The FDA – Is It Still the Gold Standard?

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Many of us, prior to the pandemic, never thought much about the Food and Drug Administration (FDA). Most of us knew they were the ones that approved drugs but that was about it. We didn’t have strong feelings about them one way or the other. They just did their job in the background, and we enjoyed safe medicine. The pandemic and the rapid accelerated approval of the COVID-19 vaccines thrust them into the spotlight and suddenly everyone, it seemed, had an opinion on how the FDA should operate. The FDA’s time-tested accelerated approval process came under scrutiny and rumors of political influence were rampant. Sadly, this ill-advised mistrust caused some people to turn their back on these lifesaving vaccines . . . vaccines that some estimate saved almost 20 million lives worldwide. With all this controversy some have begun to doubt that the FDA was still the gold standard for the safe and effective approval of medicines. I thought that it would be important to review where the FDA stands today in this very important role.

The FDA, as an organization, is tasked with using unbiased scientific facts to ensure the efficacy and safety of the medicines it approves. Its historical record has proven that the FDA has done an outstanding job. The unbiased requirement has sometimes been tested and the FDA has yielded to outside influences in the past, but this outside influence was not authored by politicians but by the patients themselves.

For example, in 1988, hundreds of AIDS activists surrounded the FDA Parklawn headquarters building to protest what they perceived as a slow and inefficient drug approval process that was preventing patients from receiving possibly effective medicines and costing patients their lives. These protests, organized by the AIDS Coalition to Unleash Power (ACTUP), publicized patients’ concerns to improve access to emergent therapies and pushed the FDA to develop a new accelerated approval process to accompany the new treatment regulations for Investigational New Drugs which was implemented in 1987. This change enabled these desperately ill patients access to these promising new therapies. This accelerated approval process has been used ever since when the circumstances dictate and was used effectively to quickly approve the lifesaving COVID-19 vaccines.

There was another extremely important outcome from these patient protests. In 1987, the huge cultural impact of the AIDS crisis was evident as the AIDS quilt was first assembled on the National Mall in Washington, D.C. In the coming years AIDS Walks were organized across the nation. This was a clear signal of how important the patient was to the FDA’s policy making process. The new Office of AIDS and Special Health Issues was developed to build a relationship with the patient communities, and the FDA made it a requirement to include at least one patient representative on every advisory committee. The advisory committees were also more open and transparent and allowed public comment, an opportunity that I have taken advantage of and testified numerous times.

Over the years, this refocus on the patient has made the FDA more effective and should have diminished the fears people had on the effectiveness of the accelerated approval process for the COVID-19 vaccines, but the din of misinformation and conspiracy theories fogged our vision and led to the lingering distrust that still prevails in some people’s minds. I think it is important to use our 20/20 hindsight to look back at our experience with the COVID-19 vaccine approval process and the resulting effectiveness and safety.

Historically, a typical vaccine takes five to ten years to develop and manufacture. The Pfizer/BioNTech mRNA vaccine was developed and was being administered in less than a year. Prior to this vaccine, the quickest vaccine development was the mumps vaccine, developed in 4 years. Some of the concern as to the safety of the new vaccine was certainly the result of this four-fold reduction in development time. It might not have been as clearly communicated as it should have been that the accelerated approval process and the emergency authorization rules were not altered. The same criteria and adherence to scientific fact that was used in the past was employed. This same methodology was brought to bear when the ensuing variants were discovered, and the vaccines were modified to address these new strains. There is one thing that I think people overlooked as they tried to evaluate the accelerated approval process. The process of developing an effective and safe vaccine wasn’t just the goal of the FDA. A huge company like Pfizer wasn’t about to ruin its business reputation by producing an unsafe vaccine in the spotlight of the pandemic. I suspect their criteria for success might have been more stringent than that of the FDA.

So . . . what was the outcome? The results of the 5.5 billion people worldwide that got the COVID-19 vaccine reveal an extremely safe and effective vaccine. Some have indicated that the COVID-19 vaccine is safer than some of the other vaccines that have been around for decades. Any ill effects on specific categories of people have been miniscule. For me, the results speak for themselves, the accelerated approval process was effective, safe, and timely. Suffering was reduced and lives were saved.

Are there things that can be done to improve the process? Absolutely! I do believe that there were instances of political influence that have crept into the FDA. For Americans to trust the FDA they need to see an impenetrable wall between Congress and the FDA. The voice of the patient needs to be not only heard but recognized. I’ve seen instances where the FDA leaders and advisory committees have only given lip service to the patients and their advocates. They listened to the AIDS patients and it made them better. They need to continue listening.

In reviewing the facts of the pandemic, my 20/20 hindsight has shown me that the FDA is still the gold standard for ensuring our medicine is safe and effective. The FDA needs to do everything within their power to resist any pressure from outside entities, may they be political or in the private sector. The lawmakers need to resist the temptation to alter the goals of the FDA or to influence them in any manner. We need an independent, scientific driven FDA if we expect them to maintain their standing as the gold standard.

Best, Thair

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