Ophthalmology community reacts to Gottlieb’s resignation

Scott Gottlieb

FDA Commissioner Scott Gottlieb, MD, announced he will step down from his position early next month, leaving a 2-year tenure as head of the agency.

HHS Secretary Alex Azar lauded Gottlieb’s leadership of the FDA, including his perseverance in curbing youth tobacco and e-cigarette use and his tenacity to move treatment and generic drug approvals through the process efficiently.

“The public health of our country is better off for the work Scott and the entire FDA team have done over the last 2 years,” Azar said in a press release.

Gottlieb tweeted a response thanking Azar and President Donald Trump, saying he was “immensely grateful for the opportunity to help lead this wonderful agency.”

“This has been a wonderful journey and parting is very hard,” he wrote.

Healio.com/OSN spoke with some ophthalmology leaders who shared their opinions on Gottlieb’s tenure and what they would like to see in the future as the FDA moves on.

 

Michael X. Repka

Michael X. Repka, MD

Medical Director for Government Affairs , American Academy of Ophthalmology

The Academy appreciates the hard work that Commissioner Gottlieb put in during his tenure at FDA. His tenure included significant achievements for ophthalmology, including permitting marketing for the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy. The Academy supported his efforts to promote competition in the pharmaceutical marketplace through accelerated approvals for generic medications. We were pleased that in 2018 he moved additional FDA resources into responding to the growing challenge of drug shortages, which are having a significant impact on ophthalmology.

The Academy hopes that the new commissioner will continue to advance innovation for our specialty, and all of medicine, while addressing the growing drug shortage crisis in ophthalmic medications and ensuring access to vital treatments for our patients.

 

Pravin U. Dugel

Pravin U. Dugel, MD

OSN Retina/Vitreous Board Member

The purpose of the FDA is first and foremost to ensure safety for patients in clinical trials and the safety of the final product if it should become approved. In that regard, people can certainly point to certain times in history where that might not have happened, but in general I think the FDA has been a remarkably effective organization. I think it has been one of the shining stars historically of our government system. Sometimes the needle has pointed in different directions, and before Dr. Gottlieb’s tenure, one could argue the needle was such that the FDA may have been a little bit slower to get drugs and devices approved. I think what Dr. Gottlieb has done is to put that needle a little more toward the other side in ensuring that, while protecting patient safety, drugs and devices are approved in a more effective manner. He has done that by working more closely with industry. The lessons to be learned from his tenure is that the FDA system is most effective when there is constructive dialogue between government regulatory affairs and industry for the benefit of the patient. That is the triangulation here, and I think he has managed that with skill and compassion.

In that spirit, I hope many of the things Dr. Gottlieb has emphasized will also be championed by the new commissioner. I specifically note gene therapy. Dr. Gottlieb has recognized that this is the next dimension of health care, and he has been adamant about pushing these technologies forward in a responsible way, and I hope that the next commissioner will continue upon that progress.

 

Kuldev Singh

Kuldev Singh, MD, MPH

Stanford University, Palo Alto, California

From my standpoint as a practicing ophthalmologist, Dr. Gottlieb had a successful tenure as FDA commissioner for many reasons, the most important of which is that he gave the directors of the two centers that are most relevant to our profession, the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), autonomy to lead their teams. Drs. Janet Woodcock and Jeffrey Shuren at CDER and CDRH, respectively, along with Dr. Peter Marks at the Center for Biologics Evaluation and Research (CBER), rolled out several successful initiatives under Dr. Gottlieb’s term that had, without exception, a positive impact on ophthalmology. Dr. Woodcock’s support for ophthalmic decisions being made by ophthalmologists and Dr. Shuren’s commitment to artificial intelligence, with ophthalmology leading the way, were particularly noteworthy.

Dr. Gottlieb’s background in both the private and public sectors served him well in understanding the potential barriers faced by innovators in health care. He benefited from the strong work of his predecessor, Dr. Robert Califf, who, despite a short tenure, did much to improve the infrastructure at the FDA. Dr. Gottlieb continued the positive momentum created by Dr. Califf in supporting FDA processes that were less bureaucratic and thus allowed for safe and effective products to be assessed and approved more efficiently than in the past. The emphasis in making the U.S. a leader rather than a late follower in regulatory science was palpable during both of their terms. It is difficult to recall two successive commissioners who had a more positive impact on the culture of the FDA than Drs. Califf and Gottlieb.

The void left by Dr. Gottlieb’s departure will be difficult to fill. Hopefully the next commissioner will be someone who appreciates the unique regulatory nuances related to ocular health. Given that ours is a surgical as well as medical field, an understanding of device innovation is much appreciated by the ophthalmology community.

– by Rebecca L. Forand

 

Disclosures: Repka, Dugel and Singh report no relevant financial disclosures.

