FDA’s 2011 Plan -- Medical Device 510(K) Approval Process
Last week the FDA announced its 25-step plan of action which outlines the 510(k) approval process recommendations they plan to implement in 2011, as well as their projected timeline for completion.
The plan includes some key actions that have potential to address inefficiencies and improve predictability and timeliness of the 510(k) review process. This includes their plan to involve scientific experts, streamline and reform the “De Novo” process, and enhance training for center staff.
The implementation plan gives no feedback on the most controversial CDRH working group recommendations which most significantly concerned BIOCOM, but rather requests that the Institute of Medicine (IOM) provide feedback on these issues. These concerns include the working groups recommendations focused on off label use, the addition of a new class IIb device category, and its proposal to give the agency rescission authority over 510(k) clearance.
Sources indicate that the new plan of action will be rolled out in increments through a process of guidance documents and proposals that will be open for public comment. BIOCOM will continue to monitor the process and work to comment on any draft documents and proposals which best represent the concerns and insights of our medical device industry members.
Water Rate Increases Again
On Monday, January 24, 2011, the San Diego City Council voted 6-2 to raise average water rates approximately 6.4% in response to rate increases from its wholesaler providers, the San Diego County Water Authority (SDCWA) and the Metropolitan Water District (MWD). It was argued that if this rate “pass through” was not approved, it could have created a structural deficit in the City’s aging water and sewer infrastructure.
On April 13, 2010, the MWD Board of Directors approved 7.5% rate increases for calendar years 2011 and 2012. The San Diego City Council’s rate increase was in response to the 2010 MWD increase and the corresponding increase by the SDCWA. As a MWD rate increase is already scheduled for 2012, another “pass-through” rate increase can be expected to be proposed in the City of San Diego for calendar year 2012 following the next CWA adopted increase.
On June 10, 2010 the SDCWA filed a lawsuit challenging the MWD’s water rates for 2011 and 2012. Public agency finance experts and legal experts retained by the SDCWA assert that MWD is not following the law because it is misallocating funds in supply cost from its supply rates to its transportation rates. THE SDCWA believes this is illegal because it forces the SDCWA and its ratepayers to pay more than MWD’s actual costs for transporting Colorado River water to the San Diego region. By disguising the true cost of imported water, MWD’s rate structure discourages local water agencies from investing in new water supply projects because those projects appear to be more expensive than buying imported water from MWD. Unfortunately, until this matter is resolved it is likely that the price of water will continue to go up for rate payers.
Mike Lee of The San Diego Union-Tribune did an outstanding background piece on the rate increase over the weekend. For more information please contact Faith Picking, Public Policy Manager at fpicking@biocom.org.
BIO Therapeutic Tax Credit Survey
The Biotechnology Industry Organization (BIO) is conducting a survey to evaluate the industry’s company-by-company experience with the Qualified Therapeutic Discovery Project (QTDP) program. As an organization which strongly supported the enactment of the Qualified Therapeutic Discovery Project (QTDP), BIOCOM is asking members who qualified for the credits and grants to participate in the survey.
The survey is designed to ask a series of questions about each project your company submitted an application for, not to exceed 4 total projects. Please have your company’s application(s) on hand (IRS Form 8942) to help you complete the survey more quickly. The survey will take 10-15 minutes. This information will be invaluable as BIO and BIOCOM seek similar incentive programs in the future.
Plesae provide your contact information here. Upon verifying your contact information, you will be invited to participate in the survey.
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