MedTech Communicates Bio/Med Industry Priorities to Federal Legislators
Thursday, February 27, 2014
MedTech Association, a trade association for New York’s bioscience and medical technology (Bio/Med) industry, today is meeting with federal legislators in Washington to discuss mandates affecting the Bio/Med industry at a national level, in one prong of a concentrated effort to alleviate obstacles to growth in the industry.
MedTech has identified key areas where its members face consistent challenges in regard to growing their businesses. Streamlined regulatory processes and access to capital for R&D, through the Food and Drug Administration (FDA) and National Institute of Health (NIH), respectively, are two very real issues that must be addressed for the United States to remain competitive in the global Bio/Med marketplace.
“Access to user fees and full funding for the FDA would help ensure timely FDA review of new products and help increase consultation between the FDA and the industry. This is crucial for the country’s economic and labor development,” said Jessica Crawford, president of MedTech. “Although there will not be sequestration cuts for FY14/15, going forward into FY16 and beyond, additional user fees are at risk. This situation requires a permanent fix.”
The United States is the foremost leader in developing novel medicines and treatments for patients suffering from untreated and under-treated diseases, in part as a result of the extensive scientific partnership between the publicly-funded biomedical research enterprise centered at the NIH and the life sciences community. In New York, the NIH provides the largest source of funding for basic research within our university system. As the cost of the drug development process continues to increase, the funding for this research through the NIH remains stagnant at best, subsequently leading to a lag between research and product development. This presents an obvious challenge to growth for those institutions seeking funding for life-saving R&D projects.
Another issue that the U.S. must address to allow for growth in the industry is repealing the 2.3% tax on medical devices As a result of the medical device tax, we have seen an unprecedented impact, including a job loss of 165,000 and 30.6% reductions in R&D. Additionally, 10% of our Bio/Med industry has taken steps to relocate manufacturing outside of the U.S. or expand manufacturing abroad.
The federal priorities set forth by MedTech – if adopted – represent a footprint to move the nation’s Bio/Med industry forward, and are as follows:
A. Food and Drug Administration
- Implement Full Funding of the FDA (permanently exempt user fees from sequestration);
- Work to Identify a Biosimilars Approval Pathway;
B. National Institutes of Health (NIH)
- Provide Full Funding for the NIH;
C. Federal Health Care
- Repeal Cuts to Medicare Part D and Medicare Part B;
- Repeal the Independent Payment Advisory Board (IPAB)
?D. Medical Device Tax
- Repeal the Medical Device Excise Tax;
E. Access to Capital
- Update Diagnostic Payment Reform; and
- Stimulate R&D Investment at Small Companies Through the Startup Jobs and Innovation Act.
MedTech is an active New York State association of pharmaceutical, biotech, and medical technology companies, their suppliers and service providers, and research universities. We boost the growth and prosperity of our members by connecting them for collaboration, offering educational programs, sharing news and information, and advocating for the industry with government and leaders. MedTech is celebrating its 10th year of connecting New York State's Bio/Med industry. For more information, visithttp://www.medtech.org. Like MedTech on Facebook and follow MedTech onTwitter.