October 2018

NEWS & OPINION

FDA announces plan to create separate ophthalmology drug division as part of efforts to modernize CDER


by Ellen Stodola EyeWorld Senior Staff Writer/Digital Editor


Dr. Singh (left) with Dr. Woodcock
Source: Kuldev Singh, MD



“It is critical to have optimally functioning ophthalmology
processes at CDER, and I am confident that this is a priority for Dr. Woodcock and her team.”
—Kuldev Singh, MD

 

In June, the FDA announced a series of steps by the Center for Drug Evaluation and Research (CDER) to help modernize the organization and functions of the Office of New Drugs (OND). As part of this modernization, led by Janet Woodcock, MD, director of CDER, one aspect, as noted in a press release from the FDA, would be the possible creation of new therapeutic-specific divisions that will have more ability to engage in discrete areas of medicine. “The goal is to make sure that the drug review divisions are therapeutically focused to promote efficient review and provide greater scientific leadership to academic, industry and patient groups,” according to the press release. FDA Commissioner Scott Gottlieb, MD, also referenced these efforts in a press release in late August, where he specifically discussed modernizing the organization and breaking down outdated silos. His press release added that “the goal is to enable FDA review teams to be more disease focused, more integrated across the disciplines involved in drug review, and better able to evaluate and analyze data from agile clinical trials through a more structured approach to data review.” The structural changes will also be a part of the changes to the organization and function of the OND.
Part of this modernization includes the creation of a drug division specifically for ophthalmology. This change stems from advocacy efforts from ASCRS and other organizations to point out why a separate drug division is needed for ophthalmology. Following efforts from ASCRS, its FDA Committee, and ophthalmologists, including sending a letter from the ophthalmic organizations to Dr. Woodcock, the FDA made the decision to separate ophthalmology from the transplant division and have it temporarily function as its own department out of the OND at CDER. This is part of the overall reorganization of the OND and expanding the number of review divisions.
“This decision by the FDA should be welcome news for everyone in ophthalmology and for our patients,” said David Chang, MD, Los Altos, California. “Because a non-ophthalmologist from the transplant division previously had oversight over the approval of ophthalmic drugs, concerns were raised by a number of sponsors about the appropriateness of some of the testing required.” Because of the large number of new drug submissions in ophthalmology, this is a significant structural reform that should hopefully streamline the process of FDA approval, he said. “This was a priority for ASCRS, and we appreciate the willingness of the FDA to meet and to respond to our concerns.”
Kuldev Singh, MD, Palo Alto, California, weighed in on the efforts of ASCRS on this issue. Dr. Singh was involved on several levels and played a role in sending the letter to Dr. Woodcock as well as meeting with her and other FDA leaders to discuss the issue.
As an ophthalmologist who advises various stakeholders in the advancement of eye care, Dr. Singh expressed an interest in identifying and removing obstacles that may prevent safe and effective products from being available to patients in a timely manner. In his various roles, Dr. Singh has seen first-hand how efficiency in regulatory processes can influence innovation and investment in a particular discipline. Investors in healthcare have a choice regarding where to invest and generally direct funds toward fields where the regulatory process works in supporting the products that improve patient health. “As an ophthalmologist, I want to make sure that we have the absolute best eye regulatory processes, to give investors the confidence to support innovation, and for innovators to have faith that they will receive timely guidance and fair review from regulators to get the products that are safe and effective to the finish line,” Dr. Singh said.
On the pharma side represented by the CDER, Dr. Singh noted that for many years, ophthalmology did not have its own separate division, and, most importantly, the ultimate decision makers in ruling on decisions relating to ophthalmology products were not ophthalmologists. This was despite the fact that an overwhelming majority of product submissions to the combined transplant/ophthalmology division were for ophthalmic products. “Could you imagine how disturbed the cardiology community would be, for example, if decisions on whether or not to approve the next generation of drugs for heart disease were being made by an ophthalmologist? The structure simply did not make sense,” Dr. Singh said.
ASCRS took the lead in bringing this issue to the FDA’s attention. Along with the American Academy of Ophthalmology (AAO) and National Alliance for Eye and Vision Research (NAEVR), they met with Dr. Woodcock to advocate for an ophthalmologist to lead the ophthalmic review process.
ASCRS also led efforts to send a letter to Dr. Woodcock to further advocate on this issue and gave specific examples of instances where ophthalmologists were overruled on the decisions within the division. The letter was sent from Dr. Singh, Michael Repka, MD, and James Jorkasky on behalf of ASCRS, AAO, and NAEVR in December 2017.
After the meeting with Dr. Woodcock and receiving the letter, the FDA made the decisions to separate ophthalmology from the transplant divisions and have it temporarily function as its own department out of the OND at CDER. Dr. Singh said that he had further communication with Dr. Woodcock following the initial meeting, and in June, the FDA issued a press release saying that it would be restructuring, and ophthalmology would have its own division. This restructuring is still pending approval by Health and Human Services (HHS), the White House Office of Management and Budget (OMB), and Congress, but if approved, ophthalmology will function as its own division. This approval process could take more than a year.
Dr. Singh said this is a significant development and is a direct response to advocacy from ASCRS led efforts. “Not only did we help our own profession but might have helped the FDA more broadly in bringing some of these issues to their attention,” he said. “It is critical to have optimally functioning ophthalmology processes at CDER, and I am confident that this is a priority for Dr. Woodcock and her team,” he concluded.

Contact information

Chang
: dceye@earthlink.net
Singh: kuldev.singh@stanford.edu

FDA announces plan to create separate ophthalmology drug division as part of efforts to modernize CDER FDA announces plan to create separate ophthalmology drug division as part of efforts to modernize CDER
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