Legislative Update: Week of September 2, 2019

Sep 02, 2019


On Wednesday, the FDA finalized guidance on using placebos for clinical trials. As drafted, “placebos should only be considered in randomized controlled trials to treat oncologic disease or hematologic malignancy “when surveillance is standard of care” or in studies with “certain trial design features” (e.g. when the trial uses an add-on design).” Through this proposal, the agency is working to ensure certain patients with serious medical conditions aren’t subjected to the placebo if there’s a known, effective therapy already on the market.

In Massachusetts, MassBio released its 2019 Industry Snapshot report, which shows the Massachusetts biopharma industry experienced the highest year-over-year employment growth in over a decade. The industry has added 4,300 new jobs since 2017 and nearly 20,000 jobs over the last 10 years – and increase of 35%. The report also found that venture capital in Massachusetts reached an all-time high, totaling $4.8 billion. Download the report to see the full results.

Additionally, Governor Baker demonstrated his interest in learning more about managed lanes to ease traffic congestion at last week’s National Governor’s Association meeting. The Baker Administration will commission a new study to look into whether and how managed lanes will work for Massachusetts, but noted that it is the one that is most likely to come to fruition quickly. In other transportation news, MassDOT tested use of the ramp from South Boston Haul Road to I-90 for silver line buses. By letting the buses bypass some South Boston traffic, the hope is that this ramp will lead to shorter rush-hour rides between downtown and Logan Airport and Chelsea along the silver line routes.


August recess ends for both Congress and state legislators kicking off the fall session with pending legislation around drug pricing.

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