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FDA Week - 12/15/2017

  • FDA Seeks To Make Prescription Drugs Available OTC, With Conditions

    FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

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  • Advocates Hike Calls For CMS To Keep In-Line Policy, States Offer Enrollment Extensions

    Beneficiary advocates Thursday continued to call on CMS to extend the open enrollment period or at the very least employ a special enrollment period that would allow consumers who started the application process but were unable to finish by the Dec. 15 deadline to enroll in a plan.

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  • FDA Seeks To Make Prescription Drugs Available OTC, With Conditions

    FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

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  • FDA Plans Meeting On 'Unprecedented' Steps To Combat Opioid Crisis

    FDA will hold a meeting Jan. 30 weighing a number of steps FDA Commissioner Scott Gottlieb called unprecedented to deal with the opioid crisis, including requiring sponsors create nationwide Prescription Drug Monitoring Programs (PDMPs). Other proposals to be aired at the meeting include mandating additional prescriber documentation when prescribing opioids above a certain threshold, potentially imposing additional measures to improve patient storage and handling of opioids, and the possibility of requiring sponsors create mandatory opioid take-back programs.

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  • PhRMA Throws Support Behind Opioid Prescribing Limits

    Drug industry lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) on Monday (Dec. 11) threw its support behind a number of policy proposals to tackle the opioid crisis, including limits on prescribing, a ban on prescribing of Schedule II opioids in an office setting, ongoing prescriber training, expanded access to addiction treatment options, and development of abuse-deterrent formulations (ADFs) of opioids.

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  • Both Generics, Brands Question Plan To Publish REMS Protocol Letters

    Neither the brand nor the generic drug lobby appear keen on FDA Commissioner Scott Gottlieb's idea to publish the letters it sends to brand companies explaining that a potential generic competitor has adequate safety protections in place to be sold brand drug samples for the bioequivalence testing required as a prerequisite of generic approval. Generics worry the letters could lead to competition problems, while brands worry the letters without the proper context could soil their reputation.

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  • FDA To Develop Reg Framework For 3D Printing, Expert Predicts Pushback

    FDA Commissioner Scott Gottlieb on Monday (Dec. 4) announced the agency will establish a regulatory framework for how it regulates nontraditional manufacturers of 3D-printed medical devices. But one expert expects FDA to face pushback from these newly regulated entities, like university hospitals already making these devices in emergency situations, because of the perceived drag on flexibility and higher costs associated with greater regulation.

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  • CSPI, Pew Upset By FDA Move To Scrap Agency's Only Food Advisory Panel

    Two public health groups are upset over FDA's decision to terminate the agency's only food advisory committee, with the Center For Science in the Public Interest calling the decision "further evidence of the low value this administration places on independent scientific advice." One food policy expert told Inside Health Policy that while FDA had not convened the committee in two years, the panel could have played a role in nearly all of FDA's major food-policy initiatives, including nutrition facts labeling, food additive policies and implementation of the Food Safety Modernization Act, including the produce rule.

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  • FDA Sees Increase In Use Of Patient-Reported Outcomes For Devices

    FDA from 2008 to 2014 saw a roughly 500 percent increase in the number of premarket submissions that include patient-reported outcome (PRO) measures, but there are still challenges the agency needs to tackle when it comes to incorporating PROs into device approvals, including enhancing training, transparency and expertise, and reducing sponsor uncertainty, according to the agency's first PRO report released Tuesday (Dec. 12).

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  • Lawmaker Pushes Gottlieb To Address Off-Label Uses Of Non-Opioids

    One lawmaker is upset FDA has yet to provide him details on how the agency will address use of unapproved non-opioid products and off-label uses of non-opioid products for acute and chronic pain treatment. The lawmaker also wants answers on what FDA has done to address non-opioid drug shortages.

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  • PhRMA Challenges Constitutionality Of Calif. Drug-Price Transparency Law

    Brand drug makers on Friday (Dec. 8) challenged the constitutionality of a California drug-price transparency law. The lawsuit by the Pharmaceutical Research and Manufacturers of America argues the law violates numerous constitutional provisions, including the Commerce Clause, the First Amendment and the Fourteenth Amendment's Due Process Clause, and it raises concerns the law would set national pricing policy.

