On behalf of our membership and California’s statewide life sciences community – a sector which employs over 311,000 Californians – California Life Sciences Association (CLSA) welcomes Congressman Harley Rouda (D-Laguna Beach). We look forward to working with Rep. Rouda and his team to advance policies that improve patient health and bring positive change for California patients and their families.
In November 2018, the Trump Administration proposed a rule that would weaken patient protections within Medicare’s Part D prescription drug benefit. Currently, Medicare Part D drug plans are required to comply with the “protected drug classes” policy, which ensure that beneficiaries have access to “all or substantially all” drugs in six specific classes of medicines (like antiretrovirals, antidepressants, antipsychotics, and anticonvulsant agents).
In the coming weeks, legislation will be introduced to permanently repeal the medical device excise tax.
On Feb. 7, the CLSA’s federal government relations team hosted 10 members of CLSA’s board of directors and President & CEO, Mike Guerra, for a full day on Capitol Hill meeting with 9 members of the California delegation.
By Jenny Nieto Feb. 20, 2019 As you may know, last October, the Administration released an Advanced Notice of Proposed Rulemaking (ANPRM) to lower Medicare Part B costs and list prices over 5 years by setting certain Part B drug prices based on an “International Pricing Index” (IPI), against which US prices will be assessed. CLSA … Continue reading CLSA Expresses Deep Concerns and Opposition to Administration’s International Pricing Index (IPI) Proposal
On behalf of our membership and California’s statewide life sciences community – a sector which employs over 311,000 Californians – California Life Sciences Association (CLSA) welcomes Congressman TJ Cox (D–San Joaquin Valley). We look forward to working with Rep. Cox and his team to advance policies that improve patient health and bring positive change for California patients and their families.
On Jan. 25, 2019, the longest partial government shutdown in history came to an end, when President Trump announced he and bipartisan congressional leaders had reached an agreement to temporarily fund and re-open the federal government through mid-February while they continue working out a larger immigration and border security compromise.
As the federal government shutdown stretches past one month, CLSA continues to monitor the situation, including the operations of agencies critical for life sciences innovation.
With the opening of the 116th Congress, California’s congressional delegation in the House of Representatives continues to rank amongst the most influential, with numerous members serving in positions of leadership and on committees with jurisdiction over issues and policies critical to the continued advancement of our state’s and the nation’s life sciences sector. Notably, California’s 46 Democratic members comprise 20% of all House Democrats – the current majority party.
On behalf of our membership and California’s statewide life sciences community – a sector which employs over 311,000 Californians – California Life Sciences Association (CLSA) welcomes Congressman Gil Cisneros (D–Yorba Linda). We look forward to working with Rep. Cisneros and his team to advance policies that improve patient health and bring positive change for California patients and their families.
In October, the Administration unveiled a plan with the intention to lower Medicare Part B costs and medication list prices over 5 years. Specifically, the proposal will set certain Part B drug prices based on an “International Pricing Index” (IPI).
The House of Representatives is expected to vote this month on a tax extenders package that, among other things, includes a 5-year suspension of the medical device excise tax.
By Jenny Nieto Nov. 16, 2018 On Nov. 16, CLSA was honored to convene a Meet & Greet with Representative-elect Mike Levin (D-San Juan Capistrano/San Diego) at our Washington, DC office. As you may know, attorney Mike Levin was elected Nov. 6 to serve as the new U.S. Representative for California’s 49th Congressional District. He … Continue reading CLSA Hosts Meet & Greet with Congressman-elect Mike Levin (CA-49)
CLSA’s federal government relations team is pleased to provide you with this update on the 2018 Midterm Elections, including the likely makeup of our incoming California delegation for the 116th Congress, and additional details on several key California congressional races you may be interested in.
Addressing drug pricing and improving healthcare access and affordability remains a salient topic on Capitol Hill, in the Trump Administration, with industry and the public. Over the summer, the Administration released its American Patients First blueprint, and over the past several weeks, the Administration has announced draft or final proposals intended to lower drug prices and increase access to affordable prescription drugs.
Both the House and Senate have adjourned until after the midterm elections. While the outcome of the elections will determine whether the Democrats win a majority in either the House or the Senate (or both), or if the Republicans maintain control of one or both chambers in the 116th Congress, both the House and Senate will return to Washington, D.C. in late November and early December (approximately 16-20 legislative days) to finish legislative work prior to the end of the year and the 115th Congress.
CLSA was a proud sponsor and participant of the 6th Annual Rally for Medical Research & National Day of Action on Sept. 13-14, 2018, an annual event that brings together more than 300 organizations to call on our nation’s policymakers to make funding for National Institutes of Health (NIH) a national priority.
On Sept. 11, CLSA co-hosted a multi-state life sciences association Congressional briefing on the patent system and how it works toward encouraging innovation in the development of life saving technologies.
CLSA’s federal government relations team provides an update on the outlook for key federal life sciences legislation likely to be addressed this year in Congress.
