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FDA Week - 06/23/2017

  • FDA Plans Generic Meeting, Seeks Input On REMS, Pay-For-Delay

    FDA Commissioner Scott Gottlieb is acting on his promise to congressional appropriators that the agency will hold a public meeting examining potentially anti-competitive actions meant to keep generics off the market. In preparation for that meeting, set to be held July 18, FDA is asking for public comment on how the agency can tackle abuses of Risk Evaluation and Mitigation Strategies, patent evergreening and pay-for-delay agreements, among others. Gottlieb says public input will help shape the agency's Drug Competition Action Plan aimed at bringing down drug prices through expanding access to generics.

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  • Gottlieb: FDA Drafting Medical Innovation Plan To Lower Health Care Costs

    FDA will create a "Medical Innovation Development Plan" aimed at lowering health care costs by facilitating development of drugs to treat costly rare diseases through improved adaptive trial designs and statistical tools, agency chief Scott Gottlieb announced Tuesday (June 20). The Biotechnology Innovation Organization said Gottlieb's commitment to streamline clinical trials would improve outcomes and lower costs, but Public Citizen said the plan would lower the evidentiary standard for drug approvals and pose new risks to consumers.

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  • OTC Monograph User Fees Would Cut Review Time, Allow For IT Platform

    A draft document obtained by Inside Health Policy sets out expected performance goals for an over-the-counter monograph user fee program (OMUFA) under which FDA would see improved review timelines and more efficient review capacity by year four of the program. Assuming Congress enacts OMUFA and it goes into effect by Oct. 1, 2017, FDA and industry could expect to see an increase in OTC monograph review staff and reductions in review time, published draft and final guidance detailing processes, and the establishment of a public-facing information technology dashboard.

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  • FDA Won't Say Whether It Will Weigh In On Biosimilar Pathway Ruling

    FDA will not say whether it will answer a call from Supreme Court Justice Stephen Breyer for the agency to craft its own interpretation of the biosimilar pathway. Two FDA sources, including the agency's head of biosimilars, declined to answer Inside Health Policy's question whether the agency will engage in rulemaking to further lay out the pathway. The agency previously was petitioned to weigh in and denied the request because of pending litigation -- but now that the legal issues are presumably settled, FDA declines to say whether it will now do so on the contentious issue.

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  • Sandoz Appears Concerned Over Interplay of State Laws And Patent Dance

    Despite prevailing in the highly watched Amgen v. Sandoz Supreme Court decision, it appears Sandoz is still concerned over lack of clarity regarding how state laws can be used to compel the patent dance -- an issue that was raised by Associate Justice Sonia Sotomayor during oral arguments. The biosimilar sponsor had spoken out against
    the suggestion that the high court should remand the state law issue, which the court eventually did. While officials from both sides offered brief remarks on the case during the DIA annual conference, Amgen declined to opine on the potential impact of the case on the industry.

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  • NASHP Launches Center For State Rx Drug Pricing

    The National Academy for State Health Policy launched the Center for State Rx Drug Pricing to provide actuarial, legal and financial support to states trying to control drug spending as they take the lead on curbing drug price increases.

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  • Retired Judge: Courts Will Force Patent Exchange Despite Amgen v. Sandoz

    Despite the Supreme Court's recent ruling that an injunction cannot be used to compel participation in the so-called biosimilar patent dance, one retired district court judge recently argued that this information will still be exchanged during discovery given that courts will develop local rules to compel information exchange, in an effort to ensure that declaratory-judgment actions can move forward. However, one innovator-side attorney indicated that industry feels relying on declaratory-judgment actions to gain access to information is inefficient and could lead to gamesmanship.

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  • Sen. Collins Considers Using Medicare Part D To Stop REMS Abuses

    Sen. Susan Collins (R-ME) is considering using Medicare Part D as leverage to stop brand drug makers from gaming FDA drug-safety policy to thwart generic competition.

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  • FDA Seeks Comment On Draft Guidance On Securing Clinical Trial Data

    FDA has issued draft guidance that updates requirements for the handling of electronic records and data used in reviewing drugs and medical devices as part of clinical trials.

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  • BIO: Patient Affairs Office Should Not 'Supplant' PDUFA, Cures Provisions

    CHICAGO -- In the wake of FDA's announcement that it plans to create an Office of Patient Affairs (OPA), the Biotechnology Innovation Organization cautions against letting the office overtake measures in the 21st Century Cures Act and pending drug user fee package calling for FDA to assign liaisons between the agency and drug sponsors to help facilitate communication during the drug development process, as well as a provision pushing development and use of patient-focused methods to inform drug development and regulatory decisions.

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  • GAO: FDA & FTC Should Clarify Internet Oversight Of Dietary Supplements

    Congress' investigative arm is pressing FDA and the Federal Trade Commission to delineate their overlapping roles in overseeing internet marketing of dietary supplements so that consumers know where to report supplement problems, which in turn could boost enforcement action against bad actors. The two agencies told investigators they will work on such guidance.

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  • FDA Draft Guide Tackles User Fee Goal To Speed Generic Drug Reviews

    FDA isn't waiting for the generic drug user fee reauthorization measure to move through Congress to move forward with one of the package's commitments: A new draft guidance issued this week sets up a new pre-submission process for certain generic drug applications, which FDA chief Scott Gottlieb says could cut two months off review times and increase access to affordable drugs.

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  • Global Regulators: No Consensus On Use Of RWE To Support Approvals

    CHICAGO -- Despite a recently finalized mutual recognition agreement between the European Medicines Agency and FDA, much more work needs to be done to come to consensus on the use of real-world data to support drug approvals, global regulators said Wednesday (June 21). FDA, which has largely embraced real-world data, was noticeably more enthusiastic about the potential of RWE, compared to its European counterpart, but despite the apparent difference of opinion, FDA emphasized that consensus among countries is an important goal.

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