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Ophthalmic innovations affected by FDA, Patient Protection and Affordable Care Act
Leaders in ophthalmology discussed business and regulatory issues at the Ophthalmology Innovation Summit.
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CHICAGO — The re-election of President Barack Obama could affect future innovations in ophthalmology, and there is reason to be concerned, a speaker said here.
“American device makers and manufacturers are moving overseas, the country of origin provision is a problem, and U.S. FDA approval delays are causing increased disruptions as a result of the Patient Protection and Affordable Care Act,” Jim Mazzo, then president of Abbott Medical Optics, said at the Ophthalmology Innovation Summit. (Mazzo retired from AMO at the end of 2012.)
Mazzo said the act, signed into law by Obama in 2010, could present challenges for the ophthalmology industry.
Jim Mazzo
The Ophthalmology Innovation Summit, first developed in 2006 by Emmett T. Cunningham Jr., MD, PhD, MPH, debuted in 2009 preceding the American Academy of Ophthalmology meeting.
Cunningham, along with William Link, PhD, and Gilbert Kliman, MD, developed “a forum dedicated to advancing ophthalmic innovation by uniting the leading investors, physicians, entrepreneurs and corporate executives in the ophthalmology space to facilitate information transfer, deal-flow, and strategic partnerships and acquisitions,” according to the Ophthalmology Innovation Summit website.
FDA
According to Richard L. Lindstrom, MD, OSN Chief Medical Editor, the FDA is attempting to improve the current situation.
“Evidence is accumulating that the FDA is transitioning more toward being a part of the solution for constructive medical product innovation rather than the oft-perceived obstructionistic bad cop. If so, that will be great for medical product innovation in America,” Lindstrom told Ocular Surgery News at the summit.
Opportunity lies within significant unmet needs in ophthalmology, Lindstrom said.
“The bad news is that regulatory barriers are high and third-party payers are less and less inclined to pay for innovation,” he said. “The solution is more patient responsibility for the costs of new and innovative products and treatments. This is a global trend.”
Lindstrom also said a solution is needed for a more sustainable approach to new ophthalmic drug and technology approvals.
According to Wiley A. Chambers, MD, deputy director of the Division of Transplant and Ophthalmology Products in the Center for Drug Evaluation and Research at the FDA, communication is not necessarily the problem. The FDA will never turn down a drug product meeting with a physician or company; however, a solution still does not exist on how to speed up the FDA approval time.
“When applications are incomplete, is it better to refuse to file the application and send it back to the company until it is ready, or is it better to do a full review and provide the company with a list of full deficiencies several months later when the review is complete?” Chambers asked. “Which one is ultimately going to take the shortest approval time? We don’t have an answer to that.”
“It is interesting that only 8% of new drugs that enter FDA trials achieve approval at a cost that can approach a billion dollars,” Lindstrom said. “We all agree this is not sustainable. There is no current consensus on a solution. We need a solution, or really new drugs for major unmet needs will become history.” – by Ashley Biro