FDA

Dear Research Advocate, This holiday season, Congress has delivered a most welcome package with plenty of trimmings for patients and all of us who care about the future of health. The bipartisan deal-making is complete. A final short-term spending measure, expiring Tuesday, December 22, allows the House and Senate time to review and pass a spending bill and tax package before adjourning for the year. These two major pieces of legislation represent a real win for research; the jumpstart we need to restore the NIH budget to robust annual growth and fuel a new era of medical innovation and global leadership in both public and private sectors. As federal policymakers consider how to vote on...
Dear Research Advocate, The current continuing resolution (CR) expires tomorrow. Congress has yet to reach agreement on FY16 appropriations, so they will buy more time to hammer out a funding package by passing another CR lasting til midnight Wednesday, December 16. The major sticking points at this moment are additional policy riders attached to the funding omnibus, spanning the spectrum from immigration and refugees to labor and environmental issues. As it looks right now, some research-related budgets stand to gain, while others face a less positive fate. There’s more on NIH in my interview with The Atlantic , and we continue to press for increases for CDC, FDA, AHRQ and NSF. Social,...
Over the course of his last few weeks before retiring, Speaker Boehner worked with fellow House and Senate leaders and the President to fashion a budget deal that increases the nation’s debt limit and provides an additional $80 billion above sequestration-level spending caps. Both non-defense and defense programs will receive $25 billion more in fiscal year 2016 (FY16) and $15 billion more in FY 2017. The House has passed this budget plan, and the Senate is expected to follow suit by Tuesday. See our statement . Passing this deal is step one. Step two is allocating top-line budget numbers across the 12 appropriations subcommittees (these allocations are known as “302(b)s”). This will likely...
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,...

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The capabilities are enormous, a little bit of research can pay off quite a bit in the long run.
Paul D’ Addario, retinitis pigmentosa patient