$975 Million in Government Grants to Expand the Use of Health IT
On February 12th, President Obama announced $975 million in government grants to expand the use of health IT through 2014. $225 million of this funding will be available through the Department of Labor to train 15,000 people in job skills needed to support careers in health IT and $750 million will be available through HHS for states, hospitals and medical professionals.
2010 California Biomedical Industry Report
PricewaterhouseCoopers LLP and CHI have released the 2010 California Biomedical Industry Survey Report. Here is a link to the Report: http://www.chi.org/basicpage.aspx?id=6704
Billy Tauzin to Step Down in June as Head of PhRMA
Billy Tauzin, President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) announced his retirement, effective June 30. Mr. Tauzin will continue to serve the organization in a consultancy role after that date. Most recently, Tauzin negotiated an agreement with the White House for the industry to contribute approximately $80 billion within the Administration’s health care reform package.
It’s Coming! Sign Up for Construction Alerts Before Terminal 2 Construction Starts in March
Get ready for an improved airport! Beginning in March, travelers to/from San Diego International Airport will notice construction activity in front of Terminal 2 related to The Green Build, the largest project in the airport’s history.
To accommodate construction activity on the dual-level roadway at Terminal 2, some parking will be temporarily relocated and the pedestrian bridges will be removed. Frequent shuttles will transport travelers from relocated parking areas to the terminals.
The Airport Authority has set up several ways to receive timely information about activity that could potentially impact travel time to the airport. To receive e-mail alerts, please complete the online form. Or, you can follow the airport on Twitter (@SanDiegoAirport) or become a Facebook fan.
The Authority wants to be sure that all travelers are informed about this activity. Please forward this e-mail to your staff, friends and family who may be interested in signing up for these updates.
The Green Build will bring a number of long-awaited upgrades for passengers traveling in and out of San Diego International Airport. All travelers – whether visiting San Diego County on vacation, traveling on business or headed out of town on holiday – will reap the benefits of these improvements. Travelers can expect to take advantage of the finished facilities in 2013.
You can find additional information about The Green Build at www.san.org, or call the construction hotline at (619) 400-2288 and someone will respond within one business day.
The Green Build Highlights:
- 10 new jet gates at Terminal 2
- A dual-level roadway at Terminal 2
- New, expanded dining and shopping options
- More comfortable waiting areas at the gates
- Increased number of security lanes
- Additional aircraft parking
Legislature Poised to Make Budget Cuts
As reported in the last Biocommunique, in January Governor Arnold Schwarzenegger released his proposed budget for the 2010-2011 fiscal year. This budget seeks to address a projected $20 billion shortfall in revenues, and although the Governor’s budget may not resemble whatever is ultimately signed, the state budget will almost undoubtedly impact the life science industry.
The Legislature appears to be preparing this week to cast votes on how to close some of this shortfall, and an issue of critical importance to the life science industry has become a key point of contention. The Sacramento Bee, reports that the Governor is balking on a key component to the Democrats’ plan, a reduction in the percentage of net operating losses (NOL’s) companies can use to offset current year tax liabilities to 68 percent for tax year 2010. NOL’s are particularly important to companies just entering profitability, as life science companies incur large operating losses for many years before they become profitable.
The Democratic proposal seeks to change a key element of the February, 2009, budget compromise in which utilization of NOL’s was suspended for two years in return for conformity to the federal standard of 20 years in which to employ them (up from 10 years). It remains unclear whether the Democrats will head back to the negotiating table with the Governor or pass the measure as currently constructed.
Please keep an eye on the BCQ to keep current on the state budget as it progresses through the process.
Congress Approves Temporary Extension of SBIR Program
The House of Representatives and Senate have both passed legislation that would temporarily extend the Small Business Innovation and Research program through April 30, 2010. Both the House and Senate passed the extension by an overwhelming majority. Congress has attempted to reauthorize the program for several years. However, fundamental policy differences have led to temporarily reauthorizations to continue funding the programs.
