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  • Regulatory NewsRegulatory News

    As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition

    Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing complexity and role in critical clinical decision-making. And while the plan has received some pushback from legal groups , including the Washington Legal Foundation, it might soon have another, more prominent opponent: Members of Congress. Background LDTs are, as their name imp...
  • Regulatory NewsRegulatory News

    Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

    Senate legislators have released a new iteration of the Sunscreen Innovation Act , a bill which seeks to accelerate the approval of long-delayed new sunscreen ingredients in the US, which would go beyond sunscreen ingredients to overhaul part of the process used to approve over-the-counter (OTC) drugs. Background As explained in our article on the House version of the Sunscreen Innovation Act , the bill has long been focused on the Time and Extent (TEA) application ...
  • Regulatory NewsRegulatory News

    Legislators Call for FDA to Further Restrict Use of Phthalates in Medicines, Citing Risks

    In December 2012, the US Food and Drug Administration's (FDA) drug regulatory body, the Center for Drug Evaluation and Research (CDER), indicated that it wanted to limit the use of some phthalates as excipients in medicines. Now two legislators have a message for the agency: There's more that needs to be done. Background FDA's December 2012 guidance, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products , explained that the agency had foun...
  • Regulatory NewsRegulatory News

    Senators Say FDA Import Regulation Would Harm Vulnerable Consumers

    • 10 July 2014
    Four US senators are pressuring the US Food and Drug Administration (FDA) to walk back a rule proposed by the agency in May 2014 that would make it more difficult to import unapproved drugs into the US. Background The proposed rule, Administrative Destruction of Certain Drugs Refused Admission to the United States , is meant to tweak the agency's pharmaceutical import provisions under Section 801(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under the ...
  • Regulatory NewsRegulatory News

    FDA, Absent From Hearing, Makes the Case That it's Increasingly Innovative

    Yesterday, US legislators in the House Energy and Commerce Committee held a hearing to discuss how the federal environment—including the US Food and Drug Administration's (FDA) regulations—might be improved to bolster drug innovation. But while the pharmaceutical industry, device industry and patient groups found themselves well represented at the meeting, one prominent stakeholder found itself conspicuously excluded from the meeting: The US Food and Drug Administration. ...
  • House Committee Unveils Intent to Overhaul FDA Regulatory Framework

    A bipartisan group of legislators on the House Energy and Commerce Committee has launched a new initiative its members are calling the "21 st Century Cures Initiative," aimed at accelerating "the pace of cures and medical breakthroughs in the US." In a statement released on 30 April 2014, E&C committee members Fred Upton (R-MI) and Diana DeGette (D-CO) said they're looking to "broadly collaborate" with federal agencies, patients, scientists, academics and members of...
  • In Wake of Compassionate Use Debate, New Bill Promises Wider Access to Drugs and Devices

    New legislation introduced in the US House of Representatives this week would allow for the import, manufacture and sale of investigational drugs and devices meant to treat terminally ill patients. Overview and Background The bill, H.R. 4475, the Compassionate Freedom of Choice Act of 2014, comes in the midst of a long-running debate over whether current regulatory structures-and in particular FDA's Compassionate Use exemption process -is sufficient to treat termi...
  • Bill Would Create Incentives to Seek New Approvals for Old Biologics

    A new bill introduced in the US House of Representatives on 24 March 2014 would grant companies additional patent protections for repurposed biological products. Bill Basics The bill, the Independent Innovator and Repurposing Act (IIRA) , is cosponsored by Reps. Joaquin Castro (D-TX) and Randy Forbes (R-VA) and is intended to provide "appropriate intellectual property protections" for some products. Those products, the bill explains, are any biologicals regulated un...
  • Pressure Mounts on FDA to Reconsider Approval of New Painkiller

    A group of legislators in the House of Representatives have become the latest group to introduce legislation that would seek to specifically ban a new hydrocodone painkiller recently approved by the US Food and Drug Administration (FDA)-an action some critics say would undermine the regulator's authority and set a dangerous new precedent. Background FDA approved Zohydro ER (hydrocodone bitartrate) in October 2013. The approval decision was seen by many as surprising, as...
  • Pressure Mounts on DHHS to Overturn FDA Decision on Zohydro

    A senator has become the second legislator in two weeks to call on the secretary of the Department of Health and Human Services (DHHS) to exercise an authority-one used only once in the agency's history-to overturn a recent regulatory decision by the US Food and Drug Administration (FDA). Background: Zohydro That regulatory decision was with regard to Zohydro ER (hydrocodone bitartrate), a pure hydrocodone pill approved by FDA on 25 October 2013. The approval decision w...
  • 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...
  • Waxman, Author of Legislation Creating Generic Drug Industry, Orphan Drug Provisions, to Retire

    Representative Henry Waxman (D-CA), a Democratic legislator who has been a fixture in Congress and a major influence in legislation shaping the US Food and Drug Administration (FDA) since 1975, has announced that he will retire at the end of his current term. Waxman, 74, served on and once chaired the Energy and Commerce Committee, which has jurisdiction over FDA in the House of Representatives. The legislator may be best known for his role in creating the generic drug ...