This August, CLSA participated in a medical technology industry roundtable discussion with Congressman Khanna (D-Fremont). Organized by AdvaMed and hosted by BD Biosciences in San Jose, attendees included representatives from CLSA members BD and Roche, and other medtech innovators including Boston Scientific, Elekta, Stryker and Varian.
In early August, CLSA organized a 2-day tour of multiple life sciences sector companies and research institutions across the Bay Area for Congressman Tony Cárdenas (D-San Fernando Valley), and his Washington DC-based staff. Cárdenas and our CLSA Federal Government Relations team visited & toured regional CLSA member companies including: Sutro Biopharma (San Carlos), 23andMe (Mountain View), Johnson & Johnson Innovation | JLABS (South San Francisco), and BioMarin (San Rafael and Novato).
Today, CLSA applauded the U.S. House passage of H.R. 184, the Protect Medical Innovation Act, which permanently repeals the job and innovation hindering 2.3% medical device excise tax levied on medical technology companies.
CLSA Board Member David Beier pens an op-ed in STAT News regarding the impact of the 2.3% medical device tax on patient care and innovation.
With the 2018 midterms elections only months away, the California Congressional delegation will soon be welcoming their newest members in the 116th Congress. Since the California Primary Elections in June, CLSA has held three meet and greets with Congressional Candidates: Diane Harkey, Mike Levin and Young Kim.
CLSA is proud to endorse the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5997), bipartisan legislation that bridges Medicare patient access gaps and modernizes policies to allow coverage of medical technologies approved through FDA’s expedited review process.
As results from yesterday’s California Primary Elections continue trickling in, the CLSA federal government relations team would like to share a brief update on some anticipated changes in the makeup of our California delegation for the 117th Congress, and offer additional details on several key California congressional races you may be interested in.
The FDA recently launched an “Innovation Challenge” intended to spur the development of medical devices to help combat the opioid crisis and achieve the goal of preventing and treating opioid use disorder.
Despite media and policymaker scrutiny over the cost of prescription drugs, the healthcare companies making the most money are not biopharmaceutical innovators. Check out CLSA’s infographic calling for more accountability of Pharmacy Benefit Managers (PBMs).
On May 23, 15 members of CLSA’s board of directors spent a full day on Capitol Hill meeting with 16 key Members of Congress on issues of importance to California’s biomedical innovation ecosystem.
CLSA is excited to launch a new video series to tell the stories of California patients whose lives have been positively impacted by the California life sciences sector.
After a productive day of meetings on May 23 with Members of Congress from the California congressional delegation on Capitol Hill, CLSA hosted our annual Spring Reception at the Folger Shakespeare Library, followed by a private dinner with our Board to recognize three Members of Congress – Ami Bera, M.D. (D-CA-7), Raul Ruiz, M.D. (D-CA-36) and Erik Paulsen (R-MN-3) – as bipartisan recipients of CLSA’s 2018 Visionary Awards for their leadership in promoting thoughtful public policies to advance biomedical research, investment and innovation.
Bipartisan Legislators Named 2018 Visionary Award Recipients for Promoting Policies that Advance Biomedical Innovation at CLSA’s Annual Washington, D.C. Program
On May 14, CLSA hosted a congressional briefing on America’s biodefense and emergency preparedness, with a focus on why reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) is critical for ensuring our nation’s biodefense and pandemic preparedness.
This month, CLSA’s Federal Government Relations team participated in the annual BIO Fly-In to advocate for biomedical innovation, investment, and job creation in California. CLSA took part in a total of 18 meetings with bipartisan members of the California Congressional Delegation.
CLSA is proud to endorse bipartisan, bicameral legislation to curb abusive patent litigation practices while maintaining and strengthening important patent-holder rights and protections.
As a result of CLSA’s advocacy efforts, 35 members of the California delegation signed on to a letter urging for an increase of at least $2.2 billion for the National Institutes of Health (NIH) as part of this year’s congressional appropriations process.
Last month, CLSA President & CEO, Sara Radcliffe, and our Federal Government Relations team participated in AdvaMed’s State MedTech Alliance (SMTA) annual fly-in to advocate for medical technology investment, innovation and jobs.
CLSA’s seasoned federal government relations team is engaged on behalf of the biomedical, agriculture, and industrial biotechnology sectors in multiple ways through strategic collaborations and direct lobbying in Washington, D.C. to advance innovation, investment and job creation for California’s treasured life sciences ecosystem. Read CLSA’s 2018 federal policy goals here.
This month (February 9), Congress passed and the President signed into law a full and permanent repeal of the Independent Payment Advisory Board (IPAB). Eliminating the IPAB is critical for the continued success of California’s innovative life sciences sector, because the board could have harmed biomedical innovation by reducing incentives for investment in new research and product development.
On Jan. 22, Congress passed a 2-year suspension of the medical device excise tax, retroactive to Dec. 31, 2017, providing much-needed relief for California’s medical device sector.
On Jan. 24, the United States Senate confirmed Alex Azar as the next secretary of the U.S. Department of Health and Human Services (HHS) by a vote of 55 to 43.
