|Dear MassBio Member,|
It was a very busy week for policy both at the federal and state level and we'd like to share some information with you. Thank you for your continued support of the MassBio policy strategy, and for your ongoing engagement in the issues which are of vital importance to our industry.
Supreme Court Upholds Affordable Care Act
Just yesterday, the Supreme Court of the United States upheld the federal Affordable Care Act, including the proposed pathway to biosimilars. Read the decision online.
MassBio will continue to work with the members of the Massachusetts delegation, as well as state and federal agencies to ensure that the law - when finally implemented in 2014 - will positively impact patients who are in need of innovative therapies, many of which are made right here. Our focus will continue to be on ensuring federal policy protects innovation and serves guarantees patient access to the most cutting-edge treatments and cures.
MassBio's Law & Policy Committee is hosting a conference call to discuss the ruling on Monday. Find out more and register to join.
Small Business Administration Proposes Changes to SBIR/STTR Program
On May 15th, the Small Business Administration issued a proposed rule implementing statutory changes in the SBIR/STTR programs. That started the clock ticking on the 60 day public comment period which ends on July 16, 2012.
The proposed rule is the next step in ensuring that companies that are majority owned by venture, private equity or hedge funds are eligible for SBIR & STTR funding. Download a summary of the proposed changes.
We are encouraging all MassBio members to submit personal comment directly to the SBA. While we will weigh in on behalf of our members as a whole, individually submitted comments help show the SBA the breadth of our engagement.
To comment go to www.regulations.gov (RIN 3245-AG46).
PDUFA Reauthorization Secured Through Passage of Food and Drug Administration Safety and Innovation Act (FDASIA)
Earlier this week, the Senate passed the Food and Drug Administration Safety and Innovation Act (FDASIA), which included reauthoriziation of the Prescription Drug User Fee Act set to expire in September.
We are pleased to report that FDASIA will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review. It will also increase the Food and Drug Administration's (FDA) access to external expertise to improve the drug review process.
The enhanced Accelerated Approval pathway will help expedite the development of personalized therapies for patients suffering from serious and life-threatening diseases while preserving the FDA's robust standards for safety and effectiveness.
Click here for more on FDASIA and PDUFA.
Massachusetts State Legislators Advance Co-Pay Assistance Legislation & Gift Ban
The FY2013 Budget Conference Committee report was released Wednesday, and includes language to allow for co-pay assistance programs in Massachusetts. The report also includes a provision to allow certain interactions between companies and physicians currently barred under the "gift ban" previously enacted.
MassBio continues to review the report and understand its implications. We will advocate for industry priorities as the budget now moves to Governor Patrick's desk.
Watch a brief press conference with Conference Committee chairmen Rep. Dempsey and Sen. Brewer.
Thanks again for your continued advocacy, and stay tuned for details as we close out both the federal and state legislative sessions.
Robert K. Coughlin
President & CEO