BioOhio Government Affairs Update
written and monitored by Colby & Company

Despite the negative economic forecasts, 2008 holds great promise for the growth and development of Ohio’s bioscience industry. Governor Strickland used his second State of the State speech last Wednesday to propose a $1.7 billion economic stimulus bond package — "Building Ohio Jobs" — that he projected would create more than 80,000 jobs. The growing biomedical industry receives significant attention in this stimulus package. BioOhio is engaged with the administration and Ohio Department of Development as an advisor (see full story above).

Legislative Issues  
Last October, BioOhio President Tony Dennis testified in support of SB 186, the Cancer Trials bill. He stated, “Biotechnology has already created more than 200 new therapies and vaccines, including products to treat cancer. There are more than 400 biotech drug products and vaccines currently in clinical trials targeting more than 200 diseases, with the majority targeted at various cancers. This bill will accelerate the continued drive to cure cancer by encouraging the wider application of cutting edge therapies.”

BioOhio continues to monitor health-related legislation that could affect the bioscience industry. HB 99 regulates the substitution of drugs intended to treat epilepsy. This bill would benefit brand name manufacturers by allowing doctors to require the prescription be filled “as written” rather than permitting a generic substitute. HB 137 requires certain health care policies, contracts, agreements, and plans to provide benefits for equipment, supplies, and medication for the diagnosis, treatment and management of diabetes and for self-management education. SB 278 requires certain health care policies, contracts, agreements and plans, as well as the state's Medicaid program, to provide benefits for colorectal examinations and lab tests.

Patent Reform
The Patent Reform Act of 2007 (H.R.1908/S.1145), introduced by Rep. Howard Berman (D-CA) in the House and Senator Pat Leahy (D-VT) in the Senate was passed out of the House of Representatives in September. The Senate is currently working on the legislation and many believe it will come to the Senate floor as early as mid-February. Of major concern to the bioscience industry are provisions relating to apportionment of damages, the creation of an unlimited second window, and the need for "inequitable conduct" reform. 

BioOhio offered members the opportunity to sign-on to an advocacy letter expressing these concerns. Eighteen members signed the letter, which was faxed to Senators Brown and Voinovich on February 12.

Follow-on Biologics
The Senate Health, Education, Labor and Pensions Committee passed follow-on biologics legislation last July. There have been several bills introduced in the House, including a proposal from Rep. Jay Inslee (D-WA) that is favorable to the industry because, among other things, it provides 14 years of data exclusivity. Additional proposals include a bill introduced by Congressman Henry Waxman (D-CA) that lacks safeguards for patient safety as well as protection for data exclusivity. The biotechnology industry is supportive of finding a pathway for the creation of follow-on biologics this year.

SBIR
The Small Business Innovative Research Program is up for reauthorization this year. Currently, companies that are more than 50% backed by venture capital are not eligible for SBIR dollars. This month the House Small Business Committee met to discuss ways to restore funding available for research focused on innovative new treatments for life-threatening illnesses. BIO and its state affiliates like BioOhio are hopeful that the need to reauthorize the SBIR program this year will serve as a vehicle to change eligibility standards for majority venture-backed bioscience companies.

BIO Legislative Day Fly-in
BIO’s 2008 Legislative Fly-in is on April 15-16, in Washington, D.C. The annual BIO Fly-in takes place every spring and hundreds of biotech industry executives participate. This event will provide an opportunity for the biotechnology industry to meet with the members of the 110th Congress and to advocate the BIO legislative agenda. BIO has several room blocks at several D.C. hotels, available until mid-March. To register or for additional information: www.bio.org/flyin.