Is the FDA Driving Medical Innovation Offshore?
In its quest to reduce clinical risks to patients, the U.S. Food and Drug Administration may be crippling the drivers of life-saving medical innovation. New regulations are making it more difficult for companies to receive FDA approval for medications or medical devices, which could have a chilling effect on their development.
“The landscape in the U.S. is changing in terms of the ability of new medical devices to earn FDA approval,” said William O’Neill, executive dean for clinical affairs at the Miller School of Medicine during a panel discussion titled “Coping with a New Landscape of FDA Regulations: The Patient-Centric View.” The discussion was part the University of Miami Global Business Forum, which took place Jan. 12–14, 2011.
The U.S. has one of the world’s most risk-averse regulatory climates, O’Neill added. “As a result, U.S. patients are going out of the country for clinical use of new devices. Americans take pride in having the most sophisticated medical care on the planet, but that is really at risk right now. Venture capital is drying up, companies are shutting down, and the public is afraid of new devices, even though they might well extend their lives.”
Physician Richard S. Stack, managing general partner at the medical device developer Synecor, agreed, saying that the FDA’s desire to avoid risk is leading to longer product approval periods. Those delays increase development costs, add uncertainty to the application process and make medical product companies less attractive to investors.
“While the FDA is destroying innovation in the U.S. for American patients, other countries welcome our advanced technology,” he said.
Stack went on to say that though his team has developed a device that they believe could save hundreds of thousands of lives, after an investment of $80 million to date, another $150 million would be needed to bring it to the FDA. “Since venture capitalists can’t afford that much, we have no choice but to continue the work outside the U.S.,” he said.
Stack praised UM for recognizing the impact this has on patient care, and for building relationships with academic medical centers in Latin America. “With any new device or medication, there has to be a first group of patients,” he said. “We plan to work with the university and look at the ways Americans can access these new technologies outside the country.”
William A. Hawkins, CEO of the medical technology company Medtronic, noted that when the FDA took jurisdiction over medical devices back in the 1970s, it had two clear goals: to protect public health and to promote innovation for patients. “Now those goals are out of balance,” he said.
In the past two years, the number of approvals for new products has dropped substantially, from about 40 a year to 16, Hawkins said. And a stepped-up compliance program adds to manufacturers’ costs.
“I think we need a stronger FDA that works with companies to be sure that devices that go on the market are safe and effective,” Hawkins said. “We need to be sure they understand the unintended consequences of decisions to say no, and show them the data that make it easier for them to say yes. We also need an FDA that is more transparent and more consistent in its actions on the compliance side.”
O’Neill, a physician, also called for a robust FDA post-approval surveillance system to detect potential complications. “Some patient safety problems occur so infrequently they cannot be detected during clinical trials and approval process,” he said. “But almost any blockbuster drug used to treat millions of patients will likely have some type of complication.”
Jon R. Cohen, senior vice president and chief medical officer of Quest Diagnostics, noted that the FDA’s rules for diagnostic tests are designed to assure accuracy and reproducibility, rather than patient safety, so the approval process is typically shorter. In fact, Cohen, who is also a physician, applauded the FDA for its rapid approval of a diagnostic test for H1Nl influenza. “I am concerned, though, that more FDA regulation would reduce R&D spending for diagnostic tests and treatments,” he added.
Physician Thomas P. Stossel, director of the Translational Medicine Division at Brigham and Women’s Hospital at Harvard Medical School, called for the FDA to review its policies and look at the potential rewards of approving innovative medical devices.
“The agony of balancing risk and benefit has not changed in the FDA’s 100-year history,” Stossel said. “But it’s obvious that the willingness to take some risk on new medical products has paid off for U.S. patients.”
Pascal J. Goldschmidt, a physician and dean of the Miller School of Medicine, which organized the session, agreed. “Regulatory agencies may seek to limit risks, but the only way to avoid them is to do nothing at all,” he said. “We need a strong FDA that realizes there will be unpredictable complications from time to time.”
By Richard Westlund
