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  • Senator Calls--Again--for White House to Release Sunshine Act Rules

    A prominent senator is once again calling upon federal officials to pass a long-delayed rule regarding the transparency of payments made by companies to healthcare providers, saying the delays are "unacceptable." Sen. Charles Grassley (R-IA), is the ranking Republican member of the Senate Committee on the Judiciary, and along with former Sen. Herb Kohl (D-WI) sponsored and wrote the Physician Payments Sunshine Act (Sunshine Act), which eventually became part of the 201...
  • Chinese Firm Used White Out to Change Regulatory Records, FDA Says

    Chinese over-the-counter (OTC) manufacturer Shanghai Huhui Daily Use Chemical Products Company ('Shanghai Huhui') has been blasted by US Food and Drug Administration (FDA) inspectors for allegedly interfering with an investigation of the facility by using white-out on regulatory documents, among other serious alleged violations. The alleged deficiencies are outlined in a 14 November 2012 warning letter to Shanghai Huhui, released to the public on 5 December 2012. In ...
  • Data Exclusivity for Biologics at Forefront of International Trade Agreement Negotiations

    • 08 October 2012
    A host of biopharmaceutical regulatory issues are said to be at the forefront of trade talks between the US and a group of 11 countries in the Asia-Pacific, potentially complicating both the agreement and the Obama administration's already complicated relationship with the pharmaceutical industry, reports Reuters . The agreement in question is known as the Transpacific Partnership (TPP)-a regional trade policy long under negotiation and periodically subject to trans...
  • New Report Calls for Overhaul of Regulatory Processes with Goal of Doubling Drug Approvals by 2027

    A new report released by the President's Council of Advisors on Science and Technology (PCAST) has called for the US Food and Drug Administration (FDA) to approximately double the number of pharmaceutical products it approves each year by the end of 2027. The report, Propelling Innovation in Drug Discovery, Development and Evaluation , comes on the heels of two reports released earlier in 2012 which called for, respectively, a more refined regulatory approach for n...
  • House Releases Previously-unreleased Email Exchanges Between White House, PhRMA

    • 31 May 2012
    A Republican-led investigation into then-secret negotiations between the Obama Administration and the Pharmaceutical Research and Manufacturers of America (PhRMA) has released its preliminary results, consisting of hundreds of pages of internal memoranda and emails between the White House and PhRMA. The investigation has been underway since at least January 2012 when Republican members of the House of Representatives expressed their anger at the Obama Administration appe...
  • White House Wants Agencies to Develop Mobile Technologies, Open APIs

    • 25 May 2012
    A recent memo from the White House to the heads of executive departments and agencies directs them to immediately begin implementation of a new "digital strategy" aimed at making governmental information more readily and easily accessible to citizens and stakeholders. The 23 May memo outlines the government's new information accessibility strategy, contained in an accompanying report entitled, " Digital Government: Building a 21 st Century Platform to Better Serve the A...
  • New Executive Order Directs Agencies to Identify and Reduce 'Regulatory Burdens'

    • 10 May 2012
    The White House has released a new executive order directing federal agencies to identify and reduce "regulatory burdens" in their respective organizations, noting the "challenging economic times" the US is traversing. President Barack Obama's executive order, "Identifying and Reducing Regulatory Burdens", builds upon an existing order by the president ordering agencies to periodically review existing significant regulations and find efficiencies within them. Obama's st...
  • FDA to Delay Implementation Date for Sunscreen Labeling and Testing Changes

    The US Food and Drug Administration (FDA) announced 10 May it will delay implementation of a final rule intended to establish labeling and effectiveness testing for over-the-counter (OTC) sunscreen products, marking the latest development in a long struggle over the regulation of sunscreen products. FDA's final rule establishes new requirements for sunscreen products containing specific active ingredients and marketed without approved applications, "amends labeling claim...
  • New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices

    The White House Office of Science and Technology (OST) released its National Bioeconomy Blueprint , which charts the course for the future development of bioscience research in the US and addresses numerous regulatory issues. The blueprint is described as a priority of the administration because of the "tremendous potential for growth and job creation." While basic research is an important aspect of the bioeconomy, said OST, regulatory issues are key drivers of ...
  • New Bioethics Chief Takes Helm at White House

    US President Barack Obama's newly-appointed bioethics chief started work Monday, 9 April, marking a key leadership transition for a board that has already investigated numerous controversial clinical research topics related to regulatory affairs. The panel, called The Presidential Commission for the Study of Bioethical Issues, is a 13-member advisory commission that was formed in 2009.  The commission itself will still be led by Commission Chair Amy Gutmann, P...
  • Report: Clashes Between White House, FDA Frequent

    A report in The New York Times indicates the US Food and Drug Administration (FDA) and the Obama Administration are frequently at odds-partially the result of poor communication and partially the result of poor political optics-which has caused significant amounts of tension between the two government bodies. The report notes numerous instances where the Administration and FDA have clashed, including the banning of Primatene asthma inhalers, Health and Human Services S...
  • Group: Industry Lobbying Tarnishing FDA Integrity

    The science advocacy group Union of Concerned Scientists (USC) is lambasting what it claims is excessive industry pressure on the US Food and Drug Administration (FDA), and claims the pharmaceutical, medical device and biotechnology sectors spent a combined $700 million between 2009 and 2011 to lobby legislative and executive officials. "Pharmaceuticals companies and related trade groups spent more than $487 million on lobbying over this three-year period, while biotechn...