• Congress is considering a massive and much-lobbied piece of legislation, the 21st Century Cures Act, with big implications for pharma – and for digital health players as well. The “Christmas tree” bill would:
    • Speed up FDA approvals and fund some major medical research initiatives, including the Obama Administration’s Cancer Moonshot and Precision Medicine Initiatives;
    • Require that FDA address the use of real world evidence data for postmarketing studies, additional indications and label expansions;
    • Establish a regulatory safe harbor for some clinical decision support tool developers
  • Earlier versions would also loosen reporting requirements for physician-pharma contacts, the so-called Sunshine Act provisions, though this provision has reportedly been stripped out. The bill flew through the House yesterday, but has been assailed by the Warren/Sanders wing of the Democratic Party and may face tougher sledding in the Senate. Some physicians have also criticized the legislation, saying it dilutes the FDA’s authority and weakens public safety.


  • President-Elect Trump signaled an interest in going beyond repealing the Affordable Care Act to make big changes to Medicare and Medicaid. His selection of arch-conservative surgeon-turned-congressman Tom Price (R-GA) to head Health and Human Services suggests he’s on board with Republican plans to privatize Medicare and block-grant Medicaid, as does his tapping Republican policy consultant Seema Verma, who has negotiated ACA Medicaid expansion plans on behalf of state Republican administrations, including that of incoming VP Mike Pence.


  • The AMA approved a policy calling for value-based drug pricing as determined by an independent agency through a transparent, evidence-based process. AMA president Dr. Andrew Gurman said in a statement that “the carte blanche approach to drug pricing needs to change to align with the health system's drive for high-quality care based on value.”


  • FDA is proposing a study that suggests it’s reconsidering guidance prohibiting drug marketers from making product claims in space-constrained media and fulfilling fair balance with a link to risk information. The study, tentatively titled “Character-Space-Limited Online Prescription Drug Communications,” aims “to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about that drug are made within character-space-limited communications used in prescription drug promotion.”


  • Alphabet/Google and Novartis’ Alcon are pushing back testing a smart contact lens, one of two they have in development, and offering nothing in the way of a timeline. There have been conflicting signals on the state of this project – a trash-talking insider told Stat that the lens was nothing but “Slideware,” but Novartis’ CEO earlier projected confidence and said an autofocusing lens for presbyopia patients could go into clinical trials in 2016.





  • An innovative global dementia study draws on data from the 2.4 million players of a mobile gameSea Hero Quest, designed to test spatial navigation and memory skills. Among the initial findings: spatial navigation worsens steadily after you turn 20, and that people from coastal countries, including the Nordic nations, Australia and New Zealand, perform best.


  • Some good news on the dementia front: researchers reported a surprise drop in the share of elderly Americans with dementia, which fell from 11.6% to 8.8% from 2000 to 2012. This could mean fears of a Boomer Alzheimer’s glut don’t bear out, but raises the urgent question of why the rate of old folks with dementia is improving. One theory is that today’s aging population is better-educated, meaning that our elders have more “backup synapses and neurons” and so are better cushioned against neurological decline.


  • However, Lilly’s great hope for an Alzheimer’s breakthrough, solanezumabfailed to meet its endpoints in a closely-watched phase 3 clinical trial for treatment of mild dementia, casting doubt on a number of treatments aimed at clearing up the amyloid plaques associated with the disease.



  • Oscar Insurance, whose launch was predicated on the ACA’s individual insurance marketplaces, faces an uncertain future with the law set to be gutted, despite the involvement of some Trump-connected figures.


  • GE Healthcare is partnering with the NFL for a telemedicine pilot that will provide concussion diagnostics to around 50 student athletes at 19 rural Texas school districts, via Houston Methodist Hospital’s concussion center. Coaches will first run students with suspected concussions through a tablet-based assessment app and then Skype a physician at the hospital for evaluation.




“Interested in hearing more expert analysis on the healthcare implications of the outcome of the 2016 U.S. election? Register for our live webinar, taking place on Thursday, January 19, 2017 at 10 a.m. EST, and receive a complimentary ebook with key take-aways.”

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