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  • AAM To FDA: Be Harder On Brands Manipulating REMS

    The Association for Accessible Medicines wants FDA to exert greater pressure on brands thought to be manipulating Risk Evaluation and Mitigation Strategies (REMS) to block generic competition. The group suggests the agency condition approval of REMS drugs on the sponsor agreeing to make samples available to all future competitors, state that a brand's failure to provide samples within a period of time will be deemed a violation of the REMS, and take enforcement action against brand companies that manipulate REMS to block or delay generic entry.

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  • HHS To Distribute Opioid Funds Based On Population, Not Need, In 2018

    Next year the administration will continue to divvy up set-aside funds for states to fight the opioid epidemic based on a state's population, rather than need, Assistant Secretary for Mental Health and Substance Use Elinore McCance-Katz told senators Wednesday (Dec. 13). Lawmakers from both sides of the aisle have been pushing the administration to change the policy next year when the second year of 21st Century Cures funding kicks in so that states disproportionately affected by the epidemic could better respond, but McCance-Katz said changing funding methods could place extra burdens on states.

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  • Left With Unanswered Questions, E&C Might Hold Another Rx-Price Hearing

    Representatives of the drug-distribution sectors argued over the causes of drug prices at a House Energy & Commerce health subcommittee hearing Wednesday (Dec. 13), but lawmakers were left with unanswered questions and committee Chair Greg Walden (R-OR) said the subcommittee will likely hold another hearing on drug prices early next year.

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  • Paul Proposes Letting Rx Makers Vary Discounts To Move Away From Rebates

    Sen. Rand Paul (R-KY) on Tuesday (Dec. 12) proposed letting drug companies offer varying up-front discounts because doing so would move industry away from rebates that are blamed for obscuring business deals many lobbyists and policy analysts say contribute to price increases. Paul said allowing discounts directly from the manufacturer is a way to achieve price transparency without mandating it.

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  • 340B Policies In The Mix For Possible Inclusion In End-Of-Year Legislation

    A bipartisan group of six senators recently urged the upper chamber's leadership to include a provision to prevent a cut to hospital reimbursement for 340B drugs in an end-of-the-year package -- though it is unclear what legislation lawmakers may look to pass once the current continuing resolution runs out Dec. 22. A hospital lobbyist says that some type of spending bill will need to move once the short-term government funding runs out, and hospitals hope a moratorium on the cuts to 340B hospital pay will be attached to that vehicle.

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  • W&M Bills Would Reduce, Delay ACA Taxes; Pause Employer Mandate

    House Ways & Means Republicans on Tuesday (Dec. 12) introduced a package of bills that would delay the Affordable Care Act's medical device tax by five years, reduce the tax on health issuers that are able to rebate consumers in 2018 and provide full relief to all issuers in 2019, stop implementation of the employer mandate, push the start date for the controversial Cadillac tax by one year to 2021, and freeze for two years the ban on using consumer-directed accounts to purchase over- the-counter medications.

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  • Pallone Pushes Walden To Hold An E&C Hearing On CVS-Aetna Merger

    House Energy & Commerce ranking Democrat Frank Pallone (NJ) on Tuesday (Dec. 5) asked committee Chair Greg Walden (R-OR) to hold a hearing on CVS Health's plan to purchase Aetna for $69 billion because, he said, the merger would be a new frontier for the health industry and it has the potential to either benefit or harm consumers.

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  • FDA Approves First Follow-On, Fast-Acting Insulin

    FDA approved Monday (Dec. 11) the first fast-acting insulin to go through the abbreviated 505(b)(2) pathway, Sanofi-Aventis U.S.'s Admelog, a follow on to Lilly's blockbuster Humalog. FDA Commissioner Scott Gottlieb praised the approval as a step forward for drug pricing, but how significant of a price cut the product will take relative to its competitor and whether Admelog will be interchangeable with Humalog is unclear.

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