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  • Regulatory NewsRegulatory News

    New California Laws Set Sights on Pay-for-Delay Agreements, HIV Prevention

    California Gov. Gavin Newsom (D) on Monday signed into law one bill that aims to crack down on pay-for-delay deals that can block the launch of generic drug competition and one bill that will allow pharmacists, under specific circumstances, to distribute limited supplies of HIV drugs without prescriptions. California’s new pay-for-delay law is the first in the nation directed at the deals between pharmaceutical companies in which one company pays a competitor to delay r...
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    House E&C Committee Addresses 7 Bills to Improve Generic Competition

    The House Committee on Energy & Commerce’s health subcommittee on Wednesday held a hearing to discuss seven bills that help generic drug companies gain access to samples for testing necessary to win generic approval, tweak parts of the 180-day exclusivity that first generic filers can win and make updates to the Orange Book of generic drug patents and the Purple Book for biosimilars. All seven bills are part of Congress’ attempt to bring more generic drug competition to...
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    European Commission Focuses New Report on Pharma Competition Enforcement

    The European Commission (EC) on Monday released a report on pharmaceutical competition enforcement activities by the Commission and EU member states' national competition authorities from 2009 to 2017.   The 46-page report was put together in response to concerns voiced by the European Council and Parliament in 2016 and 2017 regarding anticompetitive practices within the pharmaceutical sector, such as tactics to delay generic competition, pay-for-delay arrangements...
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    Gottlieb: 'End the Shenanigans' on Delaying Generic Drug Competition

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday called to "end the shenanigans" that often delay or restrict generic drug competition. The comment followed Gottlieb's discussion of the ways in which brand-name drug companies can use Risk Evaluation and Mitigation Strategies (REMS) or other tactics to prevent generic companies from purchasing drug product to run bioequivalence or bioavailability studies necessary for approval. Federal...
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    Pay-for-Delay Deals: FTC Notes Continued Decline Since SCOTUS Ruling

    The total number of deals in which brand name drugmakers pay to delay the entry of generic competitors continues to decline, and only 5 of the 170 final settlements in FY 2015 included compensation to the generic and a restriction on generic entry, the Federal Trade Commission (FTC) said in a report released Wednesday. FY 2015 is the second complete year of filings since the Supreme Court decided FTC v. Actavis, Inc. in June 2013, when it found that a branded drug ...
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    ‘FAST’ Generics Act Seeks to Thwart Abuse of FDA Safety Programs

    A bipartisan House bill introduced on Friday seeks to stop pharmaceutical companies from blocking generic competitors by abusing US Food and Drug Administration (FDA) safety programs. The “Fair Access for Safe and Timely Generics Act of 2017,” or “FAST Generics Act of 2017,” introduced by Reps. David McKinley (R-WV) and Peter Welch (D-VT) would amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible generic and biosimilar developers have competitive acce...
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    FTC Continues Crackdown on Pay-for-Delay Agreements

    The Federal Trade Commission (FTC) on Monday announced several steps taken against Allergan, its subsidiary Watson Laboratories and Endo Pharmaceuticals to fight pay-for-delay settlements between brand-name and generic drug manufacturers that keep generics from entering the US market. According to a complaint filed in the US District Court of Northern California against Allergan, Watson and Endo, FTC is challenging an anticompetitive reverse-payment agreement between En...
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    Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic

    Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market. Background As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced in August that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-n...
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    Teva’s Cephalon Reaches $125m Settlement With 48 States Due to Generic Delays

    Teva Pharmaceutical’s Cephalon and state attorneys general on Thursday announced a $125 million, 48-state settlement after an investigation into the company’s delaying of generic versions of its top product. Cephalon, which denies any wrongdoing and was acquired by Teva in 2011, was accused of delaying generic versions of its sleep disorder drug Provigil (modafinil). The settlement with every state and Washington, DC (but not including California and Louisiana) follows...
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    FTC Sues Drugmakers for Not Marketing Authorized Generics

    The Federal Trade Commission (FTC) for the first time ever filed a complaint in federal district court this week alleging that an agreement not to market an authorized generic – often called a “no-AG commitment” – is a form of reverse payment and violates antitrust laws. The complaint alleges that Endo Pharmaceuticals and several other drug companies violated antitrust laws by blocking access to generic versions of the pain drug Opana ER (oxymorphone) and the local anest...
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    FTC: Pay-For-Delay Deals Decrease Significantly After Supreme Court Ruling

    The number of pay-for-delay settlements decreased significantly in 2014 after a Supreme Court decision in 2013 found that a branded drug manufacturer’s reverse payment to a generic competitor to settle patent litigation can violate antitrust laws. The findings from the Federal Trade Commission (FTC) note although the number of settlements slightly increased last year – 160 in FY 2014 vs. 140 in FY 2013, 145 in FY 2012 and 156 in FY 2011 -- the number of potential pay-for...
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    Senators Reintroduce Bill to Make Pay-For-Delay Deals Illegal

    US Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) on Wednesday reintroduced a bill that would prevent branded and generic drug companies from forging deals that delay the launch of generics. The reintroduced  Preserve Access to Affordable Generics Act aims to increase consumers’ access to generic drugs by making the so-called pay-for-delay deals illegal. On average, pay-for-delay deals restrict access to generics by nearly 17 months, according to the senators. ...