Health Care Reform Heats Up on Capitol Hill and So Does BIOCOM’s Work There
Responding to the needs of our members, BIOCOM has initiated a significantly increased presence in Washington DC.
This month, BIOCOM President and CEO Joe Panetta visited with members of the House and Senate in Washington DC. Joining him were International Stem Cell's Jeffrey Janus, and Mpex Pharma's Dan Burgess, who brought our industry's perspective to the nation's capital. Adding to BIOCOM's collaboration this month was Amylin Pharmaceutical's Senior Director of Government and Policy Bill Franco, and Vice President of Public Policy Todd Gillenwater of CHI. BIOCOM partners at BIO, PhRMA and DLA Piper's Gary Klein were also included in strategy and development.
Joe Panetta and the BIOCOM team had personal meetings with Sen. Diane Feinstein, Reps. Susan Davis, Lois Capps, Wally Herger and Duncan Hunter. They also met with legislative aides in the offices of Reps. Anna Eshoo, Linda Sanchez and Dennis Cardoza.
The BIOCOM team voiced concerns over comparative effectiveness, which if done incorrectly could potentially be used to mandate cookie-cutter approaches to treatment or to deny coverage based on cost rather than clinical effectiveness and patient outcomes.
BIOCOM also reminded members of the House and Senate of the agreement (S 1695) that was reached by Chairman Kennedy, Enzi, and Hatch in 2007 based on 12 years of data exclusivity (which BIOCOM supports), and the importance of maintaining that agreement. The group also explained how the industry was up against efforts to reduce the terms of a follow on biologic's pathway to as low as zero to nine years of non-patent data exclusivity in the healthcare reform mark-up that was underway at HELP. They worked to recruit members of Congress to sign onto the Eshoo, Insley, and Barton biosimilars legislation and help fend off attempts by Rep. Henry Waxman to reduce exclusivity to just a few years.
The following three letters outline some of the discussion that took place this month:
Click here to view a joint BIOCOM-CHI letter to Senator Diane Feinstein
Click here to view Senator Diane Feinstein's letter to Senators Kennedy and Dodd.
Just a week later, on the evening of Monday July 13, the Senate health committee voted to add to its health reform bill a follow-on biologics provision that would grant brand-name biologics 12 years of non-patent data exclusivity.
BIOCOM is pleased its Washington DC public policy initiative is having a positive impact on innovation and investment in the life sciences industry. Please contact Madeleine Baudoin at MBaudoin@BIOCOM.org if you are interested in joining the BIOCOM team when they return to Washington D.C. next month.
Increased SBIR Funding for Small VC-backed Firms in the Works
On July 8, 2009 the House of Representatives approved thereauthorization of the Small Business Innovation Research (SBIR)program via the Enhancing Small Business Research and Innovation Act of2009 - H.R. 2965 witha 368-41 vote. On July 13, 2009, the Senate voted unanimously toreauthorize their version of the SBIR and Small Business TechnologyTransfer (SBTT) programs by approving the same bill, but only afterinserting amendments reflective of S. 1233.
The House version of H.R. 2965 reauthorizesSBIR/STTR through 2011 and would open the door to allow VC-backed smallbusinesses to compete and apply for SBIR and STTR grants if no morethan 50 percent of the company is owned by one venture firm and nosingle venture capital company constitutes a majority of the firm'sboard. The legislation also increases early stage Phase I grant funding$150,000 capping it at $250,000 and Phase II funding would be increasedfrom $750,000 to $2 million.
The Senate’s approved versionof the same bill number reauthorizes SBIR and STTR through 2023 andwould let the NIH award up to 18 percent of its SBIR dollars tocompanies that are not majority owned or controlled by a single venturefirm, while the remaining ten (10) federal agencies participating inthe program could apply 8 percent of SBIR grant money to those smallbusinesses. Furthermore, the Senate legislation only increases Phase Ifunding $50,000, capping early stage funding at $150,000. Later stagePhase II funding would be increased from $750,000 to $1 million.
Thelegislation will now go to a conference committee of the House andSenate, where the differences between the House and Senate versions ofthe bills will be negotiated and a consensus can hopefully be reached.We at BIOCOM are pleased this issue may finally be close to resolutionin a way that will return fairness to the SBIR program.