NIH as well as the impact on individual research laboratories, can help you make the case. Continue reading →
To protect medical and health research, policy makers must eliminate sequestration. This remains Research!America’s top-line message, because it is sequestration that poses the greatest threat to all discretionary funding, including medical and health research conducted by NIH, CDC, FDA, NSF, AHRQ, DOD … and the list goes on. Advocates for medical and health research have made a huge impact over the years on funding and policies supportive of medical and health research, including playing a key role in reducing sequestration in 2013. We are asking you to weigh in again to help address sequestration in FY14 and FY15.
On Wednesday, the co-chairs of the committee charged with establishing an overall budget number for FY14 struck a deal that would establish this top-line number for both FY14 and FY15. Under this agreement, the sequestration cuts would be reduced by $50-$60 billion over the two-year period (a reduction of approximately 30% each year). While this modest reduction is less than hoped for, it does signal progress in the fight against sequestration. The task now is to assure this or a better deal passes both the House and Senate by December 13.
Please contact your representatives in Congress and urge them to vote in favor of a significant reduction in sequestration for FY14 and FY15 as a down payment on eliminating sequestration.
Take action now.
To address the recent meningitis outbreak at Princeton, public health programs from all levels got involved. Students sought medical attention at the university’s health center and their hometown local hospitals; the New Jersey Department of Health (NJDOH) investigated the outbreak and requested CDC involvement; the FDA examined the case and allowed a new vaccine, unlicensed in the US but approved in Europe and Australia. With final CDC approval, the university will offer the vaccine on campus and cover the cost for all students.
Diverse institutions within our public health infrastructure came together to address the outbreak, and the public health professionals within them did what was needed—as they do in communities across the country. On November 25th, Research!America and other leading health organizations will come together to thank them and all other public health heroes like them. Join us! Connect with us on Facebook (and use #PHTD on Twitter), write to your policymakers, submit a letter to the editor to your local paper (see York Daily Record and Beaufort County Now examples), and more.
Urge your Members to protect medical research in upcoming Budget Conference Committee discussions
Sequestration’s arbitrary, across-the-board budget cuts to defense and non-defense spending have ravaged (and will continue to ravage) our research enterprise. The Budget Conference Committee, which was negotiated as part of reopening the government and preventing the U.S. from defaulting on debts, has an opportunity to replace sequestration as they develop their “long-term budget solution” by December 13. Sequestration is rendering it virtually impossible to maintain, much less increase the budgets of NIH, NSF, FDA, and CDC; if it is not stopped, their budgets will almost certainly decline for the next nine years, regardless of scientific opportunity, public health needs, or the preferences of Americans. Funding cuts are stopping highly promising research in its tracks, squandering exciting new potential for treatments and cures for millions of Americans who are waiting for them.
Deficit reduction is important, but there are ways to achieve it that do not compromise American lives and American competitiveness. Arbitrary budget cuts that abandon medical research are wrong, and it’s time we kicked them to the curb and not down the road!
Take action now.
Bart Peterson, JD, Senior Vice President for Corporate Affairs and Communications at Eli Lilly, and the keynote speaker of the Research!America’s National Research Health Forum talked with Medscape about the future of research and drug development, and whether cooperation between industry and the US Food and Drug Administration (FDA) can ever truly exist. To see the interview, click here.
By Robert J. Hariri, MD, PhD, Chairman, Founder and Chief Scientific Officer of Celgene Cellular Therapeutics.
Medical innovation is the source of dramatic improvements in the quality and length of life and also creates enormous value for society and the economy at large. For example, in 1900, the average U.S. life expectancy was 49 years. Today, it is 79. It is estimated by 2040, U.S. life expectancy will reach 85 years. This is primarily the result of innovation in medicine and improvements to public health. New medical treatments accounted for 45 percent of the increase in U.S. life expectancy between 1960 and 1997 and for nearly three-quarters of the increase in U.S life expectancy in the first decade of the 21st century.
Living longer, healthier lives translates to economic health as well. Economists’ Kevin Murphy, PhD, and Robert Topel, PhD, calculate that life expectancy gains from 1970 to 2000 have added approximately $3.2 trillion per year to national wealth. They also estimate that a 1% reduction in cancer mortality would be worth $500 billion to the U.S. economy.
Unfortunately, there are a number of misconceptions about new medical treatments that are based on outdated information, or failing to consider medical innovation in perspective. One misconception is that prescription drug spending is growing rapidly. In fact, is it not — spending on prescription drugs actually declined by 3.5 percent per capita in the U.S. last year. And the small portion of health care spending accounted for by prescription drugs actually saves money by reducing the need for other medical services. Continue reading →
Research!America’s National Health Research Forum — held September 12 at the Newseum’s Knight Conference Center in Washington, DC — examined the current and future state of research to improve health. This year’s theme was “Straight Talk about the Future of Medical and Health Research.” Three expert panels delved into different aspects of the research ecosystem.
Research!America’s president and CEO, Mary Woolley, and chair, The Honorable John Edward Porter, opened the program. Porter introduced Bart Peterson, JD, senior vice president of corporate affairs and communications at Lilly who delivered a brief keynote speech.
“We developed an innovation ecosystem, and that ecosystem requires sound public policy. From the private sector perspective, that includes solid intellectual property protection; a fair, rigorous, transparent regulatory system; a market system of health care delivery and pricing that offers choice for patients and health care providers,” Peterson said. “But the public sector has a role far beyond just producing sound public policy … Public funding for research, which is so threatened today, is absolutely critical to the future and we care about that as much from the private sector perspective as anybody else does.”
The first panel, focusing on biomedical research and development, was moderated by journalist Eleanor Clift of Newsweek and the Daily Beast and featured John Crowley, president and CEO of Amicus Therapeutics and a patient advocate; William Hait, MD, PhD, global head of R&D at Janssen Pharmaceuticals; Margaret Hamburg, MD, commissioner of the Food and Drug Administration (FDA); and Peterson. The discussion centered on innovation within the pharmaceutical industry and the relationship between companies and regulators. Continue reading →
Dear Research Advocate:
Although Congress officially returns next week, many Members are back in Washington as the debate about the crisis in Syria commands center stage. Members also face looming fiscal deadlines, with only nine legislative days scheduled in September to act on those and a large backlog of other legislation. Given all this, it is not hard to predict how Congress will handle the long- or short-term budget resolutions, debt ceiling, the future of sequestration, tax and entitlement reform, and a myriad of other interconnected items: They will put off decision-making.
Thus a continuing resolution (“CR”), extending FY13 budgets, looks likely, once again kicking the can down the road and, in doing so, kicking patients and researchers alike into the ditch. And things will be worse than the terrible FY13 numbers, given that the Budget Control Act mandates less discretionary spending in FY14 than in FY13 — almost certainly prompting agencies to further decrease their spending while waiting for what might well be a still-lower final appropriations bill (more details here.)
This adds up to “a dark future for science” according to NIH Director Francis Collins. He and other leaders of science believe that the nation is increasingly underprepared to meet existing — not to mention emerging — health threats. Now is the time to hold Congress accountable for avoiding a dark future by making your voice heard. Click here to send a message to your representatives that medical research at NIH, CDC and our other health research agencies must be championed in the upcoming fiscal debates — not cut, not put on hold, but prioritized, championed. After participating online, magnify your voice as a broad coalition joins forces on September 18 to participate in the American Association for Cancer Research’s Hill Day, urging Congress to champion the National Institutes of Health. Continue reading →