• Regulatory NewsRegulatory News

    Senate Committee Advances Bill Redefining When a Drug is Officially Approved

    A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday. Background In order for a drug to be marketed, it must not only be approved by the US Food and Drug Administration (FDA), but the US Drug Enforcement Agency (DEA) must also schedule the drug to a particular class under the Controlled Substances Act (CSA). Under current law...
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    EMA Reflects on Advanced Therapy Classification

    The European Medicines Agency (EMA) has released a new reflection paper discussing how products are classified as advanced therapy medicinal products (ATMPs). Background In the EU, medicinal products derived from genes, cells or tissues are classified as ATMPs. Because these areas of biomedicine are still in early stages of development and are fundamentally different from other types of medicine, the European Commission (EC) regulates them differently. ATMPs are define...
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    Following Negative Comments by Reviewer, EU Committee OK's Gene Therapy

    Last month, German regulators postponed their review of UniQure's gene therapy Glybera after the European Medicines Agency (EMA) rapporteur assigned to the product claimed new data showed Glybera lacked efficacy and called for it to be reassessed . Now, EMA's Committee for Advanced Therapies (CAT) has completed its assessment, and is maintaining its positive opinion of Glybera, Reuters reports. Background Glybera is the first gene therapy approved for use in the E...
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    First EU-Authorized Gene Therapy Hits Snag, Benefit Assessment Delayed in Germany as EMA Reviews New Report

    Regulators at the German Federal Joint Commission (G-BA) have postponed their review of the gene therapy Glybera, Reuters reports . The decision was made after the European Medicines Agency (EMA) rapporteur assigned to Glybera found the product lacked efficacy and called for it to be reassessed. Glybera, which treats a rare condition called lipoprotein lipase deficiency (LPLD), made headlines both for being the first gene therapy approved in Europe and for its record-...
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    Are Biotechnology Products Safe for the Environment? FDA's New Policy Asks for Data

    While the US Food and Drug Administration (FDA) may be primarily concerned with what medicinal products do to the human body, a lesser-known secondary concern of regulators is what a product will do to the environment. Background Under 21 CFR 25.40 of the  Code of Federal Regulations , most pharmaceutical and biotechnology companies are required to submit an Environmental Assessment (EA) when submitting a new drug for approval. The assessments are meant to show how a...
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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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    House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved'

    The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products. 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...
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    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...
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    DEA Scheduling Process Targeted by Legislators Hoping to Speed up Drug Approvals

    The House of Representatives is in the advanced stages of considering legislation that could make it easier for some drug products to reach the market after being approved by the US Food and Drug Administration (FDA). Background In a notice posted to the House Energy and Commerce (E&C) Committee's website on 20 January 2015, Rep. Joe Pitts (R-PA) said he will hold a meeting on 27 January 2015 to consider several pieces of legislation, including the Improving Regulat...
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    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...
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    After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process

    For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA ) , the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA ...
  • Woodcock Lauds First Submission of 'Breakthrough' Product

    The US Food and Drug Administration (FDA) has already accepted its first product under its new "Breakthrough" therapies designation, and more are soon to be on the way, a high-ranking agency official said recently. In a 3 December 2012 announcement posted on FDA's Voice blog, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), sought to explain the law, calling it an exciting development for an agency that has long searched for effective...