The “New” FDA

The “New” FDA

Back on June 11th Margaret A Hamburg, M.D. and Joshua M. Sharfstein, M.D. , the incoming FDA commissioner and deputy commissioner of the FDA, published an article in the New England Journal of Medicine entitled “The FDA as a