FDA

Dear Research Advocate, The 2016 21st Century Cures Act (21stCC) is a prime example of patient groups, government, the private sector, academia and other research stakeholders working together toward a common goal: accelerating medical progress. With new thinking and new funding, 21stCC has empowered our nation to work more quickly to address rare diseases and chart new territory in areas such as regenerative medicine and brain science. (And that’s just scratching the surface.) We can’t overstate the credit due the policymakers spearheading 21stCC for their leadership, commitment and determination. Now the same team — Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) — is working...
Dear Research Advocate, On the Monday before Thanksgiving each year, Research!America, along with public health leaders across the nation take time to salute the people who work day-in and day-out to protect us from disease, injury, and other threats to our nation’s health. Members of this critical workforce can be found in every community across the country. They track infectious diseases and administer the vaccines to prevent their spread. They warn us about overuse of antibiotics leading to drug-resistant infections. They educate us about preventing accidental deaths by using infant car seats and about newer but avoidable dangers like vaping. And more. The public health workforce...
Dear Research Advocate, This week was chock-full of federal appropriations activity bearing on the future of research, and ultimately, the future of health. While agency funding for Fiscal Year 2020 is far from resolved, some very positive and not-so-positive steps were taken by Congress. First, the Senate Appropriations Committee released its long-awaited Labor/HHS bill. The exciting headline is that NIH received a vital $3 billion increase, which, if enacted, would bring its total funding to $42.08 billion. The CDC, meanwhile, would receive an increase of only $180 million for a total budget of $7.46 billion. This increase is woefully insufficient to enable CDC’s 24/7 vigilance and...
Dear Research Advocate, I’m writing early this week to remind those of you who won’t be joining us in person that you can join our National Research Forum tomorrow, Thursday, via livestream. See more information at the end of this letter. Political theater isn’t everyone’s cup of tea, but I have always enjoyed it, from the Greeks to Hamilton. A remarkable, multiple-award-winning play, “What the Constitution Means to Me” will open soon at the Kennedy Center after a successful run on Broadway, and will soon head to the West Coast. I highly recommend it. Written several years ago by Heidi Schreck, who is also the lead, the work brings out the good news – and the complicated and ever-evolving...
A total of “1.7 million Americans will receive a new cancer diagnosis this year,” announced Frederick Ryan , President, and CEO of The Washington Post , in his opening remarks for the Post’s Chasing Cancer event earlier this month. Sponsored by Tesaro and the George Washington Cancer Center, the event did not shy away from difficult topic matter. Still, there were bright spots. “Why does cancer seem to work better in terms of novel therapeutic discoveries than other areas?” Asked new Acting FDA Commissioner Ned Sharpless . He believes it’s in part because researchers have a “good biologic understanding of the problem,” something that may be lacking when it comes to other conditions. The “...
Dear Research Advocate, The House Labor-HHS Appropriations Subcommittee markup of Fiscal Year 2020 spending priorities on Tuesday featured lots of good news. You can watch the subcommittee’s deliberations here and find draft text of the bill here . The next stop is consideration by the full Appropriations Committee on May 8, 2019. Some highlights: $41.1 billion for the National Institutes of Health, an increase of $2 billion above last year; $8.3 billion for the Centers for Disease Control and Prevention, $921 million above the 2019 enacted level, including new funding for efforts to support modernization of public health data systems (for example, to track and prevent the spread of...
Dear Research Advocate, I am very pleased to announce that Research!America’s 2020 Advocacy Awards nominations are now open! Act now to nominate those you want to recognize for outstanding advocacy leadership on behalf of scientific, medical, or public health research. The awards will be presented at our dinner next March. When members of Congress return to Washington, D.C. next week, the House will begin considering Fiscal Year (FY) 2020 appropriations bills, with the Labor-HHS Subcommittee scheduled to mark up their bill on April 30. Trust for America’s Health (TFAH) has released a new report explaining why our nation needs a well-resourced public health system (which pivots on a well-...
Dear Research Advocate: As you know, there has been a cease fire in the shutdown and people are back to work, at least for now. Over the next two weeks, members of Congress will attempt to resolve the stalemate over funding for the President’s border wall, packaging it with the seven remaining FY 2019 spending bills, which include funding for the Food and Drug Administration (FDA) and the National Science Foundation (NSF). I am feeling optimistic about a deal being struck, not least because Sen. Richard Shelby (R-AL), Chairman of the Senate Appropriations Committee, and Representative Nita Lowey (D-NY), Chairwoman of the House Appropriations Committee, are leading the congressional...
Dear Research Advocate, The partial government shutdown continues, now at day 27. There are too many furloughed workers struggling to make ends meet, our nation’s parks and monuments are being ruined, research support by NSF has been put on hold, and drug approvals have slowed at FDA. For a run-down on the broadscale impact, see this USA Today article quoting ASBMB’s Ben Corb, and for a closer look at the toll the shutdown is taking on research, check out this article discussing the impact at the University of Wisconsin, emblematic of so many campuses nationwide. As a temporary patch, agency leaders have called back thousands of employees to work without pay. At the FDA, Commissioner Scott...
Dear Research Advocate: The government remains in a partial shutdown that began on December 22, taking a mounting toll on 800,000 federal workers, including those at FDA and NSF. The Alliance for a Stronger FDA has put together a “ Shutdown Toolkit ” detailing how this ongoing impasse is affecting us all. In a similar vein, the Coalition for National Science Funding has been sharing stories on social media that focus on how the shutdown is impacting NSF-funded research and programs, stifling discovery and sending a message of ‘no public confidence’ to aspiring young scientists. Clearly, the effects of the shutdown on research are multiple, disruptive and counterproductive. This New York...

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If concerted, long-term investments in research are not made, America will lose an entire generation of young scientists.
Brenda Canine, PhD; McLaughlin Research Institute, Montana