FDA

Dear Research Advocate: Advocacy works. More members of Congress are speaking out in support of research, including at a Senate Labor-H Appropriations Subcommittee hearing featuring testimony from NIH Director Francis Collins and several NIH Institute Directors. Appropriations Committee Vice-Chairwoman Barbara Mikulski (D-MD) summed up the limitations created by the sequestration caps succinctly: “We cannot cap innovation, we cannot cap breakthroughs.” Labor-H Subcommittee Chairman Roy Blunt (R-MO) underscored the point that both the subcommittee and full appropriations committee support biomedical research as a high priority. The subcommittee’s Ranking Member Patty Murray (D-WA) spoke of...
Could a 21 st Century Cures bill that modernizes the research ecosystem cross the finish line in Congress in the near future? We’re moving in the right direction, according to most of the panelists featured in POLITICO Pro’s “How Fast to Cures?” discussion on October 7, 2015 at the Newseum in Washington D.C. “For the first time in decades, with the House bill of 21 st Century Cures and with the Senate companion piece that they are working on, we’re seeing a revving up of our full ecosystem of discovery, development and delivery of medical progress that incorporates the patient community in ways that we’ve never seen,” said Mary Woolley, president and CEO, Research!America. Advocates should...
Dear Research Advocate: Pope Francis’ visit to Washington has been a breath of fresh air, but now Congress must get to work and reach a funding agreement that avoids a government shutdown beginning October 1st. Didn’t we learn from the last shutdown, just two years ago? Young patients were turned away from clinical trials at NIH. Disease outbreaks were not monitored because CDC epidemiologists were furloughed. Drugs, devices and other medical products pending FDA approval were delayed. All of this -- and much, much more -- was then and is now, entirely avoidable. Advocates should not be complacent; a government shutdown screams “broken government,” and should not even be on the table...
Dear Research Advocate, Throughout its 26-year history, Research!America has been fortunate to attract extraordinarily gifted and dedicated national leaders to its Board of Directors. One such leader, the Honorable Louis Stokes, passed away on Tuesday . A powerhouse lawyer, founding member of the Congressional Black Caucus, skilled appropriator, and able chair of the House Ethics Committee, Lou was also a stalwart advocate for medical research and promoted efforts to address health disparities; in so many ways, Lou created a better future for all of us. Our fight for medical progress is, and will continue to be, part of his legacy. Current board member Dr. Herb Pardes wrote a compelling...
Strange bedfellows? Not when it comes to research advocacy. On Monday, former House Speaker Newt Gingrich joined Senator Elizabeth Warren (D-MA) and Representative Elijah Cummings (D-MD-07) to press for more R&D in the bioscience arena. Not every topic is one on which Senator Warren and Speaker Gingrich agree , but they found common ground in the benefits that could come from another NIH doubling. The drumbeat for medical research continues apace. The Bipartisan Policy Center (BPC) released what is sure to be an influential report this week, Advancing Medical Innovation for a Healthier America . Focused on the development phase of the discovery, development, delivery continuum, the...
Dear Research Advocate: Congress has postponed further action on patent reform. Concern over provisions in the legislation poured in from a broad coalition within the life sciences community, including universities, patient advocates, and the pharmaceutical and biotech industries. BIO’s Jim Greenwood and PhRMA’s John Castellani penned a compelling op-ed on the topic for The Hill . Now there is more work to be done as policymakers and advocates continue the conversation about reforming our nation’s patent system. Stay tuned. Momentum for a two-year extension of the R&D tax credit is building in the Senate. The Senate Finance Committee, spearheaded by Senator Orrin Hatch (R-UT), voted...
Dear Research Advocate, The “moment” for research that we’ve been experiencing on Capitol Hill is being echoed by Presidential candidates; is this perhaps the start of a wave of conversation on the campaign trail? On Tuesday, the Senate Commerce Committee, which is not the committee of jurisdiction for NIH or FDA, or intellectual property, held a hearing on these very topics. Committee Chairman and Presidential candidate Ted Cruz (R-TX) framed the hearing as an opportunity to explore strategies for speeding cures to patients. The hearing might have devolved into an “FDA regulation is bad” fest, and to be honest there was some of that, but the Senators present, along with the witnesses,...
I am sending my letter early this Thursday to give readers who support the NIH and FDA funding in the 21st Century Cures Act -- most of you, based on the emails and calls I’ve been receiving -- a little more time to take action. The House is slated to vote on the 21st Century Cures Act (HR 6) tomorrow. As part of the process they will first vote on amendments, including one offered by Congressman Dave Brat (R-VA-07) to eliminate the $8.75 billion in mandatory funding for NIH and $550 million for FDA. I can’t stress the importance of stopping this amendment strongly enough: opportunities like this to fund significantly more research do not present themselves often.This is $8.75 billion for...
Dear Research Advocate, This just in--the final version of the 21st Century Cures Act has been filed with the House Rules Committee in anticipation of a House vote next week. And to understate the news: it’s great!! The bill contains mandatory funding of $8.75 billion for the NIH Innovation Fund and $550 million for FDA. Compared to the version that passed the Energy and Commerce Committee, that’s $1.25 billion less for the Innovation Fund over five years. But considering what Reps. Upton (R-MI-06) and DeGette (D-CO-01) were up against in securing this supplemental funding stream, and thinking about what these dollars could mean for medical progress, the end result is a HUGE victory. Click...
A global solution and removing barriers to antibiotic development are necessary to combat antimicrobial resistance (AMR). Representatives from various research and health sectors discussed strategies for fighting superbugs at a BIO International Convention super session today. The panel agreed there must be a greater focus on streamlining clinical trials and harmonizing the global regulatory process to support the development of new antibiotics. Jim O'Neill, chairman, Review on Antimicrobial Resistance, recommended the establishment of a global $2 billion AMR Innovation Fund over five years funded by industry to help jump start product development. Venture capitalist risk could stimulate...

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