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  • Regulatory NewsRegulatory News

    Obama’s FY 2017 Budget Request: $5.1B for FDA, New Ways to Tackle High Drug Prices

    President Barack Obama unveiled his final budget request on Tuesday, and though Republicans have said it’s dead on arrival, the US Food and Drug Administration (FDA) would receive an 8 percent increase in funds to help further address drug compounders, device submissions and supply chain security. New ways to combat high prescription drug prices were also included in the request. The overall request from Obama and FDA includes a net increase of $14.6 million in budget au...
  • Regulatory NewsRegulatory News

    Senators Urge Obama to Take Action on Drug Prices

    Policy solutions to bring down the rising tide of prescription drug prices should be included in next year’s budget, eight senators said in a letter sent to President Barack Obama on Tuesday. Examples of ways Obama could help to lower drug costs include requiring drugmakers to provide rebates on prescriptions for Medicare Part D low-income subsidy enrollees “in the same way that it does already for Medicaid recipients,” the senators said, noting that about $120 billion c...
  • Regulatory NewsRegulatory News

    US Special Counsel Finds FDA Whistleblower's Device Approval Concerns Unsubstantiated

    The claims of an anonymous whistleblower within the US Food and Drug Administration (FDA) that employees of the Center for Devices and Radiological Health (CDRH) created public health dangers by approving the use of a digital mammography device and several colonography devices were found to be unsubstantiated, according to a letter sent by the US Office of Special Counsel (OSC) to President Barack Obama. Background Six staff scientists, former employees of CDRH's Office...
  • Regulatory NewsRegulatory News

    Obama: Let's Take Food Regulation out of FDA

    The US Food and Drug Administration (FDA) could stand to lose all of its authority to regulate food products, potentially including dietary supplements, under a new proposal unveiled by President Barack Obama this week. Background The proposal, contained within Obama's budget proposal for fiscal year 2016, would consolidate all regulatory authority for food under a "single new agency within The Department of Health and Human Services," according to the budget. "This ne...
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    Legislators to Obama: Help us in Effort to Reform FDA Regulation

    For months, legislators on the House Energy and Commerce (E&C) Committee have been working with a large group of stakeholders in the hopes of developing a series of reforms to the way the US Food and Drug Administration (FDA) approves new drugs and medical devices. Now the committee has reached out in the hopes of recruiting one especially important stakeholder to its cause: President Barack Obama. Background The legislative effort, known at the 21st Century Cures Init...
  • Regulatory NewsRegulatory News

    Obama Signs Special Ebola Incentive Program Into Law

    President Barack Obama has signed a new bill into law allowing any pharmaceutical or biotechnology company that successfully develops a product to treat the Ebola virus to obtain a special voucher potentially worth millions—and even billions—of dollars. The law, Adding Ebola to the FDA Priority Review Voucher Program Act , was signed into law by Obama on 16 December 2013. The law focuses on FDA's neglected tropical disease priority review voucher (PRV) program, a pro...
  • Regulatory NewsRegulatory News

    Obama Approves Bill Reforming Regulation of Sunscreen Ingredients, Other Drugs

    US President Barack Obama has signed into law a new bill set to change the way in which some drugs, and in particular sunscreen ingredients long approved in other countries, are regulated by the US Food and Drug Administration (FDA). Background The bill, the Sunscreen Innovation Act (SIA), was signed into law by Obama on 26 November 2014 following its passage in the House of Representatives on 14 November 2014. The bill's passage follows extensive complaints by s...
  • Focus on OIRA, Regulator of Regulatory Agencies, as Obama Prepares for Second Term

    What's next for the White House's Office of Information and Regulatory Affairs (OIRA)? The agency, a sub-agency of the Office of Management and Budget (OMB), is sometimes referred to as the regulator of regulators; the agency charged with reviewing regulations promulgated by other agencies to ensure they meet federal guidelines and are generally cost-effective and minimally burdensome. That mission has made it the bane of more than a few regulatory agencies, including ...
  • Data Exclusivity for Biologics at Forefront of International Trade Agreement Negotiations

    • 08 October 2012
    • By
    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...
  • President Obama Signs into Law Three Bills Affecting FDA

    US President Barack Obama has signed into law three pieces of legislation that affect-directly or indirectly-the activities of the US Food and Drug Administration. User Fees Front and Center The first, and perhaps the most important, bill  was House Joint Resolution 117, the Continuing Appropriations Resolution of 2013 . The bill would maintain funding for US government agencies at fiscal year 2012 levels. While not specifically aimed at FDA, without the legis...
  • More than $110 Million in FDA User Fees to be Seized Under Sequestration

    The US Food and Drug Administration (FDA) stands to lose more than $300 million in funding and industry-paid user fees under a budget sequestration process scheduled to come into effect in January 2013, according to a new report released by the Office of Management and Budget. The report, " OMB Report Pursuant to the Sequestration Transparency Act (STA) of 2012 ," came in response to legislators' demands that the executive branch release more information regarding th...
  • FDA Could Soon Have Better Information to Plan for Massive Budget Cuts

    Officials at the US Food and Drug Administration (FDA) may soon have a better sense of the impact of an upcoming budget sequestration measure thanks to a new piece of legislation signed into law 7 August by President Barack Obama. The bill, the Sequestration Transparency Act of 2012 , comes as partisan wrangling over the impact of the Budget Control Act of 2011 comes to a head. The act was the culmination of a tense budget standoff between congressional Demo...