In recent years, it seems the FDA approval process has slowed down in the ophthalmic drug and device industries. Is the FDA stifling innovation, or are more stringent standards necessary for patient protection?

Motivation needed to bring products to market

R. Doyle Stulting

Today, the pathway to drug and device approval in the United States is long, arduous and expensive. As a result, we often find ourselves a decade behind the rest of the world in providing new technologies to our patients, especially when the intellectual property associated with a product will not clearly provide the profit to cover the high cost of an FDA submission.

Over the 20 years during which I have been involved with the FDA approval process for devices, I have seen a distinct reduction in the number of new product applications that have been approved. This is especially the case for novel products that represent significant advances or treatment of conditions that do not have a current treatment. FDA staff is highly motivated to avoid approval of drugs and devices that might have some potential adverse effects, but there is little motivation to move products through the system when they offer a new treatment option.

When I began my career as an ophthalmologist, the U.S. was the leader in medical care, and people came here to learn what was going on. I used products to the best of my ability, consistent with the scientific evidence that was available to me. Today, I must travel overseas, mainly to Europe and South America, to acquaint myself with new technologies, and there is a never-ending discussion about what can and cannot be said about “off-label uses.” I have even referred patients overseas for treatments I cannot legally provide to them in the U.S.

It is time for the pendulum to swing back, so that approval of new products is facilitated when the balance of scientific evidence from all sources supports that action. Regulators in the FDA need to be motivated to bring good products to market quickly, not just to avoid approving ones with potential complications.

We need to regain our leadership in innovation so that we can offer our patients new, effective technologies that are available elsewhere in the world. It is time to clarify the fact that the label does not necessarily reflect all appropriate uses of drugs and devices. And it is time to open up lines of communication between medical professionals to maximize patient care, based on real science.

Although I support transparency in disclosure of financial interests, we cannot let them prevent the exchange of information.

R. Doyle Stulting, MD, PhD, is an OSN Cornea/External Disease Board Member. Disclosure: No products or companies are mentioned that would require financial disclosure.

Demand for new products will stimulate development

David R. Hardten

One great American tradition over our relatively short history has been innovation and risk-taking. As our society has evolved, we have become more conservative and less willing to take risk in many areas, and one of those has been in the area of health care advancements. Is this a good thing? Is this a bad thing? What is the right balance? What do the people of the U.S. really want?

As a doctor, trying to act in the best interests of my patient, I would want the ability to have access to every possible device or drug that I felt might be helpful for his or her individual medical problem. As a patient, I would want to trust that my doctor could effectively make those decisions and have access to that device or drug.

Unfortunately, all medications and devices have some associated risk, and we have increasingly put the burden of regulating that risk on the various governmental agencies, mainly the FDA. Because the risk-benefit ratio for individual drugs and devices varies depending on how severe the problem is for a patient, the FDA is left in this nebulous spot of trying to create a process that decides if something is “safe and effective” for a wide range of problems. I believe that this task is impossible.

Recently, the public at large appears to have decided that no complications or side effects can be tolerated from any treatment. We have become a society of practice guidelines and cookie-cutter approaches. If we truly demand that we only will develop perfect therapies or devices, and through patient complaints or legal case law take objection to any imperfection in a system, then the government has no choice but to stifle anything other than the innovation of perfect products.

The process that will allow the government to once again stimulate development of products will be patients demanding new products and allowing us to realize anew that nothing is perfect. That action with some risk is better than conservative inaction. Everything has risks and benefits, and in the end, the doctors, working together with their patients, with appropriate government surveillance, can once again decide what is best for the patient.

David R. Hardten, MD, is the OSN Cornea/External Disease Section Editor. Disclosure: No products or companies are mentioned that would require financial disclosure.