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    US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

    A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends. Background The report , authored by the President's Council of Advisors on Science and Technology (PCAST) and released on 18 September 2014, comes just as two troubling trends are intersecting. The first: Antibiotic resistance, which government officials blame for ...
  • PhRMA to FDA: Antibiotic Guidance Focuses too Much on Superiority

    The US pharmaceutical industry says a recent guidance issued by the US Food and Drug Administration (FDA) and intended to spur the development of new antibacterial therapies relies too heavily on superiority studies, potentially undermining legitimate needs and uses for drugs in light of advancing antimicrobial resistance to existing therapies. Background The draft guidance,  Antibacterial Therapies for Patients with Unmet Medical Need for the Treatment of Serious ...
  • FDA Doubles Down on Voluntary Approach to Limiting Use of Antibiotics in Food-Producing Animals

    The US Food and Drug Administration (FDA), bowing to decades of pressure, has agreed to "significant steps" it says will limit the prescribing of antibiotics to food-producing animals in an attempt to limit the spread of antibiotic-resistant bacteria. Background FDA's antibiotic use policy first began to take shape in the 1970s, and in recent years has been subject to intense scrutiny from outside advocates , former FDA officials , government investigators , and ev...
  • Extensive New Guidance Explains FDA's Recommendations for Streamlined Antibiotic Development

    A new draft guidance document released by the US Food and Drug Administration (FDA) provides extensive recommendations regarding the streamlined development of antibacterial products for patients with untreatable, serious infections. Background The draft guidance, released 1 July 2013, comes just as FDA is giving renewed attention to antibacterial products under the new Generating Antibacterial Incentives Now (GAIN) Act, a piece of legislation that was bundled into th...
  • FDA Looks to Spur Antibiotic Drug Development by Adding 18 Pathogens to Incentives List

    For several months, the US Food and Drug Administration (FDA) has been seeking public input on a proposed rule that would establish a list of "qualifying pathogens" under a provision of the FDA Safety and Innovation Act (FDASIA) that is intended to help spur the development of new antibiotics. Now, after an extensive input process, FDA is out with a proposed rule establishing that list. Background The provision is more commonly known as the Generating Antibiotics Inc...
  • EMA Looks to Cut Down on Antibiotic Resistance through New Efficacy Guidelines

    The European Medicines Agency (EMA) has announced the release of a new draft guideline regarding the testing of veterinary antibiotics, with regulators saying the changes provide greater detail on their expectations for demonstrating efficacy relative to a targeted microorganism. The guideline is in part intended to cut down on rates of increasing antimicrobial resistance, EMA wrote in an accompanying statement, with the theory being that ineffective drugs only serve to ...
  • Pharmaceutical Industry to FDA: Build Flexibility into GAIN Act

    When legislators passed a sprawling piece of legislation known as the Food and Drug Administration Safety and Innovation Act (FDASIA) , they considered a huge range of problems facing both the US Food and Drug Administration (FDA) and drug innovation and development in general. Among the provisions was one intended to spur the development of antibiotics known as the Generating Antibiotics Incentives Now (GAIN) Act , previously a stand-alone piece of legislation intende...
  • Group Sues FDA, Seeking 'Confidential Information' About Antibiotic Prescribing Data

    • 06 December 2012
    A consumer advocacy group has filed a lawsuit against the US Food and Drug Administration (FDA) for withholding data regarding the use and sale of antibiotics used in food-producing animals, saying the denial of its Freedom of Information Act (FOIA) request for the information was "unlawful." The group, the Government Accountability Project (GAP), which bills itself as a whistleblower protection organization, said it objects to FDA withholding certain data reported to ...
  • Waxman Introduces New Bill to Require Data Collection, Monitoring by Antibiotics Industry

    • 18 October 2012
    Representative Henry Waxman (D-CA), the ranking member on the House Energy and Commerce Committee, is preparing to introduce legislation that would increase the amount of information required of manufacturers who produce antibiotics for use in animals. The legislation would require the US Food and Drug Administration (FDA), which recently released an advanced notice of public rulemaking on the topic of antibiotic monitoring and use, to "increase information on the am...
  • Report: FDA Considering New Approval Paradigm for Socially Beneficial Drugs

    • 12 October 2012
    The US Food and Drug Administration (FDA) is considering allowing sponsors of select therapies to conduct smaller, faster clinical trials in return for a more restrictive labeling convention that would initially limit its use to a narrower group of patients, FDA Commissioner Margaret Hamburg told a group of scientific advisors. The remarks, reported by Bloomberg , potentially mark a paradigm shift for FDA, which has historically granted marketing licenses for new pr...
  • FDA Releases Draft Guidance on Abdominal Infection Products

    The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to the development of new pharmaceutical therapies for the treatment of complicated intra-abdominal infections (cIAIs), clinically common infections encompassing a wide swath of types of bacteria and locations. These infections are frequently diagnosed as intra-abdominal abscesses, perforations of the stomach or intestine, peritonitis, appendicitis with perforations or peria...
  • FDA Launches New Task Force to Assess Regulatory Hurdles Facing Development of Antibiotics

    The US Food and Drug Administration (FDA) is preparing to launch a new FDA-only task force set on supporting the development of new antibacterial therapies, part of the provisions of the recently passed FDA Safety and Innovation Act (FDASIA) . The task force was prescribed as part of FDASIA's "Generating Antibiotic Incentives Now (GAIN)" title, intended to grant new incentives for developers of antibiotic therapies. Those incentives include additional years of marke...