FDA Unveils Transparency Initiative
The Food and Drug Administration recently announced the first phase of the Agency's 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
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
Democrats Mull Healthcare Options
As President Obama delivered his State of the Union address, Congressional Democrats continue to examine options on moving healthcare reform legislation forward. Democrats discussed the possibility of the House of Representatives passing the Senate bill passed in December. If the House voted affirmatively on the Senate bill, then the legislation would then go to the President for his approval. However, many in the House have already discounted this proposal, signaling that the health reform debate will remain in limbo.
Policy experts have also suggested that a scaled-back health reform bill may be included with an extension of the Medicare payment program for physicians, which is set to expire at the end of February.
The future of health care reform legislation remains unclear. However, MDMA will closely monitor the process and continue to fight for minimal impact on innovation and patient access of medical technologies.
For more information, please contact:
Erin Jones
Director, Membership and Programs
1350 I Street, NW
Washington, DC 20005
http://www.medicaldevices.org/
P: (202) 354-7172
F: (202) 354-7176 |