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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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    HHS Establishes Organ Donation Policy for Patients With HIV

    The US Department of Health and Human Services (HHS) has unveiled new regulations to establish a parallel system of organ donation intended to serve patients with the human immunodeficiency virus (HIV). Background The regulations come almost a year and a half after US President Barack Obama signed into law the HIV Organ Policy Equity (HOPE) Act of 2013 . The law, passed in November 2013, modified the National Organ Transplant Act (NOTA) of 1984 by permitting HIV-p...
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    FDA Exercising 'Extraordinary' Flexibility on Drugs for Rare Diseases, New Study Finds

    The US Food and Drug Administration (FDA) is a reasonable regulator. That's the conclusion of a new analysis looking at the measures taken by FDA to review and approve new drugs intended for use in rare diseases affecting small populations of patients. Background The root of this "reasonable" argument starts with a law intended to facilitate the development of new therapies for patients with rare diseases. Under the 1983 Orphan Drug Act , a rare disease is one which a...
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    Regulatory Explainer: The (Updated) 21st Century Cures Act

    The US House Energy and Commerce (E&C) Committee has released an updated draft of a piece of legislation which proposes dramatically overhauling the way in which the US Food and Drug Administration (FDA) regulates many healthcare products. The bill, the 21st Century Cures Act , has been under development since at least April 2014, when the E&C Committee kicked off its "21st Century Cures Initiative." The initiative is intended to speed up the pace at which FDA approve...
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    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...
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    HHS Says it Will Shield Maker of Ebola Therapy ZMapp from Legal Liability

    The US Department of Health and Human Services (DHHS) says it will shield the manufacturer of the investigational Ebola virus treatment ZMapp from legal liability under a federal law intended to incentivize the development of new medical products for medical emergencies. Background Under emergency scenarios—the outbreak of a new disease or a disaster—federal legislation permits the US Food and Drug Administration (FDA) to authorize the use of new medications and medical...
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    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...
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    FDA Kicks off Generic Drug User Fee Reauthorization Process

    Regulators and generic pharmaceutical companies, start your engines. The race to the next reauthorization of the Generic Drug User Fee Act (GDUFA) has begun. In a Federal Register notice on 21 April 2015, the US Food and Drug Administration (FDA) announced that it will begin accepting comments regarding the first-ever reauthorization of GDUFA—a user fee arrangement which funds much of FDA's generic pharmaceutical regulatory activities. Background GDUFA was first pa...
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    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 Would Make Permanent FDA's Rare Pediatric Voucher Program

    New legislation introduced this week would reauthorize the US Food and Drug Administration's (FDA) rare pediatric disease priority review voucher program, which is currently set to end after triggering a sunset clause in its authorizing statute. Background Priority review vouchers are incentives meant to catalyze the development of new therapies for historically under-served disease areas, such as rare pediatric diseases affecting fewer than 200,000 children in the US...
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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...