FDA

The Food and Drug Administration, the oldest comprehensive consumer protection agency in the U.S. federal government, is charged with protecting the public health. Under this mandate, it regulates drugs and medical devices for their safety and effectiveness. But is it a failing mandate? It’€™s been argued that the FDA’€™s long and costly approval processes stifle innovation and keep life-changing treatments from the market. When it comes to public health, is it ever OK to sacrifice safety for speed? Research!America has asked that same question in polling over the years; most recently in August 2012 . We asked 1,052 likely voters whether FDA should move more quickly despite the risks or...
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,...
Dear Research Advocate, Glimmers of hope can be found in the dire funding situation we face under sequestration. The continuing resolution (C.R.) funding the government through the end of the fiscal year (September 30) included very small increases for NIH, CDC, NSF and FDA; AHRQ was flat funded. But the fact remains that these increases were overwhelmed by the effect of sequestration, which remains in place and will continue to weigh us down for 10 years unless overturned. Our champions in Congress are speaking out and taking a stand on behalf of research as the budget negotiation proceeds. Reps. McKinley (R-WV) and Markey (D-MA) have co-authored a letter to House appropriators calling for...
Sequestration will have a devastating impact on biomedical research and public health in the U.S. Learn more about the effects of sequestration ’€” 10 years of across-the-board spending cuts for federal agencies including the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Science Foundation ’€” on our website . We encourage you to use this information as you continue to advocate for medical research and join us as we fight to reverse sequestration. The Honorable John Edward Porter, chair of Research!America, sat down recently with Kellye Lynn of ’€œComcast Newsmakers’€ to discuss sequestration and why such...
The Rally for Medical Research will be held on Monday, April 8 at 11:00 a.m. in Washington, DC, on the steps of the Carnegie Library. Join Research!America and more than 100 other organizations to call on our nation’€™s policymakers to make lifesaving medical research a higher national priority. With the support of researchers, patients and advocates, the Rally for Medical Research is a tremendous opportunity to send a powerful, coordinated message to Capitol Hill. If you can’€™t make it to DC for the Rally, you can take specific actions on April 8 such as: Send an email to or call congressional offices, Tweet members of Congress with a message or post on the member’€™s Facebook page, Write...
Dear Research Advocate, Congress has passed a spending bill for what remains of the current fiscal year, which ends September 30. Preliminary agency funding levels have been reported by Nature . The appropriations process remains important for making up some small amount of the ground lost to sequestration, but as long as sequestration remains the law of the land, annual cuts to NIH, FDA and our nation’€™s other health research agencies are all but assured ; and with it, the insidious ripple effect of damage to grantees, vendors, and the pharma, bio and device industries that partner with researchers to develop the products patients await. That’€™s the bottom line. We must remind our...
Dear Research Advocate, Yesterday, the House passed a budget for the remainder of the fiscal year that includes this year’€™s cuts from sequestration along with an additional one percent across-the-board cut. The bill now heads to the Senate for consideration, where we are likely to see higher funding levels than the House version, but with sequestration still in place. Congress seems anxious to avoid the brinksmanship and the government shutdown threats that have characterized past debates. While the less rancorous environment surrounding the CR is a welcome change, the complacency around sequestration is not. As research advocates, we cannot let these cuts stand. Sequestration isn’€™t a...
Just released data from the White House Office of Management and Budget (OMB) details the final amount to be cut from federal research program budgets as sequestration goes into effect. The full details are available on the updated Research!America sequestration fact sheet , though previous projections were relatively accurate as compared to these final numbers. Cuts to the Centers for Disease Control and Prevention and the Food and Drug Administration will be higher than previously expected, with a combined loss of $593 million dollars for FY13. That amount is roughly equivalent to ensuring the safety of new medical and biological products at the FDA and programs that focus on prevention...
It’€™s all over the news: The federal government is headed for significant, across-the-board budget cuts. Sequestration, or 10 years of automatic spending cuts, is a self-inflicted consequence passed by Congress, aimed to be a drastic outcome of failing to agree on a federal deficit-reduction package. Some Members of Congress argue that the sequester will not have a significant impact; they claim that the 5.1% cuts made in 2013 are only a drop in the bucket and there is no need to worry. However, the amount of money that the National Institutes of Health will lose, $1.56 billion, could fund the entire National Institute of Mental Health for more than a year. Cuts to the National Science...
This week, Boston Mayor Thomas M. Menino declared a public health emergency in the city due to a flu outbreak. City officials have confirmed 700 cases of the flu, nearly ten times the confirmed cases last year; four people have died so far. Outbreaks have been reported in other areas of the country, affecting individuals of all ages and backgrounds. The Centers for Disease Control and Prevention recommends that the best way to prevent the flu is by getting vaccinated each year. It’€™s hard to imagine the dire health consequences Americans would endure without the flu vaccine, which is due in part to federal investments in research. The CDC and the Food and Drug Administration have made...

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