California’s new Consumer Privacy Act (AB 375), the toughest data privacy law in the nation, will impose stringent new requirements on the state’s high-profile tech companies in 2020. Its impacts on the life sciences industry, though, remain unclear. CLSA’s State Government Relations team sat down with BioWorld to discuss what the measure means for innovative biomedical companies.
CLSA’s Weekly Sacramento At-A Glance Newsletter provides our membership with the latest happenings for the life sciences sector in the California State Government.
On Friday, July 13, California’s Office of Statewide Health Planning and Development (OSHPD) posted for public comment (available here) its official rulemaking package for implementing Senate Bill 17 in California.
California’s Proposition 65 requires businesses to provide warnings with products or at facilities if they contain any chemicals (out of a list of around 900) at levels above specified safe harbor levels.
According to Kaiser Health News, patients overpay for prescriptions 23% of the time. Check out CLSA’s infographic calling for more accountability of Pharmacy Benefit Managers (PBMs).
The California Legislature voted to approve a budget deal on June 14 between Democratic legislators and Governor Jerry Brown, which will be his last budget as governor. The budget was passed hours prior to the June 15 at midnight deadline, includes several significant wins for the life sciences sector.
As results from yesterday’s California Primary Elections continue trickling in, CLSA’s state government relations team would like to share a brief update on some anticipated changes in the makeup of the California Legislature, and offer additional details on several key California races you may be interested in.
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).
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.
Despite California’s significant budget surplus, legislators are continuing to propose burdensome taxes affecting the life sciences industry, among many others. The two tax bills most recently raising alarms among CLSA staff and membership are Senate Bill 993 (Hertzberg) and Assembly Bill 2731 (Gipson).
AB 3087 would create a California commission to set commercial rates for health plans, providers, and hospitals in an attempt to curtail health care costs. CLSA has considered the bill as a blunt instrument for an incredibly complex issue and consequently likely to result in substantial unintended consequences, many of which could impact patient care in California for many years to come.
Last year, Governor Brown signed Senate Bill 17 in law, which requires manufacturers to provide a 60-day advance notice of any price increase on a drug to all California public agency purchasers, health insurers, and pharmacy benefit managers (PBM) if that drug’s price has increased 16 percent or more cumulatively over the previous two calendar years, including the current year’s increase.
On April 18, CLSA partnered with the Lawrence Berkeley National Labs and the Council on Competitiveness to provide a briefing to members and staff of the California State Legislature on the status of California’s bioeconomy.
Governor Jerry Brown will be termed out this November, setting the stage for over 50 candidates who have filed statements of intention, though only a few have reported any noteworthy fundraising activity.
2018 presents many unique political opportunities for California. With three special elections to fill recent vacancies in the legislature, a gubernatorial race, and a host of ballot measures, the results of 2018 are certain to change the political landscape for the foreseeable future.
As of March 31, five statewide ballot propositions had been certified for 2018. The state legislature has until Aug. 31, 2018, to refer additional propositions for the ballot. A summary of these propositions are below.
The CLSA PAC is gearing up for multiple events in the upcoming quarter, including events for Senator Dr. Richard Pan, Assemblymember Marc Berman, Assemblymember Cecilia Aguiar-Curry, Assemblymember Blanca Rubio, and a candidate from the Senate District 22, Susan Rubio.
Contributing to CLSA PAC has never been easier. This year, CLSA PAC added an online form feature to its website where you can make a contribution in three simple steps.
CLSA’s Political Action Committee (CLSA PAC) has been identifying candidates who are supportive of our industry and can become our champions in the California State Legislature. The PAC has held multiple meet and greets with incumbents and special election candidates as we ramp up for the 2018 elections.
CLSA’s quarterly PAC newsletter aims to provide you with the latest information about the elections, CLSA PAC events and other political developments in the state of California.
On March 12, the California State Assembly released its report summarizing findings and recommendations from six hearings held by the Assembly’s Select Committee on Health Care Delivery Systems and Universal Coverage over the past few months.
Last year, Governor Brown signed Senate Bill 17 (Hernandez) into law. The law requires manufacturers to provide a 60-day advance notice of any price increase on a drug to all California public agency purchasers, health insurers, and pharmacy benefit managers (PBM) if that drug’s price has increased 16 percent or more cumulatively over the previous two calendar years, including the current year’s increase.
On Feb. 7, CLSA held its annual Back to Session Reception to welcome legislators back to Sacramento for the commencement of another legislative year, as well as to honor those legislators identified by CLSA membership as Life Sciences Champions. Dozens of legislators and at least two hundred other attendees packed the Ella Dining Room and Bar to see the presentation and mingle with those representing the life sciences industry, among others.
