It’s a refrain that is becoming familiar in the medical device industry: over-regulation is strangling innovation. Recently, however, this particular topic isn’t being championed by special interest groups representing medical device companies, but rather by a growing number of concerned outsiders from the venture capital industry who are becoming increasingly convinced that FDA regulations are beginning to choke back the rate of technological progress in the United States.
According to The New York Times, $3.3 million in political donations have been made by financial funds associated with medical device investment to both Democrat and Republican candidates and committees since 2006. The Times further clarified that 20 percent of these funds were specifically earmarked for initiatives aimed at reducing the amount of FDA red tape required to bring a new product to market. The latest embodiment of this sentiment has been the support thrown behind Representative Erik Paulsen of Minnesota, who is sponsoring legislation that would further streamline FDA approval of innovative medical devices.
This blog has covered the efforts of Representative Paulsen and other members of Congress in the past. Information concerning the increased attention being paid by the investment community to the medical device approval process is new and indicates that the FDA could be facing a multi-pronged offensive on the part of companies, financial institutions, and practitioners who want easier access to potentially revolutionary medical technologies. Both the Senate and the House of Representatives have seen an increase in the number of bills introduced that are aimed specifically at accelerating FDA approval of medical devices, while the number of public hearings concerning the same regulatory procedures also continues to grow.
Protecting public health remains the number one concern at the FDA, but the Administration is also actively seeking to do what it can to balance the need to approve advanced, cost-saving treatments and devices with its duty to keep Americans safe from the harm that could be caused by inadequately tested products. There is also the question of whether the interests of venture capitalists have taken into account the broader scope of the medical device safety issue, given that typical investment strategies involve cashing out after a product has initially hit the market. One thing is certain: with so much dialogue sparked concerning FDA regulatory and approval practices, the current atmosphere in Washington could be more primed than ever for an evolutionary step forward in medical device regulations.
adapted and republished with permission from MDCI