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.
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.
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