Following the Feb. 16 deadline for submitting new legislation to be considered for enactment this year, CLSA expects to see more than a dozen bills related to opioids when the dust settles. The ultimate number of bills dealing with the subject will not be apparent immediately, as many are introduced in a generic format, which is called a “spot bill,” and later amended with more specific language.
Legislators Honored with Award for Commitment to Strengthening California Life Sciences Sector at CLSA’s Back to Session Reception in Sacramento
On Jan. 18, Assemblymembers Kevin McCarty (D-Sacramento) and Phil Ting (D-San Francisco) introduced Assembly Constitutional Amendment 22, which would raise corporate taxes on California companies with annual net revenues higher than $1 million. The state tax increase on these corporations is intended to be equivalent to half of the federal tax cut recently signed into law.
While several opioid-related bills were introduced last year in California’s legislature, many in Sacramento anticipate a double-digit number of opioid-related bills to be introduced this year.
CLSA today issued the following statement applauding Governor Jerry Brown’s 2018 – 2019 California budget proposal that calls for $30 million to be invested in precision medicine research and the establishment of the California Institute to Advance Precision Health and Medicine (CIAPHM).
On Dec. 8, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the United States District Court for the Eastern District of California, seeking to have Senate Bill (SB) 17’s manufacturer reporting requirements declared unconstitutional and void.
Shortly before Thanksgiving, California’s Office of Statewide Health Planning and Development (OSHPD) released its implementation plan for Senate Bill 17 (Hernandez). The bill was signed into law in October, and its advance notice provisions take effect on Jan. 1, 2018.
Despite the best efforts of CLSA and its partner trade associations, both Senate Bill 17 (Hernandez) and Assembly Bill 265 (Wood) reached the Governor’s desk and were signed into law.
In addition to Senate Bill 790 (McGuire), which was discussed in last month’s bulletin, several bills on which CLSA was active failed to become law this year. Unlike SB 790, these were bills CLSA had supported to varying degrees during the legislative process.
On Sept. 11, Senate Bill 790 (McGuire) was placed on the inactive file, meaning that, while the bill is dead for this year, it will be eligible to be heard again once the legislature reconvenes in early January 2018.
Despite the best efforts of CLSA and its partner trade associations, Senate Bill 17 (Hernandez) has reached the Governor’s desk. Gov. Brown has until Oct. 13 to sign the bill for it to become law. If it’s signed, the advance notice requirements, as discussed below, would become effective on Jan. 1, 2018.
CLSA’s Brett Johnson provides analysis to The Mercury News on Senate Bill 17, legislation pending in Sacramento that will harm patient access to care and biotechnology innovation in California.
“Californians have legitimate concerns about access to affordable drugs, but SB 17 does not address them. It is a bad deal for business and does nothing to benefit patients.” – William J. Newell, CEO, Sutro Biopharma & Vice Chairman, California Life Sciences Association.
“As an early-stage company CEO, I’m afraid that SB 17 will increase uncertainty and stifle investment that companies like ours rely on to develop new drugs.”
“Cancer is frightening in the abstract, and even more so when it becomes your reality. Three years ago, I was diagnosed at a relatively young age with late-stage colon cancer and have since gone through extensive treatments.”
CLSA’s Brett Johnson, Senior Director of Policy and Regulatory Affairs, was featured on KSRO 103.5 FM/1350 AM Sharing Life Sciences Sector Concerns With SB 17.
CLSA’s Brett Johnson provides analysis to the LA Times on priority legislation in Sacramento for the life sciences sector.
CLSA has been working hard in opposition to the two biggest bills for the life sciences sector this year, Senate Bill 17 (Hernandez) and Senate Bill 790 (McGuire).
Assembly Bill 602 (Bonta), a bill sponsored by CLSA, was recently signed into law by Governor Jerry Brown. The law, which is already in effect due to an urgency clause, prohibits pharmacies from submitting insurance claims for diabetes test devices, such as blood glucose testing strips, acquired from unauthorized distributors.
Sponsored by CLSA, AB 602 Protects Patients with Diabetes from Counterfeit or Improperly Sold Diabetes Test Devices
As California’s legislature heads into its break for the summer, returning on Aug. 21, the top three bills of concern to the life sciences industry all face the potential for amendments before reaching their respective final floor votes.
On July 14, 2017, CLSA partnered with Organovo, Takeda and Sanford Burnham Prebys to host a tour for members of the California Legislative Technology and Innovation Caucus.
CLSA’s Brett Johnson provides analysis to the San Francisco Business Times on three major bills (SB 790, SB 17 and AB 215) the life sciences sector is facing in Sacramento.