CLSA, the trade association representing California’s life sciences industry, today commended the U.S. Senate’s confirmation of Alex Azar as the new secretary of the U.S. Department of Health and Human Services (HHS).
InsideHealthPolicy features commentary from CLSA President & CEO Sara Radcliffe regarding the 2 year suspension of the medical device tax.
California Life Sciences Association (CLSA) applauds the House and Senate passage of legislation that temporarily suspends the ill-conceived 2.3% medical device tax for an additional 2 years, until December 2019.
On Dec. 20, Congress passed a sweeping overhaul of the tax code in the form of H.R. 1, the Tax Cuts and Jobs Act. While CLSA did not take a position on the overall legislation, we did work in close collaboration and coordination with BIO and our CLSA member companies to ensure that the Orphan Drug Tax Credit – a meaningful incentive for investment in rare disease therapy innovation – was preserved in the final bill passed by Congress.
This month, Reps. Erik Paulsen (R-Minn.) and Jackie Walorski (R-Ind.) and House Ways & Means Committee Chairman Brady (R-Texas) introduced new legislation to provide a 5-year suspension of the medical device excise tax (H.R. 4617). The current suspension of the 2.3% medical device excise tax expires Dec. 31, 2017.
Sara Radcliffe, Pres. & CEO, CLSA & Don Bobo, Corporate Vice President, Strategy & Corporate Development, Edwards Lifesciences, pen an op-ed in The O.C. Register, urging Congress repeal the 2.3% medical device tax. The tax stands to threaten an innovative medtech sector that employs over 22,000 in Orange County and 77,200 statewide.
On Dec. 6, CLSA hosted our annual End of Year Reception on Capitol Hill in Washington, DC. Over 150 guests attended the reception, including California Reps. Tony Cárdenas, Jimmy Panetta), Jackie Speier, and David Valadao, and staff from more than half of our California congressional delegation’s offices.
During Crohn’s and Colitis Awareness Week, CLSA hosted a congressional briefing on Dec. 6 on “Enhancing Patient Access to Therapies for Inflammatory Bowel Disease (IBD).”
California Life Sciences Association (CLSA) welcomes the introduction of H.R. 4617, legislation that places a 5-year freeze on the ill-conceived 2.3% medical device excise tax. Without swift enactment of this measure, the medical device tax would further hamper innovation and investment in medical technology research and development.
Congress is currently advancing legislation in both chambers to significantly overhaul the U.S. tax code. Historically, CLSA has focused our tax-related advocacy efforts around: (1) calling for an update and making permanent of the R&D Tax Credit, (2) protecting the Orphan Drug Tax Credit (ODTC), and (3) opposing the creation of and later calling for a repeal of the medical device tax.
The Independent Payment Advisory Board (IPAB) is a controversial advisory board enacted as part of the Affordable Care Act in 2010, which threatens seniors’ care and could harm biomedical innovation by reducing incentives for investment in new research and product development.
For over 7 years, CLSA has advocacted for repeal of IPAB because such blunt cost containment approaches could seriously harm the delicate cycle of biomedical innovation by reducing incentives for investment in new research and product development, and ultimately limit patient access to lifesaving treatments, therapies and technologies.
On August 25, the Centers of Medicare and Medicaid Services (CMS) officially withdrew the proposed Center for Medicare & Medicaid Innovation (CMMI) Part B Demonstration, the “Medicare Part B Drug Payment Model” (CMS-1670-F).
On Oct. 12, the National Institutes of Health (NIH) announced a new partnership with 11 biopharmaceutical companies aimed at accelerating innovation in new cancer immunotherapy therapies. Nine of the 11 companies are CLSA members: AbbVie; Amgen; Boehringer Ingelheim Pharma GmbH & Co. KG; Bristol-Myers Squibb; Celgene Corporation; Genentech, a member of the Roche Group; Gilead Sciences; Janssen Pharmaceutical Companies of Johnson & Johnson; and Pfizer, Inc.
CLSA was greatly honored to welcome Dr. Robert Califf as the keynote speaker at our recent Evening with Thought Leaders in Los Angeles. Dr. Califf has had an extraordinarily impressive career as a cardiologist, Commissioner of the Food & Drug Administration (FDA), and now as a researcher with Duke University and advisor at Verily, an Alphabet company.
This September, CLSA participated in the 4th Annual Rally for Medical Research Hill Day to support funding for the NIH, and to continue efforts to make funding biomedical research a national priority.
CLSA hosts Congressman Tony Cárdenas (D-San Fernando Valley) for 3-days of tours at multiple life sciences sector companies and research institutions across the San Diego region.
With the first three-quarters of the year behind us, the remainder of 2017 will focus on raising the debt ceiling, preventing a government shutdown, and another top priority for the Trump Administration, tax reform.
U.S. Senate Approves Measure to Support Operations at the FDA to Help Propel Bioscience & MedTech Investment and Innovation
Update on Key CLSA Federal Policy Activities in Washington, D.C.
On July 13, Medicare Trustees released their annual report predicting that, due to slower than expected growth in Medicare spending, the Independent Payment Advisory Board (IPAB) will not be triggered until 2021.
