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  • Regulatory NewsRegulatory News

    FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing

    The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change. The hearing discussed a bill that would seek to undercut FDA’s oversight of a program, known as expanded access, whereby terminally ill patients and their doctors can request access to an investigational drug outside of a clinical trial. Right-to-Try laws have now passed in 37 states...
  • Regulatory NewsRegulatory News

    House Subcommittee Advances User Fee Reauthorizations

    Following its Senate counterparts, the Energy & Commerce health subcommittee on Thursday advanced a bill to reauthorize the user fee agreements over the next five years for drugs, generic drugs, medical devices and biosimilars. All four amendments were agreed to, including one to increase generic drug competition and provide 180-day exclusivity for first generics where there’s a limited market, one on protecting the supply chain, one on improving the process for me...
  • Regulatory NewsRegulatory News

    House Committee Asks FDA for More Info on Contaminated Heparin Investigations

    Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed. In 2007 and 2008, heparin sourced from Chinese manufacturers was linked to the deaths of nearly 150 Americans. Questions of contamination resurfaced last year when French regula...
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    New House E&C Chairman to Consider Value-Based Drug Price Negotiations

    The newly minted chairman of the influential House Energy & Commerce Committee is looking to tackle pharmaceutical price gouging with a new bill and comments on how there need to be more negotiations to bring down prices. In an interview with The Oregonian this week, Rep. Greg Walden (R-OR), who attended Tuesday’s meeting with President Donald Trump and pharmaceutical CEOs , said: “Right now they're prevented from having those negotiations by law. We would fix that...
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    FDA Defends Plans to Regulate LDTs at House Hearing

    The US Food and Drug Administration (FDA) is making it clear to Congress that it's up to the task of regulating lab developed tests (LDTs). Speaking at a House Energy & Commerce Committee hearing today, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH) defended the agency's plan saying, "Getting the right treatment to the right patient at the right time depends on having accurate, reliable and clinically validated tests." Unlike traditi...
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    Marketing Exclusivity Provisions for Rare Disease Drugs Back in 21st Century Cures Bill

    An updated draft of the House Energy and Commerce (E&C) Committee's 21st Century Cures Act has reintroduced a provision which would extend marketing exclusivity for some drugs repurposed to treat rare diseases or conditions by six months. Background The provision, popularly known as the Orphan Product Extensions Now Act , was originally introduced in the US House of Representatives in November 2014. Under the bill, existing pharmaceutical products would be grant...
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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

    How Should Diagnostic Tests be Regulated? Congress Wants to Know

    A new white paper published by the House Energy and Commerce Committee is calling for feedback on the US Food and Drug Administration's (FDA) proposal to regulate laboratory developed tests (LDTs) more similarly to how they regulate in vitro diagnostics. Background Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to th...
  • Legislators Say Acquisition of US Pork Supplier Would Imperil Safety, Availability of Heparin

    House legislators are bringing new and critical attention to a proposed purchase of Virginia-based Smithfield foods, the world's largest pork processor, by Chinese company Shuanghui International, citing a past healthcare product regulation scandal that left dozens dead and few questions answered. Background In 2007 and 2008, regulators were left scrambling as dozens US citizens died after consuming products contaminated with adulterated heparin, a substance derived fro...
  • US Legislators Target Number of Regulatory Programs in 2013 Workflow

    The US House of Representatives' Energy and Commerce Committee, the legislative body charged with overseeing the US Food and Drug Administration (FDA), has released its planned workflow for the year, including a number of programs likely to affect regulatory professionals. Core Regulatory Programs The committee is broadly involved with healthcare, and was instrumental in passing the 2012 FDA Safety and Innovation Act (FDASIA) , which reauthorized and created a number...
  • Legislators Press FDA to Release Agency Materials Related to Meningitis Outbreak

    Republican legislators with the House's Energy and Commerce Committee, the committee charged with overseeing the US Food and Drug Administration (FDA), now say the agency has until 30 November to acquiesce to their demands for access to internal documents related to a recent outbreak of fungal meningitis. The Energy and Commerce Committee's subcommittee on health has been investigating an outbreak of fungal meningitis, now understood to have been caused by contaminated...
  • 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, ...