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FDA Week - 10/13/2017

  • FDA Panel Urges Approval Of Gene-Therapy For Genetic Form Of Blindness

    An FDA expert panel unanimously voted Thursday (Oct. 12) to recommend approval of Spark Therapeutics' Luxturna (voretigene neparvovec) -- a gene therapy used to treat patients with a rare form of genetically-inherited blindness -- that some analysts say could cost nearly $1 million per patient. While the data presented did show a statistically significant improvement in the primary endpoint, FDA said it was unclear whether the endpoint -- improvement in navigating a maze -- correlated to improvements in functioning beyond those directly tested.

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  • FDA To ITC: Don't Take Up Amarin Omega-3 Complaint, Pom Doesn't Apply

    FDA's top lawyers argue that the U.S. International Trade Commission should not take up a recent unfair competition case filed by Amarin Pharma asking the commission to block importation and essentially freeze U.S. inventory of certain synthetic omega-3 products being sold as dietary supplements. The lawyers note that FDA hasn't determined whether the challenged products are drugs or dietary supplements, and argue ITC would usurp FDA's legal responsibility to decide the regulatory status of products and open the door for other challenges should it take up the case.

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  • AAM Weighs Options On California Drug Pricing Law

    Top pharmaceutical trade groups haven't yet said they will sue over California's newly signed drug pricing law, but the generics trade group tells Inside Health Policy it is weighing its options. One drug pricing expert who has advocated for similar legislation says the California law is less susceptible to the patent law and Takings Clause challenges faced by other states' drug-pricing laws, but multiple industry trade groups allege the California law raises trade secret concerns.

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  • Gottlieb: FDA To Set Up Patient Affairs Team To Steer Patient Engagement

    FDA Commissioner Scott Gottlieb announced Wednesday (Oct. 11) that the agency will establish a patient affairs team that will "be responsible for the coordination of certain agency-wide and multi-center projects related to patient engagement." The announcement came as the agency held the first meeting of its Patient Engagement Advisory Committee (PEAC), during which patients and patient advocates, industry and FDA discussed ways to increase and incentivize patient participation in clinical trials.

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  • Stakeholders Call For FDA Policy On Patient Engagement In Clinical Trials

    During the first meeting of FDA's Patient Engagement Advisory Committee (PEAC) on Wednesday (Oct. 11), patients and patient advocates, industry, and FDA discussed a need to craft regulatory policy around patient engagement in clinical trials and provided solutions for increasing and possibly incentivizing patient participation and retention in studies.

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  • FDA To Advise New NIH/Biopharmaceutical Partnership On Immunotherapy

    FDA will help serve in an advisory role for a new public-private partnership between the National Institutes of Health (NIH) and 11 major biopharmaceutical companies. The goal of the partnership, which is part of the Cancer Moonshot initiative, is to "identify, develop and validate robust biomarkers" to advance the development of immunotherapies to treat cancer, NIH announced Thursday (Oct. 12).

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  • FDA Issues Final Emerging Tech Program Guide, PhRMA Seeks Incentives

    FDA's final guidance on the use of emerging technology in pharmaceutical manufacturing remains largely unchanged from the 2015 draft guidance, despite the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Association for Accessible Medicines (AAM) calling for the agency to list suitable technologies and detail the criteria for being accepted into the program. While generally supportive of the final guidance, PhRMA tells Inside Health Policy it would like FDA to come up with incentives for industry to participate. And AAM notes the guidance does not delve into the differences between the generic and branded industries.

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  • FDA Awards Six Grants For Studies On Natural History Of Rare Diseases

    For the first time, FDA has awarded research grants intended to fund natural history studies of rare diseases, the agency announced Friday (Oct. 6). FDA Commissioner Scott Gottlieb has previously touted the benefits of natural history models saying they could make clinical trials more efficient by allowing "FDA to model some aspects of the behavior of the placebo arm in clinical trials."

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  • McCaskill Introduces Bill To Block Allergan-Esque Patent Schemes

    One key Democratic senator has introduced a bill that would strip tribes of their sovereign immunity under the inter partes review process, which if passed would effectively kill the idea of selling drug patents to tribes in an effort to shield those patents from the IPR process. The sponsor, Sen. Claire McCaskill (D-MO), made clear in a press release announcing the bill that it was in direct response to a controversial deal between Allergan and the Saint Regis Mohawk Tribe meant to shield Allergan's Restasis from pending IPR challenges.

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  • FDA Allows Importation Of Four IV Drugs After Hurricanes

    FDA has authorized importation of four drugs from Europe in response to shortages caused by Hurricane Maria. The agency stated Sept. 28 that hurricanes had left 40 high-priority drugs at risk of shortage, and as of Tuesday (Oct. 10) three of the products now being greenlighted for importation appear to be in shortage. However, one product now being imported does not appear to be on FDA's shortage list.

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  • Generic, Hospital, PBM, Insurer Groups To Congress: Probe Allergan IPR Deal

    A coalition that includes the trade groups for the generic, hospital, health insurance and pharmacy benefit manager industries are the latest to call on Congress to investigate Allergan's deal with a Mohawk tribe to skirt inter partes review of its patents.

