FDA

Dear Research Advocate: So much is troubling our nation – evidenced in protests of recent grand jury decisions and the controversy over release of the Senate’s report on the CIA – that most people probably haven’t noticed or cared that the Congress is delaying and may even abort action on the long overdue funding of the federal fiscal year that began on Oct. 1. People have grown tired of Congress missing self-imposed deadlines, only to say they can only act in the face of those deadlines, and now they are talking of doing it again. And thus we are lulled into thinking it doesn’t matter what the Congress does. But that would be wrong: priority-setting by the Congress plays a major role in...
The tiny increases included in the “Cromnibus” bill for the National Institutes of Health (NIH) and our nation’s other health research agencies are just that. The underwhelming support for the NIH, the Centers for Disease Control and Prevention, the National Science Foundation and the Food and Drug Administration following years of stagnant funding and budget cuts begs the question – how low can we go, given health threats the likes of which stand to bankrupt the nation? And the decision to flat-fund the Agency for Healthcare Research and Quality does not provide what it takes to reduce the much-complained of inefficiencies in our health care system. The pain and economic drain of one...
Dear Research Advocate: As I write, most members of Congress are on the way home for August recess. As anticipated, no further action has been taken on the appropriations front ’€“ or much else, for that matter. In terms of issues we care about: no movement on tax reform, which means no much-needed enhancement of the research and development tax credit; no repeal of the medical device tax; and no final passage of Fiscal Year 2015 appropriations bills. In upcoming letters I will talk in more detail about Capitol Hill-focused advocacy strategies through the election and beyond. In the absence of legislative action, some attention ’€“ in a bipartisan manner ’€“ is being given to research for...
Is the patient voice adequately represented in the drug development process? The situation has improved but the patient community is not yet recognized as a co-equal in drug development or regulatory review according to Marc Boutin, executive vice president and chief operating officer at the National Health Council , a panelist at a BIO International Convention session on Wednesday. ’€œWe scare you,’€ declares Boutin who says there is an adversarial connection between patients, regulators and industry but the relationship has evolved over the last decade. Patient advocates have developed strategies to amplify their voice and demand access, providing the data and evidence to help transform...
Maximizing the return on investment in quality innovation was the topic of a BIO International Convention Super Session on Tuesday which explored challenges and opportunities for pharmaceutical companies in improving efficiencies and ensuring patient safety. Panelist Martin VanTrieste, Senior Vice President, Quality, Amgen described a global initiative formed by industry and regulators to share knowledge and best practices that will help secure the pharmaceutical supply chain and quality of materials. Rx-360, a consortium of pharmaceutical companies, suppliers and regulatory agencies, is tasked with developing voluntary standards for the quality and authenticity of supplies and suppliers,...
Federally-funded research projects that have advanced medical innovation will be on full display at the BIO International Convention Innovation Zone June 23 ’€“ 26 in San Diego. Among the new technologies, a device to prevent secondary cataract formation developed with a National Institutes of Health SBIR grant awarded to Sharklet Technologies , Inc. Secondary cataract, a serious complication of cataract surgery, occurs in 25% to 50% of patients. This complication requires a follow-up laser treatment which presents an additional risk to patients and adds more than $300 million in medical costs per year in the U.S. The novel device, a micro-patterned membrane designed to be integrated into a...
Dear Research Advocate: Today, Chairwoman Barbara Mikulski (D-MD) released the Senate’€™s 302(b) allocations , which were approved by the Appropriations Committee. As you know from last week, the House 302(b) allocation for the Labor-HHS subcommittee is approximately $1 billion less in fiscal year 2015 than it was in FY 14.The Senate’€™s allocation for FY 15 is roughly the same as it was in FY 14. The bottom line is that, as expected, we have our work cut out for us to achieve the increases needed for the National Institutes of Health (NIH) and our nation’€™s other health research agencies. Fortunately, Senator Mikulski and other leaders from both sides of the aisle understand the...
Dear Research Advocate: Congress continues to pay particular attention to – and make decisions bearing on – the pace of medical progress. To briefly count the ways: The Senate Labor-HHS Appropriations subcommittee heard testimony yesterday from agency heads within HHS about the significance of health-related spending, including spending on medical and health research. Read our written testimony here . Congressman Upton (R-MI-06), the Chair of the House Energy and Commerce Committee (which has jurisdiction over authorizing legislation for NIH, CDC, FDA and AHRQ) and Congresswoman Diana DeGette (D-CO-01), a member of the Committee, launched their 21st Century Cures initiative with a...
Dear Research Advocate: There is still time ’€” if you act quickly ’€” to urge your representative to sign on to the House letter authored by Representatives McKinley (R-WV-01), Davis (D-CA-53), Carson (D-IN-07) and King (R-NY-02) urging more support for NIH ’€” it will be finalized by close of business today. A similar Senate letter, authored by Senators Casey (D-PA) and Burr (R-NC), will be finalized Tuesday, April 1; ask your senators to sign on today! An appropriations mechanism known as a “tap” made the news Tuesday when, during a hearing on NIH, Members of Congress asked advocates questions about the use of a tap by the Department of Health and Human Services (HHS) to move money from...
The House and the Senate have begun deliberations on funding levels for NIH, CDC, AHRQ, NSF and FDA for FY15. Pressure to cut federal spending this midterm election year is enormous, and we need advocates to reach out to their representatives. Members in both houses of Congress are accepting input from constituents on which priorities they should fight for. Let your representatives know that combating disabling and deadly diseases is a national imperative, and funding for the agencies committed to this fight should be included on their list of appropriations priorities. Contact them TODAY and share this alert on Facebook, Twitter and with your networks. Take action!

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Funding research gives all of us a better chance of living a healthier life.
Pam Hirata, heart disease survivor