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  • Regulatory NewsRegulatory News

    Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation

    Eleven Senate democrats sent a letter to President Donald Trump on Tuesday explaining how his proposed cuts in the FY 2018 budget for the Department of Health and Human Services (HHS) will make implementation of the bipartisan 21st Century Cures Act much more difficult. "We urge you to listen to both sides of the aisle and drop any attempts to implement the damaging proposed cuts at HHS laid out in your budget," they wrote. Trump’s budget blueprint for 2018 ...
  • Regulatory NewsRegulatory News

    Release of New FDA Guidance Declines Sharply Following Trump’s Inauguration

    For an agency that has announced its intention to release more than 100 draft guidance documents in 2017, the US Food and Drug Administration (FDA) is off to a slow start following President Donald Trump’s inauguration. In the nearly three months since 20 January, FDA has only released two draft guidance documents and four final guidances. And all six of those documents were either slight tweaks to previously issued guidance, updates to expiration dates of older guidan...
  • Regulatory NewsRegulatory News

    Hiring Freeze at FDA: Upton and DeGette Say it Puts Priorities at Risk

    Hampering the US Food and Drug Administration’s (FDA) ability to hire puts bipartisan priorities at risk, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) wrote in a letter sent Tuesday to the acting director of the Office of Management and Budget (OMB). The letter comes as President Donald Trump in late January ordered a freeze on all government hiring, which has some exemptions for public health, though it’s unknown how the freeze impacts FDA or user fee funding to h...
  • Regulatory NewsRegulatory News

    ‘Two Out, One In’: Trump Signs Executive Order to Repeal Regulations

    President Donald Trump on Monday signed an executive order (EO) that would require all government agencies to eliminate two regulations for every new regulation instituted. The order , which White House officials characterized as a “one in, two out” plan to benefit small businesses, will likely impact the US Food and Drug Administration (FDA) as it applies to every agency but those related to military or national security-related branches of the federal government or ot...
  • Regulatory NewsRegulatory News

    FDA Stance on Naming Biosimilars Reportedly Finished, Awaiting Government Approval

    Two of the Senate's highest-ranking legislators on healthcare issues are calling on the Department of Health and Human Services to finish its review of a guidance document on the naming of biosimilar products drafted by the US Food and Drug Administration (FDA). Background In the US, the Patient Protection and Affordable Care Act (PPACA) of 2010 first created the pathway by which biosimilars—sometimes referred to as follow-on biologics or similar biological medicines—...
  • Regulatory NewsRegulatory News

    Hamburg, FDA Get a New Boss in New HHS Chief Sylvia Burwell

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg—and the agency she runs—will soon have a new boss. On Thursday, 5 June 2014 the full US Senate voted 78-17 to confirm Sylvia Matthews Burwell, former director of the Office of Management and Budget (OMB), to the position of secretary of the Department of Health and Human Services (DHHS). Burwell, once sworn in next week, will replace outgoing Secretary Kathleen Sebelius. While much of Burwell's fo...
  • What's Holding up FDA's Electronic Drug Labeling Rule?

    Legislators with the two committees that oversee the US Food and Drug Administration (FDA) want to know: What's holding up the agency's electronic labeling rule for pharmaceuticals? Background Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce uniformity were first passed. Those measures were substantially updated in 2006 under FDA's Requirements on Content and Format of Labeling for Human Prescript...
  • Legislators to OMB: Sequestration of FDA User Fees Wrong, Should be Reversed

    Legislators in the House of Representatives seem to have a consistent message for the White House's Office of Management and Budget (OMB), the office which effectively sets and enforces policy within the executive branch: Stop holding the US Food and Drug Administration's (FDA) user fees hostage. Background FDA's funding comes from a variety of different streams. While it receives a substantial amount of funding from the congressional appropriations process, it also rec...
  • Was OMB's Lengthy Review of the UDI Rule Worth the Wait?

    It's not yet clear how the US Food and Drug Administration's (FDA) unique device identification (UDI) rule will be remembered. After all, it has not yet been implemented. But if the rule is remembered for something, it may well be for the lengthy process it went through to eventually obtain approval, as well as the extensive and unexplained delays it went through along the way. Now, for the first time, the public is getting something of a glimpse at the behind-the-scen...
  • Federal Agency Says FDA's Benefits Far Outweigh its Costs

    A new draft report out by the White House's Office of Management and Budget (OMB), the government's regulator of regulators, shows that the cost-benefit ratios of the US Food and Drug Administration (FDA) vastly outweigh its costs to industry and the public at large, potentially giving the regulator clout with legislators who are increasingly looking to make budget cuts. The Report The draft report was published in response to the Regulatory Right-to-Know Act of 2001,...
  • Citing Congressional Gridlock, OMB Delays Release of 2014 Budget Proposal

    If you're waiting on the Obama Administration to release the contents of its budget for the 2014 fiscal year, the Office of Management and Budget (OMB), the executive office charged with formulating the President's budget, has a message for you: Wait a while longer. As in 2012, this year's budget is running late. In a letter sent to Rep. Paul Ryan, former vice presidential candidate and chairman of the House Committee on the Budget, OMB Acting Director Jeffery Zients n...
  • In Unusual Move, FDA Withdraws OMB Submission to Focus on Changes to Device Program

    If you're waiting for the US Food and Drug Administration's (FDA) guidance on planned changes to its medical device pre-submission meeting program, you may have to wait a bit longer. In a highly unusual Federal Register notice on 4 January 2013, FDA explained that it was withdrawing an earlier 11 December 2012 Federal Register notice in which it announced that it had submitted for review the guidance document The Pre-Submission Program and Meetings with FDA Staff ...