On June 5, CLSA hosted a congressional briefing on the importance of funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).
CLSA continues to lead efforts to build support within the California congressional delegation for the repeal of two policies that harm life sciences investment and innovation: the medical device tax and Independent Payment Advisory Board (IPAB).
CLSA featured in The Los Angeles Times, reacting to the President’s 2018 Budget Request, and what it would mean for the life sciences industry.
California Life Sciences Association (CLSA), the premier public policy advocacy and business leadership trade association representing California’s life sciences industry, today issued the following statement in response to the President’s FY 2018 budget request.
On May 3, 19 members of CLSA’s board of directors spent a full day on Capitol Hill meeting with more than two dozen key members of Congress on issues of importance to California’s life sciences innovation ecosystem.
On May 18, the House Energy & Commerce Health Subcommittee unanimously voted to advance legislation that would reauthorize the U.S. Food and Drug Administration’s (FDA) authority to collect user fees for another five years.
WASHINGTON & BAY AREA, May 9, 2017 – California Life Sciences Association (CLSA), the state’s premier public policy and business solutions organization representing the California life sciences industry, today commended the U.S. Senate’s confirmation of Scott Gottlieb, M.D., as the new commissioner of the U.S. Food and Drug Administration (FDA). As the key federal agency … Continue reading CLSA Applauds Confirmation of Dr. Scott Gottlieb as New FDA Commissioner
New Digital Advocacy “Take Action” Center helps members stay informed about CLSA’s advocacy efforts, view priority legislation, contact their elected officials and more.
CLSA is proud to endorse bipartisan legislation to improve the process for FDA inspections of medical device establishments and granting export certifications. California is home to over 1,700 medical device companies, providing approximately 75,000 jobs in vibrant medical technology clusters up and down the state.
CLSA announces a major expansion to its advocacy team, hiring three new government relations directors based in its Sacramento and Washington, D.C. offices, bringing its in-house advocacy staff count to 9 personnel. Oliver Rocroi has been hired as Senior Director, State Government Relations; Manny Heer has been hired as Director, Alliance Development & Advocacy; and Adam Lotspike has been hired as Associate Director, Federal Government Relations.
CLSA Pres. & CEO Sara Radcliffe pens an op-ed in the San Jose Mercury News calling on Congress to repeal the Independent Payment Advisory Board (IPAB), a controversial advisory board enacted as part of the ACA, which threatens seniors’ care and could harm biomedical innovation by reducing incentives for investment in new research and product development.
On March 16, the President released his budget blueprint for fiscal year (FY) 2018, which proposes deep cuts in funding for federal research at the NIH as well as an increase in FDA user fees.
Leadership of federal departments and agencies with oversight of issues of importance to California’s life sciences sector continue to take shape under the new Trump Administration.
CLSA President & CEO Sara Radcliffe comments on the President’s proposed $6 billion cut to the National Institutes of Health (NIH) in his budget blueprint.
CLSA President & CEO Sara Radcliffe reacts to the President’s proposed $6 billion cut to the NIH’s budget in this San Diego Union-Tribune article.
CLSA’s Jenny Carey and EveryLife Foundation for Rare Diseases’ Julia Jenkins pen an op-ed in The Hill on the need enact sound public policies that help tackle the more than 7,000 rare diseases affecting 30 million people, more than half of whom are children.
On Feb. 16, House Republican leadership distributed a policy brief outlining how they intend to go about repealing and replacing the Patient Protection and Affordable Care Act (ACA) originally enacted in 2010.
Given the medical device excise tax’s disproportionate impact in California, CLSA has been a leading advocate in support of its full repeal. In the 115th Congress, CLSA continues to advocate for a full and permanent repeal of the medical device excise tax.
View CLSA’s 2017 Federal Policy & Advocacy Agenda, to guide our priority policy and advocacy issues, and related education and outreach opportunities.
CLSA’s seasoned federal government relations team is engaged on behalf of the biomedical, agriculture, and industrial biotechnology sectors in multiple ways through strategic collaborations and direct lobbying in Washington, D.C. to advance innovation, investment and job creation for California’s treasured life sciences ecosystem. Our 2017 federal policy agenda drives these goals.
With the opening of the 115th Congress, the 55-Member California congressional delegation continues to rank amongst the most influential, with numerous members serving in positions of leadership and on committees with jurisdiction over issues and policies critical to the continued advancement of our state’s and the nation’s life sciences sector.
San Diego Congressman Named to U.S. House Committee Critical to Continued Success of San Diego’s Life Sciences Community.
The Protect Medical Innovation Act of 2017, introduced today in the U.S. House, would permanently eliminate 2.3% excise tax on medical device manufacturers.
After over two years of work, the 21st Century Cures Act passed both the House and Senate with overwhelming bipartisan support just ahead of the close of the 114th Congress.
President-Elect Donald Trump recently made two nominations to top healthcare positions import to the life sciences sector: Rep. Tom Price (R-Georgia) to serve as HHS Secretary, and Seema Verma to lead CMS.
