When Congress returns from the District Work period (“August recess”) in September, there will be only 10 legislative weeks remaining for Congress to take action to prevent the Medical Device Excise Tax from going back into effect on January 1, 2020. CLSA has worked closely with our membership, our national trade association partners, allied stakeholders and congressional champions to introduce the Protect Medical Innovation Act of 2019 (H.R. 2207), which would permanently repeal this innovation stifling tax.
After reaching a deal with the White House, on Thursday, July 25 – a day before Congress departs for the August District Work Period – the House of Representatives voted 284 to 149 to pass a bipartisan two-year budget and to extend the debt limit through July 31, 2021.
On July 16, Senator Kamala Harris (D-CA) released a plan proposing international price controls as part of her solution to lower drug costs. This latest action demonstrates growing bipartisan interest in using the dangerous concept of price controls as a mechanism for lowering list prices for pharmaceuticals in the U.S.
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 Congresswoman Katie Porter (D-Irvine). We look forward to working with Congresswoman Porter and her team to advance policies that improve patient health and bring positive change for California patients and their families.
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 Mike Levin (D-San Juan Capistrano). We look forward to working with Congressman Levin and his team to advance policies that improve patient health and bring positive change for California patients and their families.
Late last month, House Ways and Means Committee Chairman Richard Neal (D-Mass.) and Ranking Member Kevin Brady (R-Texas), and House Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) and Ranking Member Greg Walden (R-Ore.), released a discussion draft text of legislation proposing updates to reform and improve the Medicare Part D program. In coordination with our membership, CLSA submitted comments to Committee Leadership in support of the concept of a cap or limit on the amount that seniors pay out-of-pocket for prescription drugs in Part D.
In May 2019, the Securities and Exchange Commission (SEC) proposed a new rule to expand the universe of small public companies exempt from Sarbanes-Oxley (SOX) Section 404(b) to companies with annual revenues of less than $100 million. SOX 404(b) was established with the intent to protect investors against corporate fraud by increasing the quality of a company’s financial reporting via enhanced transparency and auditor oversight of internal control systems.
The PAHPAI Act is key to strengthening our country’s national preparedness and response efforts for public health emergencies and accelerating medical countermeasure research and development.
On Wednesday, May 8, 15 members of CLSA’s Board of Directors spent a full day on Capitol Hill meeting with nearly 20 key legislators and senior staff, on issues of importance to California’s biomedical innovation ecosystem.
On Thursday, May 16, CLSA’s advocacy paid off when CMS released its final rule and fact sheet. In the final rule, CMS decided to not adopt two proposals which would have allowed Part D plans to exclude a protected class drug from their formularies for multiple years if price-growth exceeded an inflation index as well as if the drug represented a new formulation that is not a significant innovation over the original product.