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Increasing regulatory barriers may threaten US medical innovation
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 Richard L. Lindstrom |
SAN DIEGO — Mounting U.S. Food and Drug Administration regulations imposed on new medical technologies may jeopardize the standards of care in the United States, according to a presenter here.
"Regulatory barriers are potentially undermining our ability to innovate and to teach others about innovation," Richard L. Lindstrom, MD, OSN Chief Medical Editor, told OCULAR SURGERY NEWS after accepting his award at the 2011 Charles D. Kelman Innovator's Lecture.
"I believe the duty of the ophthalmologist is greater than simply being an eye care provider," he said in the lecture, held during the American Society of Cataract and Refractive Surgery meeting.
Dr. Lindstrom told colleagues that defining problems and unmet needs that may help preserve, restore and enhance vision is a crucial ophthalmic duty, one that involves collaborating with government and industry officials and disseminating knowledge acquired through clinical practice and innovation.
"Regulation and compliance are threatening our ability to be able to take care of our patients in a compassionate and appropriate fashion," he said.
According to Dr. Lindstrom, 80% of the time and money spent developing a new medical technology is dedicated to pushing it through the FDA approval process.
He emphasized that, while unavoidable, conflicts of financial interest can be mitigated or managed. He said that his personal motto is to prioritize his patients first, and when conflicts arise, complete disclosure is crucial in order to maintain trust.
"Do not fear transparency; it is not going to put you at risk," Dr. Lindstrom said, referencing the Sunshine Act.
In select cases, he believes that recusal is appropriate but generally agrees with Harvard University's policy, which acknowledges the need for managed industry as a crucial funding resource.
According to Dr. Lindstrom, many companies become frustrated with delays in the FDA's approval process as well as subsequent monetary losses and opt to go overseas, where technologies are often available first.
"From the perspective of med-tech companies innovating new medical technologies in the U.S., the FDA substantially lags behind Europe in several performance indices," he said.
Dr. Lindstrom urged the audience to take a proactive stance and to approach legislators about this crucial issue.
"I believe increasing regulatory burdens and the rapidly rising cost in both resources and time to bring a drug to market is threatening the innovation cycle. This is a potentially serious threat to the well-being of our patients, our profession and America," he said.
Dr. Lindstrom said he was honored to receive this award.
"This is my favorite society, and this is one of the two major awards in this society," he said. "I have always been a lifetime innovator, so this one is especially special — looking at the other ones that I have gotten, number one. Number two, the fact that Charlie Kelman's name is on it also makes this even more special."
- Disclosure: Dr. Lindstrom provides practice management or marketing consulting services to 3D Vision Systems, Abbott Medical Optics, AcuFocus, Adoptics, Advanced Refractive Technologies, Alcon Laboratories, Aquesys, Bausch + Lomb, Biosyntrix, Bradley Scott Inc., Calhoun Vision, Clarity Ophthalmics, Clear Sight, Glaukos Corporation, High Performance Optics, Hoya Surgical Optics, LenSx, Ocular Surgery News/SLACK Incorporated, TearLabs Inc. and TLC Vision Corporation.