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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices

    Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way. Background On 24 April 2015, Sens. Richard Burr (R-NC), Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced the Advancing Breakthrough Devices for Patients Act ( ABDP Act ) . As written, the law is heavily based on the "breakthrough therapies" section ( Section 902 ) of th...
  • Regulatory NewsRegulatory News

    Legislation Overhauling Approval of Drugs, Devices Coming Next Week

    Congressional legislators are preparing to unveil the next iteration of the 21st Century Cures Act , a massive piece of draft legislation intended to overhaul the way in which the US Food and Drug Administration (FDA) regulates and incentivizes the development of new medical products. Background The legislation was first unveiled in January 2015 after months of discussions between legislators, regulators, industry, innovators, academics and patients. As extensively e...
  • Regulatory NewsRegulatory News

    Tougher FDA Approval Process for Opioids Sought by Congress

    New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). Background The bill, the FDA Accountability for Public Safety Act (FAPSA) , is a response to FDA's regulation of opioid painkillers, and specifically one known as Zohydro. The drug was approved in October 2013 as a pure hydrocodone product lacking any physical characteristi...
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    Does FDA Need New Authority to Regulate Complex Generic Drugs?

    New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority. Background The bill, the Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 , was introduced on 24 March 2015 by Rep. Michael Burgess (R-TX), a former physician and member of the House Energy a...
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    Bill Wants Drugs Approved in Europe to be Available More Quickly to US Patients

    New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe. Background The bill, the Speeding Access to Already Approved Pharmaceutical Act , is sponsored by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH), who introduced the same bill in June 2014 . As with the original, the bill targets something known in th...
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    Bill Would Give Some Reformulated Drugs Extra Protection from Generics

    New legislation introduced in the US House of Representatives would give some pharmaceutical products an extra two years of marketing exclusivity if their sponsors are able to demonstrate that the redesigned or reformulated drugs improve adherence, decrease abuse or otherwise make the drug safer to take. Background The bill, the Promoting Access for Treatments Ideal in Enhancing New Therapies (PATIENT) Act of 2015 , was introduced in the House on 13 March 2015 by Rep...
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    Leader Sought for FDA's Influential Office of Device Evaluation

    The US Food and Drug Administration (FDA) is seeking a permanent leader for its medical device-focused Office of Device Evaluation (ODE), the division responsible for reviewing nearly all medical devices marketed in the US. The office was most recently run by Christy Foreman, who stepped down in September 2014 to take a new role within FDA's new Center for Tobacco Products. Bill Maisel, deputy director for science and chief scientist at FDA's Center for Devices and R...
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    Senators Call for New Limits on 'Medically Important' Antibiotics

    A new bill introduced this week in the US Senate would restrict the use of "medically important" antibiotics in agriculture in the hopes of reducing the risk of bacteria developing resistance to those drugs. Background The bill, the Preventing Antibiotic Resistance Act (PARN) ( PDF ), was introduced on 2 March 2015 by Sens. Dianne Feinstein (D-CA) and Susan Collins (R-ME), with support from Sens. Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA). The legisl...
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    Legislators Want to Exempt Much of FDA's Funding from Future Budget Cuts

    New legislation introduced in Congress would exempt nearly half of the US Food and Drug Administration's (FDA) budget from austerity measures meant to help balance the federal budget. Background The bill, the FDA Safety Over Sequestration (FDA SOS) Act would specifically exempt FDA's user fees from the effects of future budget sequestration . The user fees, which come from the pharmaceutical and medical device industries, are meant to help fund FDA's regulatory...
  • Regulatory NewsRegulatory News

    DEA Scheduling Reform Bill Moves Forward in House

    The House of Representatives’ Energy and Commerce Committee has voted in favor of new legislation that would reform the way in which the US Drug Enforcement Administration (DEA) schedules new drug substances in the hopes of allowing patients to access new therapies more quickly. Background The bill in question, the Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
  • Regulatory NewsRegulatory News

    Will FDA Have to Change its Name? New Bill Takes the 'Food' out of FDA

    If a new bill introduced in Congress this week is ultimately passed, the US Food and Drug Administration (FDA) might soon need to change its 85-year-old name—and give up all of its authority to regulate food, including dietary supplements. The bill, known as the Safe Food Act of 2015 , is set to strip several regulatory bodies of their authority to regulate food products and transfer that authority to a new regulator, the Food Safety Administration (FSA), whose sole j...