FDA

by Mary Woolley, Research!America President and CEO. This entry was originally posted as a guest contribution to PhRMA’€™s Conversations forum. A shift in attitude among elected officials is necessary if this nation is to succeed in combating disease and stemming the rise of health care costs. Federal funding for the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and other agencies that conduct medical and health research has not kept pace with scientific opportunity, jeopardizing our ability to find cures for deadly disease and to maintain our global competitive edge. Medical research has not risen to the upper ranks of our nation’€™s priorities in the halls...
The Food and Drug Administration announced Friday that it is proposing to establish a maximum level of arsenic acceptable in apple juice. The threshold, 10 parts per billion, is the same as the Environmental Protection Agency’€™s requirement for drinking water. The agency will accept public comments on the proposed action for 60 days. Nearly two years ago, reports from the TV show of Mehmet Oz, MD, and later Consumer Reports , raised alarms about the amount of arsenic appearing in apple juice. The FDA’€™s own subsequent investigation found that overall arsenic levels were generally below the 10 ppb threshold. Of those that were higher, the levels of inorganic arsenic ’€” identified as a...
The Food and Drug Administration announced Friday that it is proposing to establish a maximum level of arsenic acceptable in apple juice. The threshold, 10 parts per billion, is the same as the Environmental Protection Agency’€™s requirement for drinking water. The agency will accept public comments on the proposed action for 60 days. Nearly two years ago, reports from the TV show of Mehmet Oz, MD, and later Consumer Reports , raised alarms about the amount of arsenic appearing in apple juice. The FDA’€™s own subsequent investigation found that overall arsenic levels were generally below the 10 ppb threshold. Of those that were higher, the levels of inorganic arsenic ’€” identified as a...
Dear Research Advocate: Yesterday, I joined Diane Rehm and other guests on her nationally syndicated radio program to discuss how sequestration impacts “ordinary Americans.” I was struck by how deep and distressing the damage is, in so many sectors, including but not limited to our own. Yet somehow the pain is not acute enough to force action. What strikes me is how low our collective expectations have sunk when it comes to reinvigorating U.S. economic growth and prosperity. Our nation can do better; why don’€™t we maintain high expectations and hold our elected officials accountable for setting the policy stage to accomplish them? Policy makers should protect discretionary spending, make...
By Olivera J. Finn and Robert E. Schoen An excerpt of an op-ed by Olivera J. Finn, PhD a distinguished professor and chair of immunology at the University of Pittsburgh School of Medicine and Robert E. Schoen, MD, MPH professor of medicine and epidemiology at Pitt’s School of Medicine and Graduate School of Public Health published in the Pittsburgh Post-Gazette . Olivera J. Finn, PhD Robert E. Schoen, MD, MPH Every day, physicians and scientists see the hope and promise that medical research brings to patients and families. For nearly 70 years, research funded by the National Institutes of Health has increased understanding of the causes of disease, contributed to longer life expectancy and...
Dear Research Advocate: On Wednesday, the House Appropriations agriculture subcommittee approved the funding bill that includes the Food and Drug Administration. The bill allocates nearly $100 million above the post-sequester levels. Unfortunately, the baseline budgets in the House are so low that this increase is still lower than FY12 FDA funding. We must not fall into the trap of lowering our expectations and applauding an artificial victory. The true mark of success is funding that keeps up with need. We must keep working. As demonstrated particularly by the 18.6% cut targeted for the House LHHS appropriations FY14 budget, the pressure to shrink government by slashing discretionary...
Dear Research Advocate: I invite you to join me in speaking out during the Memorial Day congressional recess (May 27-31) as part of a social media campaign using the hashtag #curesnotcuts. Our goal is to continue to position research and innovation to improve health where it belongs: as a fundamental national priority that Americans can count on because their elected representatives rank it so highly. In our social media campaign, each day of the recess has a specific theme that can be customized with your information and patient/researcher stories. We have made it easy to get involved: click here to see sample social media messages, a list of selected congressional offices and their...
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...

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