This has been another week with persistent advocacy for full repeal of the Medical device tax in standalone legislation. A permanent repeal of the medical device excise tax remains a top priority for CBSA and Colorado's medtech innovators. While we are appreciative of temporary relief through the two- year suspension as part of the Continuing Resolution to fund the federal government, that abatement is set to expire on December 31, 2019.  

Board of Directors to Begin National Search for Replacement 

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CBSA continues to advocate for a full repeal of the Medical device tax in standalone legislation. A permanent repeal of the tax remains a top priority for CBSA and Colorado's medtech innovators. While we are appreciative for temporary relief through the two-suspension as part of the Continuing Resolution to fund the federal government, the suspension is set to expire on December 31, 2019. 
 

This week Colorado BioScience Association along with AdvaMed, our Board Chair Scott Larson at Terumo BCT, Zimmer Biomet and ResMed met with Congresswoman DeGette. The meeting offered a great opportunity to talk about the importance of our industry and the exciting innovations taking place, as well as barriers presenting current challenges.  

2018 COLORADO PRIMARY ELECTION
 

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Denver-based dental instrument company, Sapphire Technology, recently completed a nationwide distribution agreement with Burkhart Dental Supply (Tacoma, WA). Burkhart will soon market and sell Sapphire’s innovative and proprietary line of SGS® sapphire-tipped composite dental instruments. Established in 1888, Burkhart is one of the oldest and most established distributors of dental products. The SGS® instruments are intended to work correctly and ideally with dental restorations employing composite resin restoration materials – now the most prevalent dental restoration material. In addition to acquiring Burkhart as a distributor, Sapphire received a European Patent for its dental instruments. Sapphire was also issued a 2nd US patent.  

Packaging Compliance Labs, a top medical device and pharmaceutical packaging engineering and validation firm, recently opened a new office in the heart of downtown Denver, Colorado, to accommodate rapid growth and leverage the area’s growing biotechnology industry.  

The FDA recently announced the release of important guidances, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers,” and “Medical Product Communications That Are Consistent With the FDA-Required Labeling”. The first guidance answers common questions about companies’ communications to payors, including insurance companies, formulary committees and similar entities. The second guidance provides the FDA’s views on manufacturers’ communication of information that is not contained in the FDA-required labeling for their products, but that is consistent with that labeling. Both guidances are critical to outline how companies can communicate off-label health care economic information about their products to health plans, hospitals and other drug purchasers.  

This week HHS Secretary Alex Azar appeared in front of the Senate Health, Education, Labor and Pensions Committee for a hearing on drug pricing. Secretary Azar’s prepared testimony in large part summarized President Trump’s blue print. For more information on the blueprint click here and to view the full hearing click here. 
 

Annual Bioscience Colorado Magazine Profiles Leaders, Incubators and Ecosystems 

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