By: Jordan Kinghorn

The Committee on Energy and Commerce’s subcommittee on health had a field hearing today, September 26, in La Jolla, CA on the impact the FDA’s inconsistent, unpredictable, and obscure regulations are having on the medical device and drug industry. It is a major problem when project submission to the FDA is lengthy, unreasonable, and unpredictable. Clarity by the FDA on what is needed to approve a product is essential to the medical device industry.  In accordance with basic free-market principles, the more the federal government regulates, the higher the costs for a business to create new and innovative products and the lower the incentive for venture capitalists to invest due to the uncertainty that comes with navigating red tape.

As the witnesses at the hearing today testified, the new FDA regulations, in combination with the 2.3% excise tax on all new medical devices in the PPACA, have led to the off-shoring of medical device companies and have brought U.S. medical innovation to a halt. Medical device companies in the U.S. have had significantly fewer projects and some like NuVasive have reduced hiring by 15%. Global competitors are stream lining regulatory systems, thus drawing business to their shores. The U.S. must have laws and regulations that protect our innovative edge, not the other way around.

Why would congressional leaders target an industry that is so fruitful and produces 2 million high wage jobs and 26 billion in revenue? The medical device industry provides innovative products that lower the cost of health care while improving patient safety and well-being; the main goal of healthcare reform. Ultimately, the regulations and taxes of the FDA and PPACA are stifling the economy and harming patients; doing exactly the opposite of what they claim to accomplish.