Last week, the House and Senate passed a Continuing Resolution (CR) to fund the federal government until April 28, 2017.
Bipartisan package of innovative reforms will help propel U.S. life sciences research, investment and innovation.
CLSA is pleased to provide you with this exclusive 2016 federal election update, and what these results mean for California’s life sciences sector.
With 17 propositions on California’s November ballot, there is one that stands out as particularly bad for patients, veterans and taxpayers: Proposition 61.
After weeks of negotiations, the Senate and House finally passed a Continuing Resolution (CR) to keep the government funded and operational through Dec. 9, 2016 (Public Law 114-223). On Sept. 29, the President signed the measure into law, narrowly avoiding a government shutdown.
In September, both the House and Senate passed, and President Obama signed into law S. 1878, the Advancing Hope Act, a bill to renew and extend through the end of this year the rare pediatric disease (RPD) priority review voucher (PRV) program.
CLSA applauds the congressional passage of the Advancing Hope Act, a bill to foster drug development for rare diseases in children.
CLSA identifies several areas of concern and suggestions for improvement regarding the cost and value of new drugs and medical technologies.
During the August Recess, the FDA and industry concluded preliminary negotiations to define the terms under which the agency will be authorized to collect industry-paid user fees to support their review activities on medical devices and prescription drugs and biologics.
This summer, the Institute for Clinical and Economic Review (ICER) released a national call for stakeholder feedback on improvements to their “Value Assessment Framework” (Framework), which underpins the analyses and reports they (including their core California Technology Assessment Forum program) issue on the cost and value of new drugs and medical technologies.
On July 25, CLSA hosted Congresswoman Mimi Walters (R–Laguna Niguel) in San Diego for tours at member companies DexCom and Organovo.
On July 28, CLSA hosted a program on “Pandemic Preparedness: The Public-Private Research and Response Infrastructure” in La Jolla, Calif. Part of CLSA’s Afternoon with Thought Leaders series and held in conjunction with our 3rd quarter Board meeting, the event examined critical partnerships between stakeholders in the numerous public health agencies, non-profits and private industry as well as how our nation’s pandemic preparedness and response infrastructure can be improved.
CLSA strongly supports H.R. 3299, the Strengthening Public Health Emergency Response Act, legislation that would make important improvements to ensure our nation’s biodefense infrastructure is adequately prepared in the event of a bioterrorism or pandemic outbreak.
Complementing the efforts of the House Energy & Commerce Committee’s 21st Century Cures Act passed by the full House of Representatives last summer, this spring the Senate Health, Education, Labor & Pensions (HELP) Committee advanced more than a dozen individual bills intended to eventually be combined into a single legislative package to be passed by the Senate, and then go to conference with the 21st Century Cures Act.
On April 20, Representatives Tony Cárdenas (D-Van Nuys), Charles Boustany (R-La.), Richard Neal (D-Mass.) and Gus Bilirakis (R-Fla.) introduced H.R. 5009, the Ensuring Patient Access to Critical Breakthrough Products Act, legislation to streamline Medicare coverage for technologies approved through the FDA’s medical device expedited review process.
On May 31, Centers for Medicare and Medicaid Services’ (CMS) Acting Administrator Andrew Slavitt sent a response to the May 2, 2016 comment letter initiated by Representatives Tom Price (R-Ga.), Charles Boustany (R-La.), and John Shimkus (R-Ill.) regarding concerns with CMS’ proposed Part B Payment Model.
California Life Sciences Association Expands Advocacy Team. Michael Bolden joins CLSA as Sacramento-Based Sr. Director of State Gov’t Relations. Jenny Carey, Reese Isbell and Will Zasadny promoted.
On April 20, Representatives Tony Cárdenas (D-Van Nuys), Charles Boustany (R-La.), Richard Neal (D-Mass.) and Gus Bilirakis (R-Fla.) introduced H.R. 5009, the Ensuring Patient Access to Critical Breakthrough Products Act, legislation that would streamline Medicare coverage for technologies approved through the FDA’s medical device expedited review process.
In March, the Centers for Medicare & Medicaid (CMS) released a proposed rule that would make extensive changes to the reimbursement of drugs covered under Medicare Part B.
CLSA’s own Eve Bukowski, our VP of State Government Relations and a cancer fighter pens a letter to the editor of CALMatters, which pushes back on a recent article in CALMatters (“California Searches for Prescription to Treat Rising Drug Costs,” April 10) that suggests the state simply could not afford to treat poor patients who need life-saving medicines to treat their serious or even life-threatening illness.
Reps. Susan Davis (D-San Diego), David McKinley (R-W.V.), Andre Carson (D-Ind.), and Peter King (R-N.Y.) led this year’s bipartisan House letter urging $34.5 billion in funding for the National Institutes of Health (NIH) as part of this year’s congressional appropriations process. CLSA has long been a staunch advocate for increased, sustained funding for the nation’s premier biomedical research agency and worked directly with our congressional delegation offices to encourage their support of the letter.
On April 6, the Senate Health Education Labor and Pensions (HELP) Committee completed their third and final mark-up of bills related to their “innovation initiative” agenda, passing five additional pieces of legislation with bipartisan support.
