In this issue...
Love to golf? Want to get involved with the planning and execution for one of WBBA’s short-term yet critical committees? Our golf event, held this year on August 13 at Fairwood Golf & Country Club, raises money for BIOPAC, WBBA’s political action committee. If you’d like to get involved, join us on the WBBA Annual Golf Invitational Committee for 2012. The committee kicks off in April. Come have some fun and help raise WBBA’s voice in Olympia. You just have to be a member to participate. Contact Darcy Jacobson for more information.
Would you like to be involved in the WBBA’s educational programming for the year? If so, join us on the WBBA Program Committee! The committee meets monthly to discuss and refine the programming the WBBA brings you each year. You just have to be a member to participate. Contact Darcy Jacobson for more information.
WBBA invites its members to take part in one or more of several new groups that are being formed. Learn more here.
WBBA Testimony on SB 5808
Thank you to Senators Jim Kastama and Rosemary McAuliffe for sponsoring the Innovative Industries for Economic Development Enabling Act (SB 5808) which would create a self-financing grant funding mechanism to provide an opportunity for WBBA to further expand current efforts around commercialization, exporting and other industry identified needs. On January 19, Chris testified on behalf of WBBA and its members in support of the bill before the Senate Economic Development, Trade and Innovation Committee. On February 27, executive action in Senate Ways & Means resulted in recommendation of do pass and the bill was referred to the Rules Committee for second reading.
WBBA Testimony on SB 5735
Thank you to Senators Maralyn Chase, Jim Kastama, Derek Kilmer, and Rosemary McAuliffe for sponsors the Encouraging Economic Development by Removing the Expiration Date from the Research and Development Business and Occupation Tax Credit (SB 5735). The R&D tax credit is one of the few competitiveness incentives available to the life sciences industry in Washington. On January 23, Patti McKinnell Davis testified on behalf of WBBA and its members in support of the bill before the Senate Economic Development, Trade and Innovation Committee. The last action on the bill took place on January 27 when it was referred to Senate Ways & Means.
BIOPAC – WBBA’s Political Action Committee Needs Your Support
Thong Le, WBBA’s Board Chair and Erik Nilsson, WBBA’s Government Affairs Council chair invite you to join them in contributing to BIOPAC, the WBBA’s bipartisan political action committee. BIOPAC helps elect candidates and promote issues that improve the Washington life sciences business and innovation climate. In 2012, Washingtonians will elect a new Governor, half of the state’s Senate, and all of the state’s House of Representatives. The next few years will bring legislative battles that are critical to our life sciences industry. It is important for us to have a strong voice in these matters that will affect the quality of life for all Washingtonians. Please join them in making a personal contribution to BIOPAC and demonstrate your commitment to a stronger biotech sector in Washington.
Washington Life Sciences Represented at White House Business Council Conference
WBBA members Monty Montoya, President and CEO, SightLife; Brian Glaister, President and CEO, Cadence Biomedical; and Anson Fatland, Associate Vice President of Economic Development, Washington State University as well as Patti McKinnell Davis, WBBA Director Public Affairs, represented the Washington life sciences at a White House Business Council in Washington DC on February 9, 2012. Among other topics there was a chance to discuss FDA reform, research funding, access to capital, and SBIR loans.
Letter Calls for Preservation of Biosimilar Data Exclusivity Period
Four members of Washington’s federal delegation joined on to a bipartisan letter to President Obama regarding the Biologics Price Competition Act, known as the Pathway for Biosimilars in the House. The Act established a 12-year period of data exclusivity for innovator biologics and was included in both the House and Senate versions of health reform and signed into law. Special thanks to Representatives Jay Inslee, Cathy McMorris Rodgers, Dave Reichert and Adam Smith for their support on this issue then and now. Read more.
FDA Releases Guidance on Biosimilar Product Development
On February 9, the U.S. Food and Drug Administration (FDA) announced it had issued three draft guidance documents on biosimilar product development. On February 15, the FDA held a webinar on biosimilar products. The presentation notes can be found here.
For more information:
WBBA Members Represented at AdvaMed Legislative Fly In
WBBA represented our medtech members as part of the recent AdvaMed Legislative Fly In. While in Washington DC, Patti McKinnell Davis was able to meet with staff from every Washington Congressional office except one. There were two top policy objectives - passage of MDUFA and repeal of the medical device excise tax. See below.
FDA and Industry Reach Agreement in Principle on MDUFA
The new Medical Device User Fee Agreement directly addresses a number of issues about which WBBA members have spoken out. Med tech leaders and the FDA worked together to develop an agreement intended to improve FDA performance and provide accountability and predictability. Read more.
Movement to Repeal the Medical Device Excise Tax
The Affordable Care Act, signed into law in 2010, included a $20 billion medical device excise tax. The tax takes effect in 2013, regardless of whether the company is profitable or not. WBBA has been working with AdvaMed and MDMA, national medical device associations, to repeal the tax. Between the House and the Senate there are currently five repeal bills. The “Protect Medical Innovation Act of 2011” (HR 436.IH) has 228 co-sponsors including two of Washington’s Congressional Representatives Cathy McMorris Rodgers and Dave Reichert. There is the possibility of a vote in the House.
In the meantime, the IRS website states: “On February 3, 2012, the IRS and the Treasury Department issued proposed regulations on the new 2.3-percent medical device excise tax (IRC §4191) that manufacturers and importers will pay on their sales of taxable medical devices starting in 2013. Additional information is available in the Medical Device Excise Tax FAQs. The IRS and Treasury Department request comments on the proposed regulations by May 7, 2012. Comments may be submitted electronically, by mail or hand delivered to the IRS. The preamble to the proposed regulations provides instructions on how to submit comments.”
Patent Legislation and Satellite Office Update
In related news, WBBA has been an active partner in Seattle's efforts to become a site for a regional satellite patent office. Read more here.