California policymakers are considering legislation (SB 790) that would restrict the California life sciences sector’s ability to provide continuing education to physicians and discuss the clinical benefits of medicines.
On June 27, two bills with significant negative consequences for the life sciences industry, Senate Bill 17 (Hernandez) and SB 790 (McGuire), were passed out of California’s Assembly Health Committee.
California Life Sciences Association (CLSA) applauds Governor Jerry Brown, California State Senate and California Assembly leaders for their strong support of life sciences innovation, as demonstrated again in this year’s 2017-2018 budget deal which allocates a $10 million investment in precision medicine research.
CLSA President & CEO Sara Radcliffe pens a letter to the editor of The Sacramento Bee, responding to an op-ed by Sen. Ed Hernandez on SB 17, a bill being deceptively sold under the label of drug pricing transparency.
Taking a look beyond CLSA’s two most significant legislative battles of the year, Senate Bill 17 (Hernandez) and Assembly Bill 265 (Wood), CLSA notched a significant victory against opioid taxes, though the fight against state-level restrictions on physician payments has grown in intensity.
David Beier of the VC firm Bay City Capital, pens an op-ed in the San Francisco Chronicle outlining the flaws of Senate Bill 17.
New Digital Advocacy “Take Action” Center helps members stay informed about CLSA’s advocacy efforts, view priority legislation, contact their elected officials and more.
The third week of April marked the first policy committee hearings on the top two bills of interest for CLSA this year, Senate Bill 17 (Hernandez) and Assembly Bill 265 (Wood). These hearings signify a difficult battle ahead for the life sciences sector in this legislative session.
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.
Last August, State Senator Ed Hernandez (D-Asuza) pulled his drug price reporting legislation — Senate Bill (SB) 1010 — after the bill was amended in the Assembly Appropriations Committee. On March 15, he introduced SB 17, which is a somewhat modified version of last year’s bill.
Asm. Jim Wood (D-Healdsburg), Chair of the Assembly Health Committee, is preparing Assembly Bill (AB) 265 (drug coupons) to be heard in his committee at some time in April.
CLSA’s California Life Sciences Industry report featured in Trade & Industry Development on the strength of California’s life sciences sector.
CLSA’s Brett Johnson, Sr. Director of Policy & Regulatory Affairs, provides analysis and cites concerns regarding Assembly Bill 265, legislations introduced in the California state legislature that would ban drug companies from offering consumers coupons for drugs that have a lower cost alternative.
CLSA’s seasoned state government relations team is engaged on behalf of the life sciences sector in multiple ways through strategic collaborations and direct lobbying in Sacramento to advance innovation, investment and job creation for California’s treasured life sciences ecosystem. Learn more about our 2017 state policy goals.
California Assembly Health Committee Chair, Asm. Jim Wood (D-Healdsburg), has opened this year’s legislative session with drug costs in his crosshairs, introducing two bills and holding hearings related to the subject.
Legislators Honored for Commitment to Strengthening and Promoting California Life Sciences Sector
With the election of what should be the largest class of new legislators until 2024, the overwhelming majority of legislators are now serving under the new 12-year term limit, and the Legislature’s composition is generally set for the next seven years.
Against an evolving legislative and political backdrop, the health plans and labor unions continue their unrelenting campaign to convince policymakers that the price of medicinal therapies is the primary driver of cost increases in the healthcare system.
CLSA was recently featured in a California Healthline article regarding SB 17, a bill introduced by State Sen. Ed. Hernandez pertaining to state drug pricing reporting.
CLSA is pleased to provide you with this exclusive 2016 state 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.
With the continued public and political furor over the price increases of the EpiPen Auto-injector and drug pricing generally, the California state Senate Health Committee held an informational hearing in Los Angeles on Sept. 30. to obtain information and perspectives directly from the public, as well as consider and discuss possible solutions from advocates.
The Legislature concluded its work for this two-year cycle during the early hours of Sept. 1. CLSA’s State Government Relations (SGR) team aggressively engaged on a number of legislative and regulatory items and is proud of the accomplishments made this year on behalf of our members, as we now turn our attention to the challenges awaiting us in the next legislative session.
CLSA Pres. & CEO Sara Radcliffe pens a letter to the editor of The Sacramento Bee responding to their Aug. 11 editorial endorsement of SB 1010, flawed legislation that could enable speculative buying of medicines, creating shortages and leading to growth in “gray markets” where medicine is sold to the highest bidder.
On August 1, the California State Legislature returned from Summer Recess to wrap up work on all remaining legislation by Sept. 1.
