FDA

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...
Technology transfer, or the practice of transferring scientific findings from one organization, most notably universities, to another for further development, plays a pivotal role in the R&D ecosystem. It is the bridge that ensures knowledge cultivated through academic research reaches patients and other beneficiaries, and it is a critically important means of financing further science and technology at academic institutions in the U.S. and around the world. The Association of University Technology Managers (AUTM), a nonprofit organization with an international membership of more than 3,000 technology managers and business executives, has developed a project that not only highlights the...
Scientific research is advancing the frontiers of knowledge with discoveries that will ultimately lead to the eradication of life-threatening conditions. Translating discoveries into safe and effective treatments for patients, however, requires robust investments, collaboration and the support of a modernized regulatory system. “When our laws don’t keep pace with innovation, we all lose,” said Representative Fred Upton (R-MI-06), chair of the House Energy and Commerce Committee. Rep. Upton and Rep. Diana DeGette (D-CO-01) are spearheading the 21 st Century Cures Act which aims to accelerate the pace of medical innovation from discovery, development to delivery. During the upcoming BIO...
The serendipitous discovery of penicillin by Alexander Fleming in 1928 transformed the course of modern medicine. Penicillin, followed by a series of other antibiotics, seemed to promise a world free of infectious diseases that once killed millions of people worldwide. Medical breakthroughs such as organ transplants and chemotherapy would not have been possible without the development of antimicrobials. Fleming warned, however, that microbes have the ability to, and inevitably will, develop resistance to antibiotics. It did not take long to prove him right, with drug-resistant strains appearing just within years after the introduction of penicillin, as was the case for many subsequent...
Dear Research Advocate, I am pleased to repeat myself when I report that it’s been another science-heavy week on Capitol Hill...and most, but not all, of the news is good. This morning, the Energy and Commerce Committee passed (51-0, a tremendous bipartisan victory) the 21st Century Cures Act with new mandatory funding for FDA, and with the NIH Innovation fund intact...and both are paid for! Representatives Upton (R-MI-06) and DeGette (D-CO-01) kept their word and managed, in an extraordinarily tight fiscal environment, to negotiate viable supplemental funding for federal agencies pivotal to medical progress. I am not saying the bill is perfect, nor arguing that stakeholders should support...

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You can change the image of things to come. But you can’t do it sitting on your hands … The science community should reach out to Congress and build bridges.
The Honorable John E. Porter