CLSA Pres. & CEO Sara Radcliffe chats with the San Diego Business Journal on the impact that the newly permanent R&D Tax Credit will have on life sciences organizations in San Diego and California.
To ensure that our activities in the coming year reflect your perspectives and needs, CLSA is pleased to present our 2016 federal, state and local policy agendas.
On Feb. 29, the California Life Sciences Association (CLSA) and the EveryLife Foundation for Rare Diseases authored an op-ed in The Hill. “Reinvigorating the Fight Against Rare Diseases” was published on World Rare Disease Day, and highlights the importance of continued investment into research and development of new therapies and cures for rare diseases, which affect approximately 1 in 10 Americans and their families.
On Feb. 24, the Senate confirmed Dr. Robert Califf, as the new U.S. Food and Drug Administration (FDA) Commissioner by a vote of 89-4.
A Letter to the Editor authored by CLSA President & CEO Sara Radcliffe was published in the Los Angeles Daily News. This letter responds to an opinion piece originally published February 18 by Heidi Sanborn, executive director of the California Product Stewardship Council, a key group pushing the local takeback initiatives in California.
California Life Sciences Association statement on the U.S. Senate confirmation of Dr. Robert Califf to be the next Commissioner of the U.S. Food and Drug Administration (FDA).
On Feb. 9, 2016, President Barack Obama released his $4.1 trillion budget request for fiscal year (FY) 2017. For your convenience, CLSA has prepared a detailed summary and analysis of the President’s budget request’s many provisions of importance to the life sciences sectors.
Following a series of stakeholder hearings, Board of Supervisors meetings, and staff discussions in which CLSA has taken an active part, Los Angeles County’s Extended Producer Responsibility Working Group proposed its final draft ordinance on drug and sharps takeback in January.
After nearly a year awaiting for a comprehensive draft of the Senate Innovation Initiative (the Senate’s separate but companion effort to the House-passed 21st Century Cures Act), Senate HELP Committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) late last month announced the committee would be moving its initiative forward by advancing individual pieces of legislation to be considered in three separate mark-ups this spring.
Last month, Rep. Lloyd Doggett (D-Texas) led a letter asking the U.S. Department of Health & Human Services (HHS) and the National Institutes of Health (NIH) to assert “march-in rights” to address the issue of prescription drug costs and access.
In Dec. 2015, President Obama signed a nearly $2 trillion spending package to fund the federal government through fiscal year (FY) 2016 that suspends the 2.3% medical device excise tax.
While CLSA’s “Value of Innovation” campaign was initially launched with a focus on the public and political debate around drug prices in California, the debate has now descended upon Washington and will continue to be an issue of focus not only in Sacramento but for Congress – as well as the Presidential candidates – in 2016.
CLSA statement on proposed delay of the 2.3% medical device tax as part of year-end tax agreement in Congress.
With the current Continuing Resolution (CR) set to expire on Dec. 11 and several tax credits expiring at the beginning of 2016, Congress is spending its last week of session working toward a number of must-pass measures to close out 2015.
On Oct. 28, the U.S. House of Representatives voted to approve a budget deal that raises the nation’s debt ceiling through March 2017. The measure also increases federal spending on defense and domestic programs over $80 billion for the next two years, which should benefit such CLSA priorities as NIH funding.
Developed in collaboration with The Boston Consulting Group, with input and cooperation from the FDA, CLSA last month released a report, “Recent Trends in FDA Medical Device Regulation,” utilizing the FDA’s publicly available data to evaluate FDA’s regulatory review processes for medical devices. The report examines premarket approval (PMA) review times, 510(k) decision times, and variations in performance across the FDA’s Center for Device and Radiological Health (CDRH) review divisions and branches.
CLSA President & CEO Sara Radcliffe comments on the establishment of the Congressional Life Science Caucus.
CLSA commends Reps. Scott Peters (D-CA) and Leonard Lance (R-NJ) on the creation of the Congressional Life Sciences Caucus, which will help strengthen the dialogue in Congress over the issues affecting the life sciences sector.
CLSA Pres. & CEO Sara Radcliffe speaks with The BIO Report to discuss some of the key policy issues facing the biotechnology innovation ecosystem. This podcast covers a variety of public policy issues, including PDUFA VI, Trans Pacific Partnership (TPP) and the 21st Century Cures Act.
New California Life Sciences Association (CLSA) and Boston Consulting Group (BCG) report shows progress made, but room for improvement remains in FDA medical device review times.
California Life Sciences Association (CLSA) and Boston Consulting Group (BCG) report finds progress made in FDA medical device review times, but room for improvement remains
Earlier this month, the 12 Pacific Rim countries negotiating the Trans-Pacific Partnership (TPP) reached an agreement to improve trade throughout the region. CLSA has been closely monitoring these negotiations due to the significant impact the terms will have on the life sciences sector.
On Sept. 30, Congress passed a Continuing Resolution (CR) and avoided a government shutdown. The Senate passed the CR by a vote of 78-20, and the House passed the measure by a vote of 277-151.
