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Progress being made to improve FDA approval process
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There are many important constituencies that are critically dependent on America remaining active in research and development into new drugs and devices to preserve, restore and enhance health.
First and foremost is the patient who suffers from a disease and goes to bed every night praying for a better treatment or, cherish the thought, a complete cure. Right behind the patient is the physician and other health care providers who have committed their careers to help enhance public health, treat the sick and alleviate suffering.
Supporting this effort is the industry that translates the research and development into market-available drugs and devices that can be utilized to benefit patients. This industry, besides serving a very positive purpose, also employs nearly 1 million Americans in high-paying jobs and remains one of the few industries in America with a positive balance of trade. No other country has developed so many effective treatments utilized worldwide in the past 50 years, and it is a success story of American capitalism worthy of some national pride. Overseeing this process of drug and device approval and commercial launch is the U.S. Food and Drug Administration.
Everyone agrees that the responsibility delegated to the FDA is of extreme importance to patients, providers and industry, not only in the U.S., but worldwide. Everyone also agrees that the responsibility delegated to this government agency is a daunting and in general thankless task. Many of us who have worked closely with industry to help develop the next generation of solutions for our patients’ unmet needs have been concerned that the regulatory process to approval in the U.S. has in the past decade become less predictable, less transparent and overly obstructionist with punitive timelines and extraordinary costs. This is undesirable because it discourages investment in the next generation of drugs and devices, leaving patients to suffer with less-than-ideal treatments and damaging one of America’s greatest industries.
On the other side, some consumer advocates push for an even more restrictive FDA, arguing that drugs and devices must be nearly or even totally risk-free before applied to the American public. All physicians and most patients know this is an unreasonable standard.
In a thoughtful recommendation regarding the role of the FDA, the Institute of Medicine recommended a complete overhaul of the FDA regulatory framework. Its very reasonable recommendation called for the new regulatory framework to “be based on sound science; be clear, predictable, straightforward and fair; be self-sustaining and self-improving; facilitate innovation that improves public health by making devices available in a timely manner and ensuring their safety and effectiveness; use relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and efficacy; and be risk-based.” To these I might add that the process be navigated at a reasonable cost so that investment in innovation in the life sciences remains attractive to the sources of capital. To me, this is a set of recommendations very worthy of broad support.
So, is anyone listening, or it just more rhetoric and politically expedient hot air? Fortunately, the answer is fairly promising and, to some, amazing. The FDA, in response to constructive dialogue with industry and some encouragement by Congress, to which it is accountable, is re-engineering the approval process for drugs and devices in a manner reasonably consistent with the Institute of Medicine recommendations.
I can speak from personal experience that the FDA leaders and staff that most impact ophthalmologists, including Jeffrey E. Shuren, MD, JD, Malvina Eydelman, MD, and Wiley A. Chambers, MD, are definitely to be congratulated for being accessible, transparent, predictable and fair in their recent deliberations. They are in my opinion sincerely committed to improving the regulatory process to the benefit of all. The next time you see them — and you will see them, as they are making themselves increasingly available at our meetings — surprise them with a thank you.
With reasonable funding now approved for the device sector through negotiations with AdvaMed and continuing support from the pharmaceutical industry for the drug sector, there is for the first time in a while some reason for optimism regarding increased access to new drugs and devices in America.
If the current momentum builds and the FDA remains supportive of innovation that improves public health at a reasonable risk and cost, we can anticipate a significant increase in investment in new devices and drugs by venture capitalists and companies large and small. While I know how much my children enjoy their electronic games and Internet social networking sites, I would be more than pleased to see some of the billions of dollars invested in these areas return to solving our patients’ and society’s unmet health care needs.