510K Reform- FDA Preliminary Reports and Recommendations
Over the past several years, concerns have been raised about whether the 510(k) program optimally achieves its intended goals. CDRH, as well as the FDA, are considering specific areas of improvement for its 510(k) process for medical device companies.
The FDA released its preliminary recommendations from two comprehensive assessments on the 510(k) premarket review process and the use of science in CDRH’s regulatory decision making. To view the reports please visit: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm.
BIOCOM will soon be convening open meetings with our members so that BIOCOM can respond to the proposal in a way which best represents the concerns and insight of our medical device industry members. If you are interested in participating, please contact Madeleine Baudoin, Associate Director of Public Policy, at mbaudoin@biocom.org.
BIOCOM Elected Officials and Candidates Reception
On Thursday, August 12, the Amylin reflecting pool was the backdrop for the BIOCOM Elected Officials and Candidates Reception. Over 100 industry professionals, elected officials and candidates had the opportunity to chat in a casual, informal setting. Among the elected officials in attendance: Congressman Brian Bilbray, Assembly members Marty Block and Lori Saldaña, Supervisors Greg Cox and Ron Roberts, San Diego City Councilmember Sherri Lightner, Oceanside City Councilmember Jerry Kern. In addition, we had many candidates join us, including some who are likely to win election in November. This event is a unique opportunity to educate our elected officials and candidates about our industry and the challenges it faces.
Our sincere thanks to Genentech for again being the signature sponsor for this event.
More than 100 life science industry professionals, candidates for public office and elected officials and their staffs enjoyed BIOCOM’s PAC Reception around the reflecting pool at Amylin Pharmaceuticals.
R to L BIOCOM CEO Joe Panetta, Larry Stambaugh, Congressman Brian Bilbray, and Arena Pharmaceuticals CEO Jack Lief
On and On
As the California Legislature winds through the final days of its two-year session, there is not only an absence of a state budget, many observers also see little indication to believe one is imminent. The Governor is rumored to be proposing a loan from the state retirement system, while the budget proposed by the Assembly Speaker and Senate President Pro-Tempore relies on borrowing from the state Beverage Recycling Fund. The legislature’s Republican caucuses have been supportive of the Governor’s May budget proposal.
For up to date information on the state budget, the Sacramento Bee has a section devoted to the most current news regarding the ongoing negotiations.
The state constitution dictates that the Legislature will adjourn at midnight, September 1st in an election year (such as 2010). Although a special session on the budget is almost inevitable, most legislation will have a final disposition by September 1st. All bills that were priorities for opposition by BIOCOM this year have been defeated or withdrawn from consideration, but this is the time of year when bills mysteriously and magically “rise from the dead.” BIOCOM staff and our contract lobbyist in Sacramento will be watching diligently to insure the industry’s interests are protected. A list of the legislation BIOCOM is following can be found here
House Labor-HHS Appropriations Subcommittee Approves FY 2011 Spending; Recommends Funding the Cures Acceleration Network
On Thursday, July 15, the House Labor-HHS Appropriations Subcommittee approved their draft spending bill for fiscal year (FY) 2011 Labor-Health and Human Services-Education Appropriations bill by a vote of 11-5.
Although the draft bill and committee report have not yet been made public, the Subcommittee did post a list of earmarks and a summary table online. This includes just over $32 billion for NIH, an amount equal to the President's request, and approximately $1 billion (3.2 percent) over the final FY 2010 funding levels. The appropriations also include $50 million for the Cures Acceleration Network Program (CAN) which was approved as part of the health care reform legislation that President Obama signed into law on March 23, 2010. The newly approved Cures Acceleration Network seeks to cut the time between discovery and development of new drugs, biologics, and devices to treat and cure high need diseases through new grant making mechanisms at NIH. This includes establishing CAN within the Office of the Director of NIH, developing a CAN Board that would analyze the research needs and establish and authorize grants expected to move discoveries from the lab into the next generation of therapies. Unfortunately, $50 million is only 1/10 of the amount the NIH requested to be appropriated for CAN, and 1/10 of the recommended $500 million in section 402C(g)(1) of the CAN Act.
It’s unlikely our congressional leaders will be able to move forward the final Appropriations bill before the October 1 deadline, so they will most likely move forward a continuing resolution of the FY 2010 funding levels this fall.
As BIOCOM continues its advocacy efforts on Capitol Hill during the FY 2011 budget debate, we encourage all BIOCOM members to join us in supporting increased funding for NIH, including $500 million for CAN in the final fiscal year (FY) 2011 Appropriations bill. Here is a link to BIOCOM’s letter of support for increased funding for NIH. We encourage you to reach out to your representatives, our senators and representatives need to hear from BIOCOM members about ensuring adequate NIH funding in FY 2011.
SOX Relief for Small Emerging Public Companies Clears Senate
The Dodd-Frank Wall Street Reform and Consumer Protection Act, which was approved by the House on June 30, before clearing the Senate by a vote of 60-39 on July 15, was signed into law on July 20, 2010. The new law includes an important provision BIOCOM supported that exempts smaller companies with market capitalizations of $75 million or less from complying with the regulatory burdens of Section 404(b) of the Sarbanes-Oxley Act of 2002 (“SOX”). The act also requires the SEC to complete a study within nine months of the act’s enactment on how to reduce the burden of 404(b) compliance for companies with market caps between $75 million and $250 million. Here is a copy of BIOCOM’s letter of support for a permanent exemption from Section 404(b) of the Sarbanes-Oxley Act of 2002.
Director of CDRH Hosting Town Hall Discussion in Irvine on October 7
The FDA Center for Devices and Radiological Health (CDRH) will be hosting its third and last town hall meeting on Oct. 7, at the Hilton Irvine at 18800 MacArthur Blvd., Irvine. At the meeting Dr. Jeffrey Shuren, the Director of CDRH, is expected to present the FY 2010 CDRH priorities. Next, industry representatives and other public citizens will be given the opportunity to present comments and feedback to CDRH. In addition, the attendees from CDRH will respond to questions presented by industry and other public citizens. Meeting details and registration info can be found here. Online registration is available until September 22, 2010. http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm215113.htm
Expiring R&D Tax Credit Most Likely to be Dealt with After November Election
Last month the Senate came up three votes short of the 60 needed to extend the expiring Research and Development tax provisions that were originally part of H.R. 4213, the American Jobs and Closing Tax Loopholes Act of 2010. Most observers believe a final bill containing the R&D credit may have to wait until a “lame-duck” session of Congress. As BIOCOM continues its advocacy efforts on Capitol Hill, we encourage all BIOCOM members to continue voicing support for the extension of the research and development tax credit, which is perhaps the single most important tax credit to our industry as a whole.