Senate Bill 1010 is heading into its final committee hearing in the Assembly Appropriations Committee, which should occur in early August. If the bill survives this hearing, it would move on to the Assembly floor for a final vote in August to determine whether it goes to the Governor.
CLSA’s sponsored bill, Assembly Bill 2115, passed out of Senate Health Committee unanimously on June 29, and now moves on to Senate Appropriations for a hearing in early August.
CLSA featured in The Associated Press regarding life sciences sector concerns with SB 1010.
California Life Sciences Association (CLSA), the statewide public policy organization representing over 750 of California’s leading life sciences innovators, today issued the following statement regarding Senate Bill (SB) 1010, which passed by the California Assembly Health Committee yesterday. SB 1010 prioritizes paperwork, red tape and bureaucracy over research, and instead of improving patient access and affordability, places patients in California at risk. This statement can be attributed to Sara Radcliffe, President & CEO, California Life Sciences Association (CLSA).
California NAACP joins the California Chronic Care Coalition, California Senior Advocates League, Friedreich’s Ataxia Research Alliance (FARA), Council for Citizens Against Government Waste, TechNet, California Hepatitis C Task Force and others to voice concerns regarding SB 1010, a bill by State Sen. Ed Hernandez, which prioritizes paperwork, red tape and bureaucracy over research, and instead of improving patient access and affordability, places patients in California at risk.
CLSA Pres. & CEO Sara Radcliffe pens an op-ed in The Sacramento Bee on the pitfalls of SB 1010, flawed legislation that could hinder patient access to care in California.
State legislation we have previously reported on, Senate Bill (SB) 1010, will be heard in California’s Assembly Health Committee on Tuesday, June 21.
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.
Bridget Hood, a patient advocate, pens an op-ed in The Orange County Register calling on elected officials in Sacramento and Washington D.C. to not make any kinds of policy decisions that could weaken access or slow down medical innovation, but instead, help turn the hope for miracle medicines into a reality by moving medical innovation forward.
On April 22, CLSA hosted California State Senator Ted Gaines (R-El Dorado) in San Diego for tours at member companies Vertex Pharmaceuticals and Organovo.
Problematic legislation, Senate Bill 1010, continues to make its way through the California Senate.
New bill would require a manufacturer to provide a 60-day notice to all payers in California and the chairs of all fiscal committees in the state legislature if the price of a drug increases more than 10 percent in a 12-month period or if a drug will be marketed at an initial price of $10,000 or more annually or per course of treatment.
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.
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.
The California Life Sciences Association (CLSA) participated in the California Rare Disease Day State House Event on February 29th, proclaiming the date as Rare Disease Day in California, as acknowledged in Senate Concurrent Resolution (SCR) 108, authored by Senator Bill Monning (D – Carmel) and co-authored by Assemblymember Katcho Achadjian (R – San Luis Obispo).
On Feb. 29 at the State Capitol, the California Life Sciences Association (CLSA) participated in an event recognizing Feb. 29 as Rare Disease Day in California as acknowledged in Senate Concurrent Resolution 108, authored by Senator Bill Monning (D – Carmel) and co-authored by Assemblymember Katcho Achadjian (R – San Luis Obispo).
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.
On Feb. 3, CLSA celebrated the value of medical innovation with state public policy and industry leaders in California’s life sciences sector.
On Jan. 12, AB 463, the so-called Pharmaceutical Cost Transparency Act, died in California’s Assembly Health Committee when the author, Asm. David Chiu (D – San Francisco), decided not to put the bill up for a vote, stating that he did not have the votes to pass it.
On Jan. 7, Governor Jerry Brown released his 2016 – 2017 budget proposal, which includes $10 million for precision medicine research.
On Nov. 4, CLSA partnered with the California Legislative Staff Education Institute (CLSEI) to host a tour and educational briefing for 25 key bipartisan legislative staff members from the State Assembly and Senate. Top staff from the policy, fiscal, budget, and leadership offices in addition to the Legislative Analyst’s Office (LAO) participated in the program.
The California Legislature wrapped up the 2014-2015 legislative session on Friday, Sept. 11. Our state legislative committee (SLC) and Sacramento policy and advocacy teams tracked more than 70 bills, took positions on 40 bills, and were active on some of the most high profile and contentious legislation moving this year.
Sara Radcliffe, president and CEO of the California Life Sciences Association, discusses the so-called “California Drug Price Relief Act” with the San Francisco Business Times.
Two measures of note are Senator Jerry Hill’s (D—San Mateo) SB 671, the biosimilars bill, and Speaker Toni Atkins’ (D—San Diego) AB 437, the research and development grant program for small companies.
