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    FTC Calls no-AG Commitment a Pay-For-Delay Agreement

    The Federal Trade Commission (FTC) on Friday found that an agreement not to market an authorized generic—called a “no-AG commitment”—can be considered a form of reverse payment to delay the entry of generic competition. The original complaint filed by the FTC in 2016 concerned the company Endo Pharmaceuticals, which sought to block the market entry of generic versions of two of its products: an opioid known as Opana ER and a lidocaine patch called Lidoderm, which togeth...
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    FDA Targets Homeopathic Medicines With Four Warning Letters

    Due to significant violations of current good manufacturing practice (CGMP) regulations, the US Food and Drug Administration (FDA) on Monday sent warning letters to four manufacturers of homeopathic medicines in Florida, North Carolina, Oregon and India. FDA highlighted how one company—Ashville, NC-based King Bio—"continues to concern us because of the low quality of their operation and the threat their products pose to consumers,” FDA Commissioner Scott Gottlieb said. ...
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    FDA Finalizes Rule on Biologic Inspections a Year After Pulling the Rule

    As part of President Donald Trump’s “two out, one in” executive order on new regulations, the US Food and Drug Administration (FDA) on Monday finalized a rule to amend biologics regulations related to time of inspection requirements and to remove certain inspector requirements. The finalization of the rule comes a little less than a year after FDA withdrew the same rule due to “significant adverse comment.” As the agency said when it previously proposed the rule, t...
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    DeGette Looks to Codify FDA Stance on Exclusivity for Deemed Biologics

    As part of a push to increase insulin competition and bring down the price of insulin, Rep. Diana DeGette (D-CO) and Tom Reed (R-NY) introduced a bill on Monday that aims to make certain US Food and Drug Administration (FDA) guidance into law. The guidance in question explains how FDA plans to transfer drugs previously approved under new drug applications (NDAs), including insulins, to be biologic license applications (BLAs) next March as part of the Biologics Price Co...
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    Fresenius to Pay $231M to Resolve Foreign Bribery Charges

    Germany-based Fresenius Medical Care on Friday agreed to pay about $231 million to resolve investigations by the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) because of Fresenius’s participation in various bribery schemes to win business in 13 countries. Between 2007 and 2016, Fresenius, which describes itself as the world’s leading provider of products and services for people with chronic kidney failure, admitted to paying bribes to publ...
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    EMA’s CHMP Recommends Gene Therapy With Record Review Time

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended a conditional marketing authorization for Bluebird Bio’s gene therapy Zynteglo (Autologous CD34+ cells encoding βA-T87Q-globin gene). Zyntelgo addresses the underlying genetic cause of transfusion-dependent beta-thalassemia, a rare inherited blood condition that causes severe anemia. Zynteglo is intended for patients 12 years and older who need regular blood...
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    Looking Back and Ahead, Gottlieb Discusses FDA

    Outgoing US Food and Drug Administration (FDA) Commissioner Scott Gottlieb continued his farewell tour of interviews on Friday with a detailed discussion with former FDA Commissioner Mark McClellan at the Pew Charitable Trusts. The wide-ranging conversation, thanks to the Alliance for a Stronger FDA, dovetailed from jokes (Gottlieb said on his resignation at one point: “Is it too late to change my mind?”) to more serious topics like opioids, the regulation of cell and g...
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    BIO Targets Compulsory Licensing, Regulatory Reforms Across Various Countries

    Following the release of PhRMA’s Special 301 Report urging the Office of the US Trade Representative to better protect American pharma companies’ intellectual property in foreign countries, BIO has released its own report this week, with an eye toward compulsory licensing and regulatory data protection. Similar to PhRMA, BIO singles out Malaysia as a “Priority Foreign Country” following the issuance of a compulsory license in 2017 to make generic versions of Gilead’s he...
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    MHRA Offers More No-Deal Brexit Guidance on Conditional Marketing Authorizations

    The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday published additional guidance in case the UK exits the EU without a deal, this time on conditional marketing authorization (CMA) applications, marketing authorizations in exceptional circumstances, and scientific advice. As for the CMA scheme, MHRA says it will have the same eligibility criteria as the EU scheme and that like in the EU, it is meant for treatments for serious and life-threatening ...
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    Gottlieb Seeks New Comparative Approval Standard for Opioids

    With just a week left before he departs from the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb on Thursday told the Senate Appropriations Committee that his agency is interested in Congress creating a new standard for opioid approvals whereby those seeking approval would be compared to opioids already on the market. “For this to work, the FDA believes that there should be a premarket demonstration that a new opioid is superior to an already-approved...
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    FDA Takes First Steps to Modify TIRF REMS Program

    The Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines is being strengthened by the US Food and Drug Administration (FDA) to better ensure the appropriate patients are receiving these opioids, the agency announced Wednesday. Following an advisory committee meeting on the REMS last August, as well a recently published study in JAMA that found that “thousands of patients receiving TIRFs were opioid-nontolerant...
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    House E&C Subcommittee Advances 5 Bills Related to Generic Competition

    The House Energy & Commerce Committee’s Health Subcommittee on Wednesday advanced five bills seeking to help increase generic drug competition. All five will now be considered by the full committee. Much of the discussion and disagreement across the aisle centered on two bills: one, known as HR 1499 , the Protecting Consumer Access to Generic Drugs Act of 2019 , which seeks to prevent brand name drug and biologic manufacturers from compensating generic and biosimilar ...