Via Legal Newsline, two groups representing California’s life sciences sector say they are disappointed with recent remarks by U.S. Rep. Darrell Issa about a House-introduced patent reform bill.
Recently, the FDA announced the formation of the Patient Engagement Advisory Committee (PEAC) and requested public comments on what topics the committee should consider, which are due November 20th. FDA also published three requests for nominations to serve on the committee, including one for industry members which is due October 21st.
According to CLSA & Biocom, Issa’s remarks dismissive of concerns of life sciences sector in San Diego and across California SOUTH SAN FRANCISCO & SAN DIEGO – Sept. 21, 2015 – California Life Sciences Association (CLSA) and Biocom delivered a letter to Rep. Darrell Issa (R-CA) expressing disappointment with recent remarks, reported in POLITICO, regarding … Continue reading CLSA & Biocom Respond to Rep. Darrell Issa on Patent Litigation Legislation Comments
CLSA President & CEO Sara Radcliffe and Biocom President & CEO Joe Panetta respond to comments Rep. Issa made in a Politico Pro, alleging that opponents of pending patent litigation reform legislation (H.R. 9) have spread “misinformation” about the bill. Issa’s remarks are dismissive of concerns of life sciences sector in San Diego and across California
Late last month, the FDA released long-awaited documents outlining the agency’s current thinking on the naming of biosimilars.
CLSA is actively opposing H.R. 9, the so-called Innovation Act, legislation that contains patent litigation-related provisions that would threaten the ability of biomedical innovators to enforce their patents and fund continued R&D by making it more difficult, time-consuming and expensive to enforce legitimate and important IP rights.
Update on H.R. 1599, legislation that ensures safe, effective and streamlined nationwide standards for GMO food labeling.
CLSA President & CEO Sara Radcliffe pens an op-ed in The Sacramento Bee regarding H.R. 9, federal legislation that would weaken the process that turns research into products, new companies.
Paul Hastings, CLSA Board Member and OncoMed Pharmaceuticals Chairman & CEO, pens an op-ed in the San Francisco Business Times calling on Congress to safeguard and preserve our patent system. Failure to do so would be be a blow to our role as the world’s leader in life sciences innovation.
In each issue of our CLSA Advocacy Wire, we will highlight a new member of California’s six-member “freshman class” in the 114th Congress. In July, we spotlight the career of Rep. Norma Torres.
On July 10, the House of Representatives passed H.R. 6, the 21st Century Cures Act, by a vote of 344-77. Passage of this legislation is top priority of CLSA. The bill is aimed at accelerating the pace of biomedical innovation and cures by modernizing federal research and regulatory policies. This initiative was the result of more than a year of work by Energy & Commerce Committee Chairman Fred Upton (R-Mich.) and Rep. Diane DeGette (D-Colo.). CLSA contributed feedback throughout the process and were pleased to see several recommendations reflected in the passed legislation.
On July 10, the House overwhelmingly approved the 21st Cures Act, a comprehensive legislative package to accelerate the pace of biomedical research and development in the U.S. CLSA President & CEO Sara Radcliffe comments on the passage of this landmark legislation.
CLSA is actively opposing H.R. 9, the so-called Innovation Act, legislation that contains patent litigation-related provisions that would threaten the ability of biomedical innovators to enforce their patents and fund continued R&D by making it more difficult, time-consuming and expensive to enforce legitimate and important IP rights. We continue to work stakeholders and members of the California congressional delegation to advocate for changes to the legislation that would both strengthen patent protections and curb abusive litigation practices by “patent trolls” for all patent holders and industry sectors.
The 21st Century Cures legislation, now targeted for a House floor vote in July, would give NIH a separate $8.75 billion over five years, according to this Politico article by Sarah Karlin.
On June 18, the House passed critical legislation to renew the Trade Promotion Authority (TPA) by a vote of 218 to 208. The Senate also moved to passed TPA, by a vote of 60 to 38 on June 24. CLSA was supportive of H.R. 2146, the Trade Priorities and Accountability Act, and worked with the California delegation in informing them of the important provisions in TPA that would allow the Administration to better protect IP rights and fair market access when negotiating trade deals.
CLSA strongly supports a full repeal of the medical device tax, and urged members of the California congressional delegation to vote in support of H.R. 160, the Protect Medical Innovation Act of 2015. On June 18, H.R. 160 passed by the House of Representatives by a veto-proof majority vote of 280 to 140 — 27 bipartisan members of the delegation ultimately voted in favor of the bill.
California Life Sciences Association (CLSA) statement on House Judiciary Committee passage of H.R. 9, the so-called “Innovation” Act. Without substantial changes, the legislation jeopardizes America’s leadership in life sciences research, investment and innovation.
CLSA President & CEO Sara Radcliffe pens an exclusive op-ed in Roll Call applauding the 21st Century Cures Act. This landmark package of legislation includes a series of improvements to the healthcare system that will improve the lives of millions around the world, by accelerating the pace of drug, device and diagnostics discovery and development.
