Policy Matters - June 2011

STATE UPDATE

Higher Ed Task Force Recommendations Won the Day in Olympia

On June 7, Governor Chris Gregoire signed two important higher education bills, HB 1795 – the Higher Education Opportunity Act and HB 2088 the Scholarship Opportunity Act, into law. Fittingly, the bill signing took place in a Cleveland High School biology lab. Many of the provisions in both bills were specifically based on recommendations made by the Governor’s Higher Ed Task Force. WBBA President Chris Rivera served as a member of the task force.

HB 1795 sets explicit goals for increased degree production including targets for specific populations and key degree areas; provides short-term tuition setting flexibility for Washington’s public, baccalaureate institutions to help manage current economic challenges; provides increased institutional financial aid to offset tuition increases; and strengthens accountability and performance measures of the colleges and universities.

HB 2088 creates the Opportunity Scholarship Program, a public-private partnership to help low-and-middle income students pay for higher education. The state put $5 million of seed money into the public-private partnership and Microsoft and Boeing have each committed $25 million. The first scholarship awards will be made in December 2011.

WBBA worked closely with a number of allies and legislators to help pass these important bills. Rep. Tim Probst (pictured at left), an exceptional legislator, championed HB 2088 from its rocky beginning to its final passage. “We want to thank Representative Tim Probst for his extraordinary leadership in working with a diverse group of stakeholders to craft a bill that will enable more Washington kids to go to college,” said Chris Rivers, President of the Washington Biotechnology & Biomedical Association. “His tireless effort on the Opportunity Scholarship Act will have both immediate and long term benefits for the citizens of Washington."  Read Press Release: Probst Wins Scholarships for Middle Class: Tens of Thousands of College Scholarships Created in Last-Minute Victory


Governor signing the bill:

 

Microsoft and Boeing pledge $50 million to
jump start the Opportunity Scholarship Program:

South Lake Union Surpasses Life Growth Expectations

On May 27, Mayor Mike McGinn met with stakeholders, including Chris Rivera and Patti McKinnell Davis, to talk about growth in South Lake Union, which exceeded projections on square footage development, lab space, jobs, and tax revenues. Between 2004 and 2010, commercial real estate development activities in South Lake Union were more than double original projections. That resulted in more than 13,000 permanent jobs and an average of $5 million per year in additional tax revenues to the City since 2004. See the South Lake Union Development Update. Mayor McGinn discussed how the city can best support the continued growth of the life sciences in Seattle. He reviewed the Strategic Situation Assessment report and commented on key findings and mayoral commitments on power reliability, code adjustments, environment efficiencies, urban vitality, skilled workforce, and building on success.

More Than a Golf Game

WBBA’s Annual Golf Tournament is the only WBBA event which raises money to support WBBA’s state political action committee, BIOPAC. During the 2010 election year, the BIOPAC made campaign contributions to 53 candidates in both parties. A strong BIOPAC helps increase the life science sector's voice in Washington state government. Join us for more than a golf game at WBBA’s 7th Annual Golf Tournament, Monday, August 15 at Fairwood Golf & Country Club. Don’t miss out. Register today and get the Early Bird rate.

Golf Sponsorship Opportunities Available.  Please contact Patti McKinnell Davis at patti@washbio.org or 206.456.9566.

FEDERAL UPDATE

Temporary Reauthorization of SBIR

On May 31, S.1082, "The Small Business Additional Temporary Extension Act of 2011” passed overwhelmingly to extend SBIR in a Continuing Resolution (CR) through Sept. 30, 2011. While this ensures there will be no gaps in current SBIR programs, there are efforts underway to get SBIR reauthorized for a longer period than that provided by a CR.

Patent Reform

While the Senate overwhelmingly passed the patent reform bill, S. 23 “America Invents Act” in March, the House has yet to pass a patent reform bill. The House bill is expected to be on the floor for action soon.

“FDA Impact on U.S. Medical Technology Innovation”

Dr. Josh Makower surveyed more than 200 medical device companies for his report on the “FDA Impact on U.S. Medical Technology Innovation.” According to the study, overwhelmingly, U.S. medical device and diagnostics companies are going to Europe first to get regulatory approval for their products. Companies report that the regulatory process in Europe more predictable and transparent that that of the FDA. The result is that American patients have access to new life-saving or life-enhancing products and therapies as much as two years after European patients. In addition to patient access, the report details the economic implications for the U.S. Read more.

FDA Reform – WBBA Medical Device Members Call for Transparency, Certainty and Accountability

During a meeting with Congressman Inslee while at the AdvaMed Fly In, he requested input from our medical device companies regarding needed improvements at the FDA. The comments and recommendations from our members call for increased transparency, an end to regulatory uncertainty, and agency accountability.

Increase Transparency

  • Include direct industry involvement in the drafting of FDA guidance documents to describe the requirements for 510 (k) product clearance submissions.
  • Increase transparency in the status of FDA premarket reviews of product submission.
  • Increase transparency and stakeholder involvement in implementation of FDA policies. Implementation must first be preceded by the publication of the details associated with them, and the public must then be provided sufficient time for public comment to the FDA prior to implantation, regardless of whether the reform/change is being implemented using a guidance document, a regulation or legislation.

End Regulatory Uncertainty

  • Make regulatory pathway definitions clear.
  • When FDA gives formal approval and sign off on a clinical study, and a company successfully completes the study as agreed, the company must be able to rely on that information.
  • Streamline the FDA De Novo 510 (k) product review process for devices without clear predicates to compare performance to. Eliminate the need to submit a 510 (k) and have it rejected due to lack of a predicate devices before the de novo process can be started.

Require Accountability

  • Report racking of agency performance to target timeframes.
  • FDA should be bound by agreements that that they enter into with a company regarding the pathway to approval.
BIO Says It’s Reached Agreement with FDA on User Fees

“Major hurdle is cleared for PDUFA renewal, which must still get sign-off from White House and move through the legislative process.  Trade groups representing the pharmaceutical and biotechnology industry have reached an agreement with the U.S. Food and Drug Administration over renewal of legislation that will continue to allow the agency to collect user fees from companies seeking marketing approval for their products.”  Read More | www.bio.org

Extending the Therapeutic Discovery Project Tax Credit

Representatives Susan A. Davis (D-CA) and Allyson Y. Schwartz (D-PA) recently introduced legislation that would extend the Therapeutic Discovery Project. The bill would accelerate the development of life-saving cures for numerous prominent diseases, such as cancers, mental illnesses, heart disease and Parkinson's disease.

FDA STUDY- National Academies Press (NAP) Offers Free PDFs Versions of Published Books

As of June 2, 2011, all PDF versions of books published by the National Academies Press are downloadable free of charge to anyone. This includes a cataglog of more than 4,000 books. NAP is the publisher for the National Academy of Sciences, National Academy of Engineeering, Institute of Medicine and the National Research Council. Check it out - it's free.
http://notes.nap.edu/2011/06/02/more-than-4000-national-academies-press-pdfs-now-available-to-download-for-free

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