During the past six months, the California Life Sciences Association Political Action Committee (CLSA PAC) has worked to host numerous events for state legislators and legislative candidates.
AB 339 generally requires that copayments, coinsurance and other cost sharing imposed by health insurers for outpatient prescription drugs be “reasonable.”
A top priority for CLSA, SB 671 updates the Pharmacy Practices Act to establish the procedures and conditions for when a pharmacist may substitute interchangeable biosimilar products that are approved by the Food and Drug Administration. The legislation passed the Assembly Business and Professions Committee on July 7.
CLSA members participate in our June Monthly Speaker Series with the Asian Pacific Islander Caucus to discuss access to quality healthcare issues, the value of medical innovation, and avenues to create employment opportunities for college graduates.
CLSA’s Sacramento team continues to organize meetings with key legislators and staffers for our members to discuss issues concerning the life sciences sector. On June 8, several CLSA members participated in a Meet & Greet with Senator Connie Leyva (D—Chino).
AB 45 and AB 1159 are related to the collection of Household Hazardous Waste (HHW) and were not submitted for a vote in the Assembly Appropriations Committee. This lack of action makes these bills ineligible to be further considered until 2016. CLSA remains actively involved in these conversations seeking reasonable solutions on these important bills.
On May 27, CLSA members had the opportunity to discuss healthcare issues, the importance of innovation and the increased need for patient access to drugs with Deputy Legislative Secretary Donna Campbell as part of our ongoing Sacramento Speaker Series.
Legislation permitting a pharmacist to fill a prescription with a biological product cleared the Senate Business and Professions Committee.
AB 463 author Asm. David Chiu withdrew his bill after it became clear that he would not be able to pass the bill through the Assembly Health Committee. CLSA is confident that some form of this bill will emerge either later this year or at the beginning of next year.
AB 45 and AB 1159 are moving through the Assembly in an attempt to address the issue of extended producer responsibility (EPR). CLSA is actively involved in discussions seeking reasonable solutions on these important bills.
AB 170 aims to transform the state’s newborn blood testing program from an “opt out” to an “opt in” program, reduced the number of newborns being tested for genetic diseases and imposed new conditions on the use and storage of blood samples for medical research.
AB 374 requires insurers to expeditiously grant a patient’s step therapy override determination request when accompanied by supporting rationale and documentation from the prescribing physician.
Among other things, AB 339 requires that copayments, coinsurance and other cost sharing for outpatient prescription drugs be “reasonable” and prohibits an insurer from placing most or all of the drugs to treat a single condition on the highest tier of a formulary unless there is a therapeutic equivalent drug available in a lower cost tier.
CHI’s State Legislative Committee (SLC) Reviews Legislation for 2015 On March 9, CHI members met to analyze the immense number of bills introduced for this legislative year. After sifting through hundreds of bills, CHI is currently tracking 64 bills that directly impact the life sciences industry and its member companies/institutions. As we continue to watch … Continue reading Sacramento at a Glance — March 20, 2015 — CHI’s State Legislative Committee (SLC) Reviews Legislation for 2015
Deadline to Introduce Bills in Sacramento Feb. 27 was the deadline for state lawmakers to introduce the bills they will consider for the current legislative year. From now until Sept. 11, 2015, legislators have the time to send these measures to the Governor for a signature or veto. For the past several weeks and throughout … Continue reading Sacramento at a Glance — March 6, 2015 — Deadline to Introduce Bills in State Legislature; Merger Update
Monthly Speaker Series with Assembly Appropriations Committee Chair Jimmy Gomez At our February Monthly Speaker Series, Assembly Appropriations Committee Chair Jimmy Gomez engaged with a room full of CHI members about the rising cost of healthcare and the Appropriations Committee’s effects on public policy. Assemblymember Gomez recognizes the importance of the life sciences industry to … Continue reading Sacramento at a Glance — Feb. 23, 2015 — CHI Hosts Asm. Jimmy Gomez, Chair of the Appropriations Committee
Over 60 Legislators attend CHI’s Back to Session Reception On Jan. 21, CHI celebrated the value of innovation with state public policy and industry leaders in California’s life sciences sector. More than 60 legislators from both the Senate and the Assembly, legislative staff, biomedical industry executives, academic leaders and the patient community attended the Back … Continue reading Sacramento at a Glance — Over 60 Legislators attend CHI’s Back to Session Reception
2014 has been an important year for California’s life sciences industry. Issues that directly impact our industry, such as healthcare reform, patient access, taxes and the environment have all been front and center. 2015 will present many of these same challenges, and many new ones. It is critical for us to identify and recognize those … Continue reading Sacramento at a Glance — California Legislature Reconvenes