Mark Twain is quoted as saying: “If I had more time, I would have written a shorter letter.”

What Is an FDA ADCOM?

Pharma and device companies seeking approval for their products are often required to present their data to an FDA advisory committee meeting (ADCOM). They have a limited time in which to tell their story. Therefore, Pharma must know how to “write the short letter.” This requires them to condense years of research into messages that can convey the most salient, and most pertinent, data to a jury of scientists.

If a pharmaceutical or device company develops a treatment, and the product doesn’t receive Food and Drug Administration (FDA) approval, then the outcome is clear: the treatment, for all practical purposes, does not exist. That can be a good thing, and it is the reason why the FDA exists. The FDA must protect society from drugs and devices that fail to meet a minimum level of efficacy and safety.

Although the FDA has the final say over whether drugs and devices are approved for use by the general public, they will frequently ask for input from scientists who are renowned in the area of medicine where the products will be used. These experts make a recommendation about whether or not to approve a product. Their recommendations have great influence, but the FDA is not obligated to follow their recommendations.

You can read about how drugs are developed and approved here.

Why Research Is Important

Pharma and device companies are often vilified by society and the media for their pricing. However, sometimes, we celebrate with the same companies when they announce breakthroughs that can save lives, or dramatically improve the quality of one’s life. Polio vaccine, treatments for HIV, pacemakers, and chemotherapeutics that have cured pediatric cancers are but a few examples of medical advances that have saved lives. We are always hoping for the next major discovery. For example, Michael J. Fox fans around the world await a cure for Parkinson’s.

But research alone isn’t enough. After a medical discovery, Pharma and device companies have to prove to the FDA the new product is safe and effective, and that it should be made available to the public. This is when ADCOMs can play a role. ADCOMs are asked to critically review the data on a product, and make recommendations to the FDA about whether the products should be approved. Not all products must go before an FDA ADCOM. The FDA determines which products require this step.

Who Is on an FDA ADCOM?

Members of the ADCOM are very bright, and most are esteemed scientists with long careers as researchers and clinicians. Most committees also include someone from the public at large who generally has some personal interest in the area of medicine that is being discussed. For example, at the Division of Anesthesia, Analgesia, and Addiction Products, a person experiencing chronic pain is often invited to participate and vote on the recommendations. The committee members, therefore, may not all be subject matter experts.

Most people probably don’t appreciate the work that goes into preparing for a meeting with the FDA. It takes thousands of hours to construct the concise story.

Companies are under considerable pressure to make their case in about 90 minutes. It is crucial that the company presenting to the FDA ADCOM be able to deliver its messages effectively. To do this, most companies will hire consultants who know how to best present the data with translucency, simplicity, and unquestioned integrity.

My Own FDA ADCOM Experience

I have had first-hand experience in observing how one consulting group, 3D Communications, has helped several companies prepare the “short letter” to the ADCOM. Staff members from consulting companies like 3D Communications comb through an enormous amount of very complex scientific data to create a logical, honest, and powerful narrative. The storyline must logically build to a climax and end, as all great stories do, with a summary of the evidence and a resolution. I have been impressed with the expertise of 3D Communications. It is the equivalent of having a great storyteller on your team.

In presenting my research to the FDA ADCOMs, I have gained an appreciation for the work and expertise involved in preparing for an ADCOM. But, I have also grown to respect the thoroughness of the FDA review process. If more people understood this, there would likely be a greater appreciation of the process that takes our drugs from discovery to the drugstore.

A key step in the process may be a presentation to an ADCOM. Here a product may win support or not, but clearly, a factor that may make the difference is how well the short story is written and delivered.

Purchase my book The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us (available on Amazon) or read a free excerpt here.

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Copyright 2016, Lynn Webster, MD