In 2003, the Small Business Administration implemented a rule change which restricted eligibility to non-venture capital majority owned firms. Since that time, the number of innovative medical technology companies applying for grants has significantly decreased. MDMA has advocated for a repeal of this rule so that medical device companies with majority venture-ownership to once again compete for SBIR grants.
http://www.prnewswire.com/news-releases/senate-approves-extension-of-sba-programs-82990762.html
FDA Unveils Transparency Initiative
The Food and Drug Administration recently announced the first phase of its transparency initiative. The goal of the initiative is to provide the public a better understanding of the agency’s decision making process and operations. FDA leadership has stated that it intends to make the agency more user-friendly to the public.
In 2009, as part of the initiative, MDMA submitted comments to the Transparency Task Force. MDMA used the opportunity to highlight some of the transparency issues associated with the panel process for device reviews. Specifically, MDMA recommended that the agency restructure the panel process to increase transparency by requiring anonymous and simultaneous voting on approvals, requiring panelists to certify they have read panel materials, focusing only on questions and issues germane to the review of the product, and several other key recommendations.
The FDA will be holding two public hearings regarding the medical device approval processes on February 9 and February 18
Information on the February 9 meeting can be found here:
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm191579.htm
Information on the February 18 meeting can be found here:
http://edocket.access.gpo.gov/2010/2010-1620.htm
Health Care Reform Summit to be Televised- February 25 at 7 a.m. Pacific
On February 12th, President Obama announced a bipartisan Health Care Reform Summit to be held on February 25. Invited were the chairs and ranking members of five committees of jurisdiction in the House and Senate, as well as representatives from the Congressional Budget Office, Joint Committee on Taxation, White House Office of Health Reform, and eight additional members of Congress designated by party leadership. This meeting will be a televised bipartisan meeting at the Blair House beginning at 7 a.m. PT on February 25 to discuss health reform legislation.
The President is expected to offer opening remarks at the beginning of the meeting, followed by remarks from a Republican leader chosen by the Republican leadership and a Democratic leader chosen by the Democratic leadership. The President will then open and moderate discussion on four critical topics: insurance reforms, cost containment, expanding coverage, and the impact health reform legislation will have on deficit reduction.
The White House released its Health Care Reform proposal on February 22nd which can be found here: http://www.whitehouse.gov/health-care-meeting/proposal. The proposal keeps intact many features found in the December 24, 2009 approved Senate bill, with the exception of the public option and employer mandate.
Although the President has publicly lobbied to reduce the 12 year period of data exclusivity for biosimilars passed by both houses of Congress to 7 years, there is no mention of a specific data exclusivity period for biosimiliars in the President’s proposal.
As Congressional leaders weigh various options, some public policy experts are suggesting the House may consider moving forward bits and pieces of the Senate approved health care reform bill as soon as this April. This would be done by passing a series of amendments from the Senate bill that could be considered in reconciliation, which means 50 votes to pass, virtually guaranteeing that Republicans could not successfully filibuster.
Relationship Survey: Gauging the Health of Your Relationship with the FDA
In an ideal world, everyone would have a strong and positive relationship with the FDA. With that as a goal, PricewaterhouseCoopers LLP and BIOCOM have launched their fifth survey –Improving America’s Health V Survey – to gauge the working relationship between the life sciences industry and the FDA. Your feedback is important to make this survey a success. To participate, please send an email to PricewaterhouseCoopers.and.BIOCOM@us.pwc.com with “Life Sciences FDA Survey” in the subject line. A survey will then be forwarded to you. The survey should take only 15 to 20 minutes to complete. All responses to the survey will be kept confidential and private.
Those who participate in the survey will receive a preview copy of the results prior to their public release. The survey will close on Feb. 26. Please help foster improved relations between our industry and the FDA. A copy of the last survey report can be accessed here.