A Legislative Voice
As both Minnesota's and the nation's largest state-based life science advocacy organization, LifeScience Alley delivers to members an aggressive and effective solutions-based public policy advocacy strategy in St. Paul and Washington, D.C. We develop and support policies that promote our industries' growth locally, nationally, and globally.
Below is a sampling of some of the issues we track representing a significant impact on our community and member organizations.
Rising costs in the healthcare marketplace have placed great importance on innovative products and therapies that not only enhance and save lives but decrease costs. While navigating the regulatory environment still presents challenges, the ability to create a therapy with the right value equation of improved outcomes and cost savings is critical to gaining health care coverage. LifeScience Alley is committed to finding opportunities to improve patient access to truly novel medical technologies by working with key stakeholders in the healthcare system.
Investments made by the National Institutes of Health (NIH) and life science industry in basic research have allowed for the creation of many of today's medical discoveries and scientific innovations. NIH funding has played a significant role in supporting the development of new therapies and treatments in diabetes and other critical areas. Currently 9 out of 10 NIH grant applicants are not funded. LifeScience Alley is committed to advocating for increased NIH funding to encourage investment in innovation.
Tax Policies - Medical Device Tax
The medical device tax places a 2.3% excise tax on the sales of taxable medical devices. There is broad bipartisan support to repeal the device tax which burdens small companies and stifles company growth, job creation, and medical progress. Given the size and strength of Minnesota's medical device industry, the device tax represents a serious threat to a critical component of our economy, and the U.S. economy as a whole. Minnesota's federal delegates are active supporters of tax repeal efforts and continue to lead a bipartisan dialogue on the impact of this onerous tax.
Tax Policies - Tax Reform
In order to create an environment supportive of new company creation and growth, national corporate tax policy must undergo comprehensive reform. Bipartisan support underscores that reform is essential to improving U.S. competitiveness and securing future economic growth.
Regulatory Affairs - 510(k)
Balancing the needs of innovation and regulation affects the entire medical device market. The FDA's 510(k) pre-market review process provides the flexibility to ensure the safety and efficacy of low to moderate-risk medical devices based on historical understanding gained from similar devices. The 510(k) review process is designed to allow the FDA to review a wide range of products in a timely fashion that allows for the availability of safe, life-saving products for patients.
Regulatory Affairs - Medical Device User Fee Agreement
The Medical Device User Fee and Modernization Act (MDUFMA) gave the FDA the authority to collect user fees from medical device sponsors for review activities. MDUFMA also allows the FDA to enact needed regulatory reforms. The most recent reauthorization of MDUFMA and renegotiation of industry user fees constitutes a substantial increase in fees to FDA, allowing for enhanced performance goals from FDA and additional resources to improve the predictability of regulatory processes.