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  • Regulatory NewsRegulatory News

    Senators Call for 15 Years of Marketing Exclusivity for Some New Drugs

    • 12 December 2014
    Two US senators have proposed new legislation that would grant an unprecedented 15 years of marketing exclusivity to certain types of pharmaceutical and biopharmaceutical products. Background The bill, known as the Dormant Therapies Act of 2014, is the second piece of legislation introduced in as many days by Sens. Orrin Hatch and Michael Bennet (D-CO). The duo introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act on 10 December 2014. R...
  • Regulatory NewsRegulatory News

    Bill Seeks Creation of New Pathway for Antibiotic Drug Approvals

    New legislation would allow the US Food and Drug Administration (FDA) to approve some antibiotics through a special "limited use" regulatory pathway, all in the hope of bringing more antibiotics to market to help fight antibiotic-resistant bacteria. A Limited Population Pathway The bill, the Promise for Antibiotics and Therapeutics for Health (PATH) Act , was introduced on 10 December 2014 by Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT). At its core, the legis...
  • Regulatory NewsRegulatory News

    Ebola Voucher Bill Clears Senate, on Course to Become Law

    The US Senate has passed legislation that would overhaul the Neglected Tropical Disease Priority Review Voucher  (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus. S.2917, the Adding Ebola to the FDA Priority Review Voucher Program Act , passed the US Senate by unanimous consent on 2 December 2013. "Today the Senate took a strong step to support that mission by pass...
  • Regulatory NewsRegulatory News

    Bill to Speed up Approvals for Sunscreen Ingredients, Other Drugs Awaits Obama's Signature

    US legislators in the House of Representatives have passed a Senate bill which would overhaul the manner in which the US Food and Drug Administration (FDA) approves sunscreen ingredients and other products through a rarely used regulatory pathway known as the Time-and-Extent process (TEA), all but assuring the bill will be passed into law. Background The bill, known as the Sunscreen Innovation Act (SIA) , follows extensive complaints by several companies that their sun...
  • Regulatory NewsRegulatory News

    US Senate Unveils Major Changes to FDA Program in Hopes of Fighting Ebola

    Legislators in the US Senate have unveiled a new piece of legislation meant to incentivize companies to go after the Ebola virus by making critical and long-sought changes to a US Food and Drug Administration (FDA) regulatory program. Background As Focus explained in October 2014 , a recent outbreak of Ebola has led to a scramble for new drugs and vaccines to help treat and prevent the virus. At present, there are no recognized treatments for the disease. Some publi...
  • Regulatory NewsRegulatory News

    Senators Call for Expansion of FDA Program to Help Fight Ebola

    Bipartisan members of the US Senate's healthcare oversight committee plan to introduce legislation that would amend a little-used regulatory program in the hopes of spurring the development of treatments for the Ebola virus. Background The program, known as the neglected tropical disease priority review voucher program, was created in 2007 under the Food and Drug Administration Amendments Act (FDAAA) . The voucher program, first envisioned in a 2006 Health Affairs po...
  • 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

    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—...
  • Senators Press FDA to Explain Regulation of Generic Opioids

    A group of senators are pressing the US Food and Drug Administration (FDA) to provide a more predictable pathway to market for generic opioid painkillers in the hopes of ensuring that new versions of the drug will retain the abuse-deterrent qualities of the existing products. Background FDA's policies on generic opioid painkillers have always been a bit wonky on account of the agency needing to balance two competing factors: policy and law. On one hand, the agency want...
  • Senator Looks to Bypass FDA and Remove Zohydro With Legislation

    A US senator is calling for the US Food and Drug Administration's (FDA) to ban a recently approved pure hydrocodone painkiller known as Zohydro ER (hydrocodone bitartrate), not through a letter or request, but by legislation. Background FDA approved Zohydro ER in October 2013. The approval decision was seen by many as surprising, as it followed an FDA advisory committee meeting at which a majority of the committee members voted against approving the drug, citing its pot...
  • As US Senate Goes 'Nuclear,' Future FDA Commissioners Could Benefit

    Commissioners of the US Food and Drug Administration (FDA) tend to stay at the agency for a while. Current FDA Commissioner Margaret Hamburg, for example, has been with the agency since 2009. Predecessors Andrew von Eschenbach, Mark McClellan and David Kessler were there for two, three and six years, respectively. But unless the agency is disbanded or Hamburg is the lucky recipient of a new drug application for eternal life, she will eventually step down from her positio...
  • US Congress Takes Interest in Regulatory Process with Flurry of Laws not Seen Since Early 2000s

    Have pity on the regulatory professional. Even under normal circumstances, the job of a regulatory professional-both those in government and in industry-is notoriously difficult, with long hours and highly complex and regulated material to work through. But even as pipelines have dried up and the stakes of regulatory approval have increased, regulators are dealing with one other challenge that has mostly flown under the radar: a parade of new legislative requirements. ...