• Senator Looks to Spur Development of Medicines Through 'Prize Fund'

    • 15 May 2012
    A Senate hearing being held by Senator Bernie Sanders (I-VT) seeks to advance legislation that would create a prize fund for companies to create new medicines and vaccines, partially replacing the current market-exclusivity model of product development. Sanders' legislation, S.1137: The Medical Innovation Prize Fund Act , was introduced in May 2011, but has thus far eluded much notice. In remarks on the Senate floor on 15 May, Sanders said he did not expect the bill...
  • Brazil: Regulation To Foster Innovation

    Brazil's reorganized national regulatory agency, Anvisa, said in remarks it is focused on establishing "a  regulatory environment conducive to innovation." The remarks, by Anvisa's CEO Dirceu Barbano, were made at the opening of the First Week of Sanitary Surveillance in Congress on 8 May.   The regulatory framework for innovation support will be based on "stability, predictability, clarity, rationality and efficiency," explained Barbano.   Innovat...
  • Hamburg Touts FDA's Promotion of a 'Robust Field of Regulatory Science' in Speech

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg touted her agency's efforts to advance and promote a 'robust field of regulatory science' in a speech before a NEHI Conference. Calling regulatory science "important," Hamburg laid out some of what FDA has managed to accomplish in the last few years, including the establishment of three Centers of Excellence in Regulatory Science, working to get the Reagan-Udall Foundation up and running and the format...
  • BIO Head Calls for New Position to be Formed at FDA to Boost Innovation

    The head of the Biotechnology Industry Organization (BIO), the leading trade group for biotechnology and biopharmaceutical organizations in the US, called on the US Food and Drug Administration (FDA) to make room in its organizational structure for a Chief Innovation Office (CIO), reports The Boston Business Journal . Speaking at the organization's annual meeting in Boston, BIO President and CEO James Greenwood said FDA has a duty to go beyond its mission to protect con...
  • Castellani Says PhRMA Looking to Uphold Affordable Care Act to Protect Regulatory Pathway

    • 13 April 2012
    The Pharmaceutical Research and Manufacturers of America was an early-and controversial - supporter of the Patient Protection and Affordable Care Act (PPACA) when the legislation was being formulated. Now under the tutelage of President John Castellani, the group says it is looking to keep the legislation in place, reports Market Watch . The loss of a regulatory pathway for approving biosimilar products, said Castellani, would be a disastrous setback. Likewise a num...
  • Device Innovation Pathway Tackles End-stage Kidney Disease

    The US Food and Drug Administration (FDA) has selected three medical devices being developed for end-stage kidney disease for participation in its new Innovation Pathway , which provides the sponsors of the devices the opportunity to work collaboratively with the agency.  The goal of the Pathway is to reduce the time and cost of bringing safe and effective, breakthrough devices to patients. The three devices selected for the end-stage kidney disease initiative are:...
  • FDA Opens Innovation Pathway to First Round of Devices

    The US Food and Drug Administration (FDA) is announcing its intention to open up its experimental Innovation Pathway to three medical device companies developing therapies for end stage renal disease (ESRD). FDA's 9 April announcement said the three organizations-CreatiVasc Medical, Blood Purification Technologies Inc. and the University of California-were among 32 product applications covering a wide range of applications.  "The response from innovators exceeded...
  • Bill Looks to Make Changes to FDA's Accelerated Approval Pathway

    • 05 April 2012
    A new piece of legislation released in discussion draft form by the Senate Health, Education, Labor and Pensions Committee aims to "overhaul" the US Food and Drug Administration's (FDA) Accelerated Approval pathways, reports The Hill . Among other things, the bill would "create a new 'breakthrough' designation to provide more flexibility and certainty for developers of new medicines intended to address serious or life-threatening diseases or conditions," reports The Hi...
  • Senators Draft Bill to Expedite Drug Approval

    A piece of legislation introduced this week by a bipartisan group of three Senators would "expedite US Food and Drug Administration (FDA) approval and provide more flexibility when a drug or treatment shows dramatic responses early in development, while still ensuring drug safety and efficacy," according to the Senators. Sens. Michael Bennet (D-CO), Richard Burr (R-NC) and Orrin Hatch (R-UT) introduced the Advancing Breakthrough Therapies for Patients Act (ABTPA) on ...
  • FDA Looking to New Paradigms for Getting Drugs to Patients More Quickly

    The US Food and Drug Administration (FDA) is evaluating whether to upend several approval pathways, including the current over-the-counter (OTC) pathway with one that emphasizes more OTC medicines available to patients with chronic conditions, reports Bloomberg . FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock said that FDA is looking to hold a public hearing in March to discuss the possibility of accelerating how ...
  • New Bipartisan Bill to Expand Accelerated Approval Pathway

    [Updated 6 March to Include Link to FAST Act.] An upcoming piece of legislation advanced by Reps. Cliff Stearns (R-FL) and Edolphus Towns (D-NY) would expand the US Food and Drug Administration's (FDA) use of the accelerated approval pathway , reports BioCentury . The Faster Access to Specialized Treatments (FAST) Act is reportedly similar to Sen. Kay Hagan's (R-NC) bill, the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act ,...
  • Hamburg: Smart Regulation Supports Public Health and Innovation, FDA Creating Business Liaison

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg delivered a speech at the Commonwealth Club of San Francisco on 6 February in which she discussed FDA's dual role in protecting health and getting innovative products to market. "As FDA commissioner, I have been surprised by how many people ask whether I favor safety or innovation," said Hamburg. "I favor both." "Protecting the public health-while encouraging, not discouraging innovation must be the ...