California's State Budget
As you probably have heard, the Legislature and Governor have passed a $40 billion plan to address California’s budget deficit for 2009 and 2010. This plan includes spending cuts, tax increases, borrowing and federal economic stimulus monies.
Highlights of the budget increases are a 0.25% rise in personal income tax (which could be reduced to 0.125% if the state reaches a specified trigger in federal stimulus monies), a 1 cent temporary sales tax increase, an increase in the Vehicle License Fee, and a reduction of the dependent care credit.
A summary of the budget package has been prepared by BIOCOM’s contract lobbyist in Sacramento, the firm of Sloat, Higgins, Jensen and Associates, and can be found here.
Get Involved in Public Policy
Now that most people are over New Year’s resolutions, we’d like to propose a new one—get more involved in the policy decisions that shape our industry. It’s very simple, will only take a day of your time, and someone else will do a lot of the work for you.
On Tuesday, March 24th, industry professionals and patient advocates will converge on Sacramento to provide a human face to the industry detailing the challenges we face every day. Meetings are pre-scheduled for you, and participants are broken up into groups to go to meet with legislators and their staffs. These are the people who have the power to make the laws that affect our industry and whether the industry continues to grow in California. Your stories do make a difference. The day is capped by a reception attended by the participants and many legislators, where you can speak to them in a much more informal setting.
Life Sciences Day is a joint effort of BIOCOM, BayBio, the California Healthcare Institute, and the Southern California Biomedical Council.
To register for California Life Sciences Day, please go to http://www.lifesciencesday.org/ (Jimmy Jackson).
Water, Water Everywhere and Not Enough to Drink
As many of you are well aware of our region is facing a serious water crisis. Water reliability continues to be an important priority for BIOCOM. The life science industry has historically been a long time advocate of water conservation. We encourage you to review the City’s Water Emergency website to learn more about the crisis: http://www.sandiego.gov/water/conservation/drought/
Many of our members have already done their part by voluntarily implementing water conservations measures within their own company. The City of San Diego anticipates that mandatory water cutbacks will begin this summer; indeed, this is not unique to the City of San Diego, many if not all water districts in the County of San Diego will enact some form of water rationing this year.
We recognize our industry has been a leader in responsible water management, which may make it more difficult for some of our members to make additional cutbacks. BIOCOM has been working with industry stakeholders and the City to protect our members by advocating for a fair water allocation methodology which factors in the amount of water needed for basic operation of a life science company. It is our hope that if we can develop such a methodology with the City of San Diego, other water providers throughout Southern California can be convinced to adopt similar standards.
In order to further assess and address industry concerns, BIOCOM is hosting a Water Workshop. This is your time to come and share your insight with the City of San Diego staff on how the allocations will affect your company. For more information or to register please click here: http://biocom.org/event/water/ (Faith Picking).
Medical Device News from MDMA
Grassley, Kohl Release Revised Transparency Legislation
Senator Chuck Grassley, Ranking Member of the US Committee on Finance, and Senator Herb Kohl, Chairman of the Senate Committee on Aging, released a revised draft of legislation to bring transparency to physician-manufacturer relationships. Specifically, the most recent version of the Physician Payment Sunshine Act would require manufacturers to report payments to physicians that exceed $100 annually, including gifts, meals, or other transfers of value. The proposal also includes a Federal preemption provision to trump certain state reporting requirements. However, a newly added provision expands the capability of state laws to require additional disclosures outside of the proposed Federal law.
FDA Scientists Ask New Administration to Reform Agency
An anonymous group of scientists at the Food and Drug Administration formally contacted the Obama Administration to voice their concern on what they perceive to be inadequacies at the Agency. According to the letter, the main concern is the Agency’s scientific review process for medical devices, which they believe has been corrupted by several senior FDA officials. While mentioning broad problems, published reports did not cite any specific cases of malfeasance.
A similar letter was sent to Congressman John Dingell, Chairman of the House Energy and Commerce Committee, last year.
GAO Releases Report Validating Current 510(k) Review Process
The Government Accountability Office (GAO) recently published a report on FDA’s 510(k) review process. The report validates the current 510(k) review process. However, the GAO recommended that FDA review the small number of Class III products currently using the 510(k) premarket review pathway and either reclassify the products or require them to be reviewed via the PMA process. MDMA agrees that this is the appropriate approach versus modifying the underlying 510(k) process.
http://www.gao.gov/new.items/d09190.pdf
http://www.gao.gov/new.items/d09190.pdf
IP Management in Tough Economic Times: Cost Effective Strategies
In this difficult economy, many companies are being forced to cut back on staff, research activities, and sometimes even new product development. Yet to come out of this depressed cycle, we need to take steps to protect the intellectual property that will support our products. To assist you, the BIOCOM IP Committee will be presenting a workshop on March 12 entitled “IP Management in Tough Economic Times.” An expert panel will present useful guidance and practical tips on:
Curating your portfolio to better align it with your business strategy: trigger points for portfolio reviews; abandoning IP from abandoned projects; focusing IP for active projects; packaging your IP for mergers and acquisition
Cost-effective planning for global protection: determining where to file and market share; costs; valuation of partnering; strategic use of data exclusivity
Adapting to changing IP laws: new case law; legislative reform; new rules; IP protection for new technologies
Repurposing your IP for maximum value: business model; expansion of IP coverage
Preparation for IP enforcement actions: preparing for enforcement; alternatives to litigation; opinion letters; patent reexamination.
Following the presentations, the experts will be available to answer your questions in a moderated panel discussion.
To register for this important and timely workshop, click here. You expect your company to survive this economic downturn. Be sure your IP survives as well.
Submitted by BIOCOM's Intellectual Property Committee Co-chairs Bernie Greenspan and Les Overman.
Please send your comments or suggestions to BiocomIP@gmail.com.