• Director of OIRA to Step Down at End of August

    • 03 August 2012
    Cass Sunstein, the high-profile director of the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA), is set to resign from his position as the US' regulatory czar and return to teaching at Harvard University, reports Politico . Advanced remarks made available to Politico from President Barack Obama said Sunstein had been instrumental in, "Eliminating tens of millions of hours of paperwork burdens for our nation's citizens and busi...
  • UPDATED: Obama Signs FDA User Fee Bill Into Law

    US President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on 9 July 2012-12 days after the Senate approved the bill and 17 days after the House of Representatives passed the bill. The bill now carries the force of law, though its provisions largely do not come into effect until 1 October 2012. In a statement released by Press Secretary Jay Carney, the White House stated the President had "signed into law" FDASIA , a...
  • Report Highlights Negative Effects of Regulations on Regulatory Agencies

    Legislation and executive actions taken in recent years are increasingly looking to regulatory policy as a mechanism for promoting efficiency within the federal bureaucracy and competitiveness in the economy. The thinking is often based on the assumption that if regulatory agencies better understood the impact of the regulations being promulgated, they could better tailor them so as not to overly burden the industries they regulate. A new report by the public advocacy o...
  • 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 Throws Support Behind Senate User Fee Bill

    • 17 May 2012
    The Obama Administration has indicated it "strongly supports passage" of user fee legislation currently in the US Senate, saying it will "help speed safe and effective drugs, medical devices and biosimilar biological products to patients." The support of the White House-long expected but until now unannounced-comes as both chambers of the US Congress prepare to meet to vote on their respective versions of user fee legislation. The Senate is scheduled to vote on 17 May on...
  • New Bill Would Subject Regulations to Quadrennial Legislative Review

    A new bill proposed in the US House of Representatives would require the Office of Information and Regulatory Affairs (OIRA) to compile a report every four years recommending certain regulatory reforms to replace "outmoded, duplicative, ineffective or excessively burdensome" regulations. The bill, the Regulatory Reform Act of 2012 , would also require OIRA to compile a "list of recommendations to consolidate, modify, simplify or repeal" the regulations identified in i...
  • 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...
  • House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations

    • 08 May 2012
    An investigation by the US House Energy and Commerce Committee that began in January 2012 continues to escalate, with members of the committee directly targeting pharmaceutical companies in an attempt to discover what went on between the Obama administration and the pharmaceutical industry during negotiations on the Patient Protection and Affordable Care Act in 2010, reports Bloomberg . Members of the House Energy and Commerce Committee oversee the healthcare sector, ...
  • Obama Signs Order Promoting International Regulatory Cooperation

    US President Barack Obama signed a new Executive Order on 1 May that the White House hopes will promote international regulatory harmonization and reduce costly misalignments that stifle "economic growth, innovation, competitiveness and job creation." "In an increasingly global economy, international regulatory cooperation, consistent with domestic law and prerogatives and U.S. trade policy, can be an important means of promoting" a least-burdensome approach to regulatio...
  • 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...
  • US, Mexico and Canada Move to Harmonize Regulations

    US President Barack Obama, Canadian Prime Minister Stephen Harper and Mexican President Felipe Calderón announced at a press conference that the three contiguous countries are working together to harmonize regulatory approaches to facilitate cross-border trade. Speaking at the 2 April 2012 press conference, Obama announced the three nations were "launching a new effort to get rid of outdated regulations that stifle job creation."  "Here in the United States...