CLSA is actively opposing H.R. 9, the so-called Innovation Act, legislation introduced by House Judiciary Committee Chairman Bob Goodlatte (R-Va.). In its current form, the legislation contains patent litigation-related provisions that would threaten the ability of biomedical innovators to enforce their patents and fund continued R&D
In each issue of our CLSA Advocacy Wire, we will highlight a new member of California’s six-member “freshman class” in the 114th Congress. In June, we spotlight the career of Rep. Ted Lieu.
CLSA is supportive of pending legislation to renew Trade Promotion Authority (TPA), which contains a number of provisions that would allow the Administration to better protect IP rights and fair market access when negotiating trade deals.
CLSA board members met with dozens of key Members of Congress and senior staff on Capitol Hill; more than 150 guests attended May 13 reception and private Board dinner events marking the official public launch of CLSA.
CLSA strongly supports a full repeal of the medical device tax, and is urging members of the California congressional delegation to vote in support of H.R. 160, the Protect Medical Innovation Act, when it is brought to the full House for a vote as early as the week of June 15.
Rep. Suzan DelBene, Rep. Kyrsten Sinema and Rep. Scott Peters pen an op-ed in The Huffington Post on the need to repeal the medical device tax. Doing so would stimulate our economy, strengthen America’s global leadership, and invest in a brighter tomorrow.
The 21st Century Cures Act is not only visionary, but critical to ensuring that California and our nation remains the worldwide leader in life sciences research, investment and innovation.
Rep. Scott Peters (D-San Diego) led a group of 18 freshman and sophomore House Democrats in sending a letter to congressional leadership, urging action on legislation to fully repeal the medical device excise tax (H.R. 160, the Protect Medical Innovation Act of 2015)
CLSA is leading the charge to defeat H.R. 9, the so-called Innovation Act, legislation that contains patent litigation-related provisions that would threaten the ability of biomedical innovators to enforce their patents and fund continued R&D by inadvertently making it more difficult, time-consuming and expensive to enforce legitimate and important IP rights.
Rep. Knight represents the 25th Congressional District, including the cities of Santa Clarita, Simi Valley, Palmdale and Lancaster. Prior Congress, Rep. Knight spent 18 years as a sworn police officer in the Los Angeles Police Department.
CLSA led a multi-state and regional life sciences association letter of endorsement for H.R. 1078, the FDA Safety Over Sequestration (SOS) Act, legislation to exempt FDA industry-paid user fees from sequestration.
Landmark legislation will modernize biomedical discovery, development and delivery to bring new therapies and cures to patients.
CLSA is co-hosting multi-state life sciences association congressional briefing in Washington DC. This briefing will highlight the critical role of FDA user fees in the development of and patient access to new treatments and cures.
House and Senate Approve $1.1 trillion “Cromnibus” Following the Nov. 4 mid-term elections, Congress reconvened for a lame-duck session to consider a Fiscal Year 2015 spending bill before the previous Continuing Resolution (CR) expired on Dec. 11, 2014. Congressional leaders unveiled a $1.1 trillion spending bill early last week that included a number of important … Continue reading Washington Report — Dec. 17, 2014: House and Senate Approve $1.1 Trillion “Cromnibus”
California Congressional General Election Recap The Nov. 4 elections brought sweeping changes to the balance of power in Washington. In the House, Republicans increased their advantage, adding at least 10 seats to expand their majority. In the Senate, GOP candidates took control of seats held by Democrats in eight states – more than enough to … Continue reading Washington Report — Nov. 14, 2014
The Nov. 4 elections brought sweeping changes to the balance of power in Washington. In the House, Republicans increased their strong advantage, adding at least 10 more seats to expand their majority. In the Senate, GOP candidates took control of seats held by Democrats in at least seven states – more than enough to seize … Continue reading 2014 Federal & State Election Roundup
Shutdown destined to slam medical research San Francisco Business Times By Ron Leuty http://www.bizjournals.com/sanfrancisco/blog/biotech/2013/10/shutdown-sequester-joe-derisi-ucsf-nih.html US shutdown threatens to disrupt FDA PM Live By Phil Taylor http://www.pmlive.com/pharma_news/us_shutdown_threatens_to_disrupt_fda_506923 Government Shutdown Hits Research, Teaching Hospitals, Residency Programs Forbes By Bruce Japsen http://www.forbes.com/sites/brucejapsen/2013/10/01/government-shutdown-hits-research-teaching-hospitals-residency-programs/ Wondering about a government shutdown? First thing to know: It all won’t disappear The Washington Post … Continue reading Federal Government Shutdown News Roundup
ANGELIDES BEATS WESTLY IN DEMOCRATIC PRIMARY: State Treasurer Phil Angelides won the Democratic gubernatorial primary election over state Controller Steve Westly by a margin of 47.9 percent – 43.4 percent. The election was characterized by low turnout, with just over one-third of eligible voters casting ballots. One explanation for voter apathy was the extraordinarily negative … Continue reading CHI Bulletin — **Special Edition** June 7, 2006 * Vol. 12, No. 4