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  • Rep. Carter Urges New Approval Path For Non-Opioid Pain Treatments

    Rep. Buddy Carter (R-GA) wants to work with FDA to craft a new approval pathway for non-opioid pain treatments. While his office was unwilling to say whether the pathway would come with new incentives, industry has already been making its case to the White House on why drug makers should be rewarded for creating non-opioid pain medications. Carter is also calling for greater latitude for pharmacists to decide when to partially fill an opioid prescription.

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  • Circuit Remands Portions of Controversial Praluent Patent Case

    A federal circuit judge has reversed a lower court's recent controversial decision to order a biologic cholesterol medication to be taken off the market in response to a patent challenge. While the judge found the decision clearly went against U.S. Supreme Court precedent that requires an injunction not disserve the public interest, ultimately the injunction was pulled because the circuit called for the district court to rehear portions of the underlying patent case.

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  • 57 Senators Urge CMS To Protect 340B, Call For Program Reforms

    More than half of the Senate signed on to a letter asking CMS to make sure proposed cuts to hospitals' 340B drug reimbursement don't affect the long-term success of the program, though the bipartisan group says reforms to the 340B drug discount program are needed.

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  • OMB Reviews Proposed Rule On 340B Ceiling Prices, Manufacturer Penalties

    The White House Office of Management and Budget is reviewing a proposed rule on 340B ceiling prices and manufacturer penalties following the Trump administration's fourth delay of a final rule on the same topic put out by the Obama administration.

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  • Senate Health Committee To Hold Second Rx Price Hearing On Oct. 17

    The Senate health committee will hold the second of three planned hearings on drug pricing and the drug delivery system Tuesday Oct. 17, the committee announced Thursday (Oct. 5).

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  • GPO Analysis: Allergan Patent Deal Could Cost $10.7 Billion In Lost Savings

    Should Allergan's controversial patent deal with the Saint Regis Mohawk Tribe hold up and delay generic competition for Restasis until 2024, the deal would cost the U.S. health care system $10.7 billion in lost savings, group purchasing organization Vizient estimates. But the Allergan CEO says his company's move to dodge the inter partes review (IPR) process, which the company says is unfair, does not mean generics will necessarily be delayed until 2024 -- when the drug's Orange Book-listed patents expire -- just that generic competitors will have to fight Allergan over its patents in federal court.

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  • E&C Dems Praise 340B Providers, GOP Worried By Lack Of Program Data

    House Energy & Commerce Democrats on Wednesday (Oct. 11) touted 340B providers and the programs run off of savings received through that drug discount program, but committee Chair Greg Walden (R-OR) said he was worried about the lack of transparency and dearth of data on how the providers use the program.

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  • Lawmakers Want Beneficiaries To Get Bigger Share Of Drug Rebates

    A bipartisan group of 54 House lawmakers on Oct. 3 asked CMS to force plans and pharmacy benefit managers to give Part D beneficiaries a larger share of rebates, discounts and pharmacy price concessions. Although consumers are the focus of the letter, Pharmaceutical Care Management Association President and CEO Mark Merritt said pharmacies, which are trying to get out of paying discounts, would be the true beneficiaries of the proposed policies. Pharmacies counter that pharmacy benefit managers are charging fees that put pharmacies in the red and aren't passed to beneficiaries.

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  • E&C Oversight Chair Murphy Resigns Amid Panel's 340B, Malware Probes

    House Energy & Commerce oversight Chair Tim Murphy's (R-PA) announcement Thursday (Oct. 5) he will resign this month comes as the subcommittee steps up its probe into the 340B drug discount program and investigates the healthcare industry's response to malware threats. Murphy has also been a staunch advocate for mental health reform and one lobbyist said it is unclear who might take up that mantle.

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  • GOP Lawmakers Ask CMS To Exclude Rx Costs From Doctor Pay

    Specialists are getting help from House Republican lawmakers in their quest to exclude the cost of drugs they administer from the calculation of their Medicare bonuses and penalties. A letter being circulated by Rep. Erik Paulsen (R-MN) urges CMS to change the policy administratively, but lobbyists say the law likely needs to be changed.

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  • Medical Device Cybersecurity Bill Aims To Create Consensus Framework

    A new bill introduced by Reps. Dave Trott (R-MI) and Susan Brooks (R-IN) would mandate the creation of a public-private partnership tasked with recommending to Congress cybersecurity frameworks, standards and guidelines for networked medical devices that can better protect health care information from future cyber attacks. While the device lobby supports the bill, one industry attorney questions whether it would serve a purpose other than to micromanage FDA. A Trott staffer tells Inside Health Policy that while FDA is doing good work addressing cyber threats, a new law would require all parties affected to work together on the issue -- which the staffer says the agency currently cannot do.

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  • Appeals Court To Expedite AAM's Appeal In Maryland Drug Pricing Challenge

    The Fourth Circuit has granted the Association for Accessible Medicines' request to expedite appeal of a district court's recent decision to strike down a constitutional challenge to Maryland's first-in-the-nation generic drug price gouging law. Maryland had urged the appeals court not to expedite review, alleging that AAM's appeal was no more than an attempt to rehash disproved claims.

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