Pfizer and BioNTech announced on Friday that they applied for emergency use authorization (EUA) of its COVID-19 vaccine. The companies announced a few days prior that the final trial results of their COVID-19 vaccine candidate was 95% effective in preventing COVID-19 with no major safety concerns. The FDA responded by scheduling an Advisory Committee meeting on December 10th to discuss the request. Pfizer has said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.” Also on Friday, the FDA approved for emergency use Regeneron’s antibody cocktail for COVID-19.
On Wednesday, the Massachusetts State Senate voted 40-0 to pass its version of the FY2021 budget. The final budget did not include the amendment language offered by Senator Boncore to extend the copay assistance sunset to 2023. In the coming days a conference committee will be appointed to iron out the differences between the House and Senate budgets and send the final Conference Committee Report to Governor Baker.
As mentioned in last week’s legislative update, the Massachusetts Health Policy Commission (HPC) held a board meeting on Wednesday. Of interest to the life sciences industry are slides 34-44 of the presentation, which highlight the MassHealth and HPC drug pricing review process and outline sample review questions and data sources that HPC plans to use when assessing a drug’s value. Additionally, on Monday night, an order was introduced during the Cambridge City Council meeting that aims at “Restricting Indoor Activities,” shutting down all non-essential businesses in the City. Discussion on this order will take place at their next Council Meeting on Monday, November 23.
In Federal news, Congresswoman Katherine Clark, representing the 5th District of Massachusetts, was elected to the role of Assistant Speaker of the U.S House of Representatives – the fourth highest ranked position of House leadership in Congress. MassBio President & CEO Bob Coughlin issued the below statement on the election:
“MassBio congratulates Congresswoman Katherine Clark on being elected by her fellow Democrats to the position of Assistant Speaker of the U.S. House of Representatives. Congresswoman Clark has always been a champion of the life sciences industry, dating back to her days serving as a member of both the House and Senate in the Massachusetts Legislature. Representing a district with a large life sciences presence, she knows first-hand how important the industry is to the Commonwealth’s economy and job creation, but more importantly, she understands the vital role it plays in improving patient lives and bringing hope to those with unmet medical needs. Even more, Congresswoman Clark is a true collaborator. Now more than ever, industry and government need to work together to foster innovation and tackle our toughest medical problems and I look forward to working with her in this new role.”
The Trump administration announced two final rules expected to lower drug prices. The first would end rebates made between drug manufacturers and pharmacy benefit managers (PBMs) for Medicare and Medicaid managed care and redirect those discounts towards patients. The second rule pertains to the Trump Administration’s “most favored nations” policy which would tie prescription drug prices in Medicare to those in international, developed countries and was announced as an interim final rule enabling the Trump Administration to bypass normal regulatory processes and forgo additional public comment before going into effect immediately. MassBio President & CEO Bob Coughlin released the below statement on the interim final rule:
“In his final weeks in office, President Trump is punishing the biopharma industry and patients across the U.S. by impulsively filing half-baked, legally questionable, and extremely harmful drug pricing regulations that seek to lower costs in Medicare, but in reality will limit patient access to breakthrough therapies and distract the incoming Administration from critical public health priorities. Not only have Trump’s economic advisors stated that foreign price controls such as his Most Favored Nation policy in Medicare will result in as many as 100 fewer medicines developed over the next decade, this policy is also being forced through via an Interim Final Rule during a time when America’s biopharmaceutical industry is leading the fight against the COVID-19 pandemic and overcoming all odds to develop and manufacture a successful vaccine in record speed. We’ve all experienced the unbelievable role biopharma innovation plays in both public health and the economy and I urge Republicans and Democrats to stand together and reject these price controls that will hamper the industry’s ability to continue investing in life-savings therapies for future generations.”
In Massachusetts on Monday, the House and the Senate appointed members to a conference committee to iron out the differences between the House passed and Senate passed versions of the FY2021 budget. The House named Reps. Michlewitz, Garlick, Smola, and the Senate named Sens. Rodrigues, Friedman, O’Connor. The current interim FY2021 budget funding expires near after Thanksgiving so there is time pressure on the conference committee to reach consensus quickly and send a final budget to the Governor for his review.