In the current regulatory environment, it's easier for Boston Scientific Corp. to introduce a product in Singapore or Europe than it is in the United States, says John Sheets, senior vice president of corporate research for the company.
Sheets' comment at the Cleveland Clinic's 2011 Medical Innovation Summit in early October echoed similar remarks made by other health care industry executives at the conference regarding the Food and Drug Administration. Several speakers at the summit said the rate of medical innovation in the United States has fallen behind global competitors as manufacturers and investors struggle to work through inefficient regulatory processes. "Unfortunately, our partners in the FDA tend to be running business looking in the rearview mirror; they're not out in front of us," Sheets told conference attendees on Oct. 4.
While most executives agreed the FDA plays an important role in consumer safety, they criticized the agency for long approval times that are shifting the introduction of new technologies to other countries. Japan used to be one of the last developed countries to approve a medical product -- now it ranks ahead of the United States, says Daniel Starks, CEO of St. Jude Medical Inc.
The FDA is underfunded and needs more resources, including people with technologically advanced knowledge who can better understand more sophisticated products, Starks says. Some industry leaders suggest the FDA should become more involved in fostering new technological advancements, including the creation of a chief innovation officer.
The FDA could help medical device and pharmaceutical manufacturers bring new treatments and technologies to market by improving its scientific capabilities and collaborating more with the industry, says John Castellani, CEO of Pharmaceutical Research and Manufacturers of America, or PhRMA. The time from initial drug development research to final approval by the FDA can take 10 to 15 years, he said at the conference.
The FDA has apparently been listening to some of the industry's concerns. On Oct. 5, the agency published a report called "Driving Biomedical Innovation: Initiatives to Improve Products for Patients." FDA Commissioner Margaret Hamburg identified seven major reforms in the report that the FDA plans to undertake.
This includes training for the next generation of innovators. The FDA plans to hire people who show outstanding promise in their fields to receive training in various industry disciplines, including design and development, manufacturing and regulatory affairs. The FDA also plans to develop a network of experts who will help the agency gain a better understanding of emerging technologies in fields where FDA reviewers might lack familiarity. Another area of focus for the FDA will be expedited drug development to speed up the clinical -- trial process.
If the FDA doesn't improve its approval times, the United States risks losing manufacturing to countries as close as Canada, said General Electric Co. CEO Jeffrey Immelt in a keynote address at the conference.
"If you can get a product approved for sale in Canada and it takes you three years to get it approved in the U.S., why would you stay here?" Immelt asked the Clinic audience.