The IRA is now law. What comes next?

AZBio President & CEO, Joan Koerber-Walker provides a brief overview of the provision of the Inflation Reduction act of 2022 (The IRA) from the patient and health innovation perspective and is then joined by health innovator and drug developer, Dr. Steven J. Potts, for a discussion of the potential unintended consequences of some provisions of The IRA relating to the future health innovation landscape.Continue reading

Industry Leaders Weigh In on the Inflation Reduction Act

On Sunday, August 7, 2022, the United States Senate passed the Inflation Reduction Act of 2022 in a party line vote with Vice President Kamala Harris casting the tie breaking vote.  The legislation now moves back to the House of Representatives.  Speaker Pelosi stated, “The House will return and move swiftly to send this bill to the President’s desk ….”

The 755 page legislation will continue to garner significant public debate and analysis in the coming days.

Continue reading

BIO Statement on CMS National Coverage Determination for Drugs Used to Treat Patients Suffering from Alzheimer’s Disease

On April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) released a national policy for coverage of aducanumab (brand name Aduhelm™) and any future monoclonal antibodies directed against amyloid approved by the FDA with an indication for use in treating Alzheimer’s disease. In its official statement, the Biotechnology Innovation Organization (BIO) shares why the CMS Decision is an enormous setback for Alzheimer’s patients and a dangerous infringement on FDA’s Scientific Autonomy.

 

Continue reading

Get Engaged In the SBIR STTR Reauthorization Discussion

The SBIR/STTR Programs are currently set to expire on September 30, 2022. It would be damaging to American innovation and competitiveness if these programs were to expire before a full reauthorization can be passed. The SBIR/STTR Programs enable small businesses to develop and commercialize new innovative technologies and have a proven track record of promoting competition through a merit-based application process.  Since their establishment in 1982, these programs have provided over 179,000 awards, totaling more than $54.3 billion, to U.S. small businesses. A study by the National Academy of Sciences found a commercialization rate of 50-60% for SBIR/STTR investments. You can see the impact of SBIR/STTR in Arizona by clicking here.  

Continue reading

HB2039 Health; Innovation; Trust Fund

On March 29, 2022, Arizona’s  Senate Appropriations Committee voted unanimously to give a Do Pass as Amended recommendation for HB2039.  The next step in the process is review by the Senate Rules Committee.

If HB2039 successfully completes the legislative process and is signed into law by the Governor, it will establish the statutory framework for the Arizona Health Innovation Trust Fund within the Arizona State Treasurer’s Office with the State Treasurer as Trustee. Continue reading

Nearly 100 Organizations and Experts Urge HHS Secretary Xavier Becerra to Reject Xtandi March-In Petition

WASHINGTON, D.C. (March 17) — In a letter transmitted today, the Bayh-Dole Coalition and nearly 100 prominent academic and private sector innovation experts and organizations, public policy associations, and legal scholars urged U.S. Department of Health and Human Services Secretary Xavier Becerra to reject the latest march-in petition on prostate cancer drug Xtandi.Continue reading

What Drives the Creation and Delivery of Cures and What Doesn’t

AZBio President & CEO, Joan Koerber-Walker,  shared insights with Duane Schulthess, Managing Director of Vital Transformation on the the Vital Health Podcast.  The popular podcast series has a global reach and features relaxed, one on one discussion with health care professionals, researchers, and regulators. Topics explore the implications of new medical procedures, technologies and policies as well as  their impact on current clinical practices.

Continue reading

Life Science Leaders Weigh In On Build Back Better Provisions

On Friday, November 19, 2021, the U.S. House of Representatives passed the Build Back Better bill on a 220-213 vote.  The bill now moves to the Senate for further review and action. Valued at close to $2 trillion, the bill includes  a potpourri of  Democratic social spending priorities that includes free preschool for 3 and 4 year old children, initiatives to fight climate change and affordable housing programs. The bill also includes increases to  Pell grants for college tuition, expands family leave, and provides new hearing benefit for seniors.   It also incudes “pay fors” including   increases corporate taxes, funds additional resources for IRS enforcement, AND implements price controls on certain medicines.  Investors and life science companies of all sizes have expressed serious concerns that if the latter provisions pass the Senate and are implemented the impact on future health innovation could be devastating. Continue reading