Scott Gottlieb

FDA Commissioner Scott Gottlieb, MD, announced he will step down from his position early next month, leaving a 2-year tenure as head of the agency.

HHS Secretary Alex Azar lauded Gottlieb’s leadership of the FDA, including his perseverance in curbing youth tobacco and e-cigarette use and his tenacity to move treatment and generic drug approvals through the process efficiently.

“The public health of our country is better off for the work Scott and the entire FDA team have done over the last 2 years,” Azar said in a press release.

Gottlieb tweeted a response thanking Azar and President Donald Trump, saying he was “immensely grateful for the opportunity to help lead this wonderful agency.”

“This has been a wonderful journey and parting is very hard,” he wrote.

Healio.com/OSN spoke with some ophthalmology leaders who shared their opinions on Gottlieb’s tenure and what they would like to see in the future as the FDA moves on.

 

Michael X. Repka

Michael X. Repka, MD

Medical Director for Government Affairs , American Academy of Ophthalmology

The Academy appreciates the hard work that Commissioner Gottlieb put in during his tenure at FDA. His tenure included significant achievements for ophthalmology, including permitting marketing for the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy. The Academy supported his efforts to promote competition in the pharmaceutical marketplace through accelerated approvals for generic medications. We were pleased that in 2018 he moved additional FDA resources into responding to the growing challenge of drug shortages, which are having a significant impact on ophthalmology.

The Academy hopes that the new commissioner will continue to advance innovation for our specialty, and all of medicine, while addressing the growing drug shortage crisis in ophthalmic medications and ensuring access to vital treatments for our patients.

 

Pravin U. Dugel

Pravin U. Dugel, MD

OSN Retina/Vitreous Board Member

The purpose of the FDA is first and foremost to ensure safety for patients in clinical trials and the safety of the final product if it should become approved. In that regard, people can certainly point to certain times in history where that might not have happened, but in general I think the FDA has been a remarkably effective organization. I think it has been one of the shining stars historically of our government system. Sometimes the needle has pointed in different directions, and before Dr. Gottlieb’s tenure, one could argue the needle was such that the FDA may have been a little bit slower to get drugs and devices approved. I think what Dr. Gottlieb has done is to put that needle a little more toward the other side in ensuring that, while protecting patient safety, drugs and devices are approved in a more effective manner. He has done that by working more closely with industry. The lessons to be learned from his tenure is that the FDA system is most effective when there is constructive dialogue between government regulatory affairs and industry for the benefit of the patient. That is the triangulation here, and I think he has managed that with skill and compassion.

In that spirit, I hope many of the things Dr. Gottlieb has emphasized will also be championed by the new commissioner. I specifically note gene therapy. Dr. Gottlieb has recognized that this is the next dimension of health care, and he has been adamant about pushing these technologies forward in a responsible way, and I hope that the next commissioner will continue upon that progress.

 

Kuldev Singh

Kuldev Singh, MD, MPH

Stanford University, Palo Alto, California

From my standpoint as a practicing ophthalmologist, Dr. Gottlieb had a successful tenure as FDA commissioner for many reasons, the most important of which is that he gave the directors of the two centers that are most relevant to our profession, the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), autonomy to lead their teams. Drs. Janet Woodcock and Jeffrey Shuren at CDER and CDRH, respectively, along with Dr. Peter Marks at the Center for Biologics Evaluation and Research (CBER), rolled out several successful initiatives under Dr. Gottlieb’s term that had, without exception, a positive impact on ophthalmology. Dr. Woodcock’s support for ophthalmic decisions being made by ophthalmologists and Dr. Shuren’s commitment to artificial intelligence, with ophthalmology leading the way, were particularly noteworthy.

Dr. Gottlieb’s background in both the private and public sectors served him well in understanding the potential barriers faced by innovators in health care. He benefited from the strong work of his predecessor, Dr. Robert Califf, who, despite a short tenure, did much to improve the infrastructure at the FDA. Dr. Gottlieb continued the positive momentum created by Dr. Califf in supporting FDA processes that were less bureaucratic and thus allowed for safe and effective products to be assessed and approved more efficiently than in the past. The emphasis in making the U.S. a leader rather than a late follower in regulatory science was palpable during both of their terms. It is difficult to recall two successive commissioners who had a more positive impact on the culture of the FDA than Drs. Califf and Gottlieb.

The void left by Dr. Gottlieb’s departure will be difficult to fill. Hopefully the next commissioner will be someone who appreciates the unique regulatory nuances related to ocular health. Given that ours is a surgical as well as medical field, an understanding of device innovation is much appreciated by the ophthalmology community.

– by Rebecca L. Forand

 

Disclosures: Repka, Dugel and Singh report no relevant financial disclosures.