Challenges in Ophthalmology with April Steinert

Outgoing ASCRS executive director challenged by overregulation in ophthalmology

David Karcher explains how government restrictions have created frustrations for ASCRS members.

I cannot hear or see the acronym ASCRS without conjuring up an image of David Karcher in my head. As executive director of the American Society of Cataract and Refractive Surgery, David has stood at the helm and navigated many turbulent regulatory seas in the field of ophthalmology for more than 37 years. His commitment to the society, along with his tenacious drive, have made ASCRS the outstanding organization it is today.

David will formally retire effective Dec. 31, 2018, and has begun to pass the baton to Stephen H. Speares, the new ASCRS executive director, so David was able to find some time to chat with me about what he considers his most significant challenge as executive director, as well as for ASCRS as an organization.

David’s biggest challenge as the ASCRS executive director has been the burden of overregulation and the inherent restrictions it places on ASCRS members and their practices. He explained that government regulation coupled with insurance companies “practicing medicine” has created a frustrating scenario for ASCRS members; moreover, Congress shifted its lawmaking responsibilities to agencies to write laws without the usual checks and balances necessary to develop an efficient and fair system for all. David pointed out that there are plenty of laws in place already, and we should be making examples of the bad apples rather than adding more regulations and excess paperwork.

In the early ’80s, David’s indoctrination into the world of overregulation came in the form of intense scrutiny of IOLs by the FDA. Those studies were the largest ever conducted and created a tremendous backlog of IOLs waiting for approval. And then in the mid-80s, Medicare reimbursement for IOLs became an issue. While reimbursement and the FDA approval process for new technologies are not quite as burdensome as they once were during the early IOL days, when you look outside the United States at other approval processes and make comparisons, the U.S. is still severely lagging. There are IOLs implanted today in Europe that we do not have access to in this country, for example. The reluctance of the FDA to accept available data from studies done outside of the U.S. adds to the frustration of those ophthalmologists who want to be on the cutting edge. As a result, ophthalmic companies focus on international ophthalmologists to assist them with their studies to propel their products to market faster than would occur in the U.S.

David also pointed out that as a citizen of the most advanced country in the world, where many of these technologies emerge, we should have access to them before the international ophthalmic community.

The FDA recently announced that there would be a reorganization of the Office of New Drugs in the Center for Drug Evaluation and Research that will increase the number of review offices from five to nine and the number of review divisions from 19 to 30. With this proposed reorganization, ophthalmology would have its own drug division, subject to review by the Department of Health and Human Services, the Office of Management and Budget, and Congress. The FDA’s proposal of a dedicated ophthalmic drug division is in direct response to ASCRS advocacy, and David said, “If ophthalmology did not have representatives from ASCRS and AAO in D.C. at the table advocating for less burdensome overregulation, things would be much worse than they are today.”

David’s contributions to ophthalmology have been prodigious and everlasting. ASCRS would not be where it is today without him.

In closing, it behooves everyone to become more involved by joining eyePAC (www.ascrs.org/legislative-and-regulatory/category/eyepac) to engage in the nonpartisan political process and know that you are making a difference.

“Do what you can, with what you have, where you are.” – Teddy Roosevelt

Disclosure: Steinert reports no relevant financial disclosures.

I cannot hear or see the acronym ASCRS without conjuring up an image of David Karcher in my head. As executive director of the American Society of Cataract and Refractive Surgery, David has stood at the helm and navigated many turbulent regulatory seas in the field of ophthalmology for more than 37 years. His commitment to the society, along with his tenacious drive, have made ASCRS the outstanding organization it is today.

David will formally retire effective Dec. 31, 2018, and has begun to pass the baton to Stephen H. Speares, the new ASCRS executive director, so David was able to find some time to chat with me about what he considers his most significant challenge as executive director, as well as for ASCRS as an organization.

David’s biggest challenge as the ASCRS executive director has been the burden of overregulation and the inherent restrictions it places on ASCRS members and their practices. He explained that government regulation coupled with insurance companies “practicing medicine” has created a frustrating scenario for ASCRS members; moreover, Congress shifted its lawmaking responsibilities to agencies to write laws without the usual checks and balances necessary to develop an efficient and fair system for all. David pointed out that there are plenty of laws in place already, and we should be making examples of the bad apples rather than adding more regulations and excess paperwork.

In the early ’80s, David’s indoctrination into the world of overregulation came in the form of intense scrutiny of IOLs by the FDA. Those studies were the largest ever conducted and created a tremendous backlog of IOLs waiting for approval. And then in the mid-80s, Medicare reimbursement for IOLs became an issue. While reimbursement and the FDA approval process for new technologies are not quite as burdensome as they once were during the early IOL days, when you look outside the United States at other approval processes and make comparisons, the U.S. is still severely lagging. There are IOLs implanted today in Europe that we do not have access to in this country, for example. The reluctance of the FDA to accept available data from studies done outside of the U.S. adds to the frustration of those ophthalmologists who want to be on the cutting edge. As a result, ophthalmic companies focus on international ophthalmologists to assist them with their studies to propel their products to market faster than would occur in the U.S.

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David also pointed out that as a citizen of the most advanced country in the world, where many of these technologies emerge, we should have access to them before the international ophthalmic community.

The FDA recently announced that there would be a reorganization of the Office of New Drugs in the Center for Drug Evaluation and Research that will increase the number of review offices from five to nine and the number of review divisions from 19 to 30. With this proposed reorganization, ophthalmology would have its own drug division, subject to review by the Department of Health and Human Services, the Office of Management and Budget, and Congress. The FDA’s proposal of a dedicated ophthalmic drug division is in direct response to ASCRS advocacy, and David said, “If ophthalmology did not have representatives from ASCRS and AAO in D.C. at the table advocating for less burdensome overregulation, things would be much worse than they are today.”

David’s contributions to ophthalmology have been prodigious and everlasting. ASCRS would not be where it is today without him.

In closing, it behooves everyone to become more involved by joining eyePAC (www.ascrs.org/legislative-and-regulatory/category/eyepac) to engage in the nonpartisan political process and know that you are making a difference.

“Do what you can, with what you have, where you are.” – Teddy Roosevelt

Disclosure: Steinert reports no relevant financial disclosures.