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April 14, 2016, Covington Alert
It has now been a full year since the Food and Drug Administration (“FDA”) approved the first biosimilar product to proceed under the new abbreviated biological pathway. With recent spotlights on the cost of pharmaceutical drug products, the potential of biosimilars to offer patients additional and more affordable choices has been widely discussed. Most recently, the Department of Health and Human Services’ 2017 Budget in Brief noted that the first approval under the abbreviated pathway could be the “next step to increasing treatment options for patients.” As the U.S. landscape continues to evolve, below are the top ten things to know about the reimbursement developments in the last year.
November 4, 2016, FDA Week
Michael Labson spoke at the FDLI Annual Advertising Conference and is quoted in an FDA Week article regarding communication between drug makers and payers under a section of the FDA Modernization Act. According to Labson, first amendment jurisprudence may make concerns over FDAMA 114 a non-issue. "If the first amendment idea that you have a constitutional right ...
2016, American Health Lawyers Association
October 7, 2015, Covington Alert