FDA

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!
Dear Research Advocate: The president’€™s budget for FY15 was released Tuesday. While mostly symbolic, the president’€™s funding recommendations often serve as the ’€œfirst bid’€ in the negotiations that result in agency funding levels. That is why the president’€™s proposals for the agencies that collectively drive medical progress and play such a pivotal role in the health and safety of Americans are of such concern. The president’€™s budget proposes only slight increases for NIH, FDA and NSF in FY15, and significant cuts for CDC and AHRQ. As I said in The Huffington Post and in other media, President Obama’€™s budget does not reflect the potential the U.S. has to advance scientific...
The president’€™s budget does not reflect the potential the U.S. has to advance scientific discovery. While welcome, the minor increases for the National Institutes of Health, the National Science Foundation, and the Food and Drug Administration diminish our ability to accelerate the pace of medical innovation, which saves countless lives, helps our nation meet its solemn commitment to wounded warriors, and is a major driver of new businesses and jobs. We’€™re also disappointed with reduced funding for the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention. AHRQ and CDC cannot be neglected in the name of deficit reduction, and it is truly...
The last day in February marks the annual International Rare Disease Day , first celebrated in 2008 by European coordinators the European Organization for Rare Diseases (EURORDIS). For the past five years, the United States has participated in this effort thanks to the hard work of the National Organization for Rare Disorders (NORD) and other committed alliances and patient advocacy groups. Rare diseases are classified in the U.S. as illnesses affecting fewer than 200,000 individuals ’€“ about 0.005% of Americans. These patients and their families often struggle to be heard and there are major gaps in research on treatments and cures due to the small percentage of the population impacted by...

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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