Legislative Update: Week of June 28, 2021

Jun 28, 2021

LAST WEEK

Last week, 295 representatives from biotechnology companies and associations across the globe, including MassBio and 34 Massachusetts companies, signed on to the CEO Declaration on Access to COVID-19 Vaccines and Treatments and the Role of Intellectual Property in response to the Biden Administration’s decision to support the World Trade Organization’s (WTO) proposed waiver on intellectual property rights. The declaration outlines the numerous measures through which the industry is working to ensure that COVID-19 vaccines and treatments are accessible to all patients and why the waiver is detrimental to the future of innovation.

On Tuesday, U.S. House Representative Diana DeGette, Chair of the House Energy and Commerce Oversight Subcommittee, and Representative Fred Upton released draft legislation on “Cures 2.0” which seeks to improve on the 21st Century Cures Act. As outlined, the legislation includes a provision to create an Advanced Research Projects Agency for Health (ARPA-H), based upon President Biden’s proposal to create a research agency to find cures for the world’s most difficult diseases (ARPA-H Fact Sheet). The legislation also includes measures to increase diversity in clinical trials, require the FDA to expand collection and use of real-world evidence, and improve Medicare coverage for innovative new treatments and technologies. And on Wednesday, a group of U.S. Senate Republicans introduced the “Lower Costs, More Cures Act.” According to the release, the legislation seeks “to lower prescription drug prices, bring greater transparency to the prescription drug industry, and encourage American ingenuity in the development of new treatments and cures.” Among other measures, the legislation would require drugs with a wholesale acquisition cost (WAC) exceeding $100 to publish “certain information regarding any price increase equal to or exceeding 10 percent in a single calendar year or 25 percent or more in three consecutive calendar years;” and gives the Department of Health and Human Services the authority to require manufacturers to include pricing information in all direct-to-consumer advertising.

And in Massachusetts, the House and Senate voted against Governor Baker’s $2.8 billion spending plan and instead proposed putting $4.89 billion into a COVID-19 relief fund and directed Governor Baker to spend $200 million “to protect against emerging public health threats or to support new, heightened, or emergency public health response efforts against the 2019 novel coronavirus.” The proposal is currently with Governor Baker, awaiting further action.

THIS WEEK

On Monday, the Massachusetts state legislature passed an interim $5.41 billion budget to keep the government funded beyond the July 1 start of the new fiscal year and through July while deliberations over the fiscal year 2022 budget continue.

On Thursday at 10am, Massachusetts’ Joint Committee on Financial Services will hold a hearing focused on health insurance and banking matters. Of interest to the life sciences, the Joint Committee will hear testimony on House Bill 1201, an act ensuring access to medications; House Bill 1155, an act to ensure access to generic medications; House Bill 1202, an act to ensure access to generic medication; and Senate Bill 664, an act ensuring access to medications. Online sign up to testify will be available until Tuesday, June 29 at 5pm and online testimony will be accepted until Thursday, July 8.

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