Legislative Session Ends in Flurry for
Life Sciences Industry

The end of September was the deadline for Governor Arnold Schwarzenegger to sign or veto all bills the legislature passed this year. With the Governor’s decisions on these final bills, the 2008 regular legislative session has closed. In addition to its work on tax policy, BayBio also took positions on several bills important to the success of the life sciences industry. The final days of the legislative session resulted in final decisions on several pieces of legislation important to the industry this year.

Fire Codes Authority
The Governor signed Senate Bill 1668 (Migden) into law. SB 1668 clarifies the authority of the State Fire Marshal to allow for the development of the L-Occupancy code. BayBio worked with a coalition of companies and industry organizations from California to encourage state regulators to approve changes to California’s building and fire codes to support the growth of new life sciences facilities. The passage of SB 1668 clarifies existing law and allows the Office of the State Fire Marshall to proceed with publication and distribution of the new L-Occupancy regulations.

Complying with the PhRMA – Five Simple Steps
By Bill Braddock

The recently released PhRMA Code scheduled to take effect January 1, 2009, is an extension and amplification of the Code that became effective July 1, 2002. The Codes are remarkably similar, and focus on perceived abuses of pharmaceutical industry interactions with healthcare professionals (HCPs).

There is a clear distinction between legitimate pharmaceutical promotion and possible inappropriate interactions with HCPs. Traditional product promotion is not addressed in either of the Codes, but gifts from pharmaceutical manufacturers, their representatives, and other manufacturer interactions with HCPs are covered in detail. While final decisions regarding compliance will be made by each company’s Regulatory and Legal Departments, it will be helpful to keep these simple tips in mind when marketing your treatments and products.

Tax Changes to Benefit Life Sciences Companies

In recent weeks and months, there have been many newsworthy legislative events affecting both the life sciences industry and the business community at large. Within that list are two significant national and state provisions that directly impact growing life sciences companies and which merit special discussion. To ensure that the life sciences companies in Northern California are aware of how they can potentially take advantage of these provisions, BayBio is holding a series of seminars on October 27 and 28, presented by local accounting firms, with tax implementation experts as well as briefings by policy directors from BayBio and BIO (Biotechnology Industry Organization).

MDMA's Washington Update

Senate Committee Examines Medical Device Advertising

The Senate Select Committee on Aging held a hearing in September to examine the Food and Drug Administration’s policy on direct-to-consumer (DTC) advertising of medical devices. The panel heard testimony from government, industry, academic and other stakeholders. MDMA has been working with the Committee to highlight the benefits that may result from this form of marketing, including patients being proactive about their health care needs.

More information on the hearing can be found on the Committee’s website:
http://aging.senate.gov/hearing_detail.cfm?id=303085&

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The Golden State stands at an economic crossroads. As lawmakers in Sacramento struggle to address a problematic budget in the face of economic crisis and maintain critical state services, they run the risk of overlooking a bright spot in our economy. California’s life sciences industry offers a potential boon for the economic future of the state, but requires careful stewardship and stable policy to advance the treatment pipeline—turning innovation into cures for patients.

Over the next three to five years, California-based life sciences companies will invest close to $50 billion to research, develop and manufacture 230 treatments and products. This massive investment will fund the construction of new facilities, the purchase of new equipment and other capital goods, and the addition of new employees to the workforce. These companies are mostly small businesses ranging from five to 100 employees and benefit their local communities while they work to cure cancer, diabetes, HIV and other medical diseases and conditions. In aggregate, these companies create 12,000 new jobs each year that pay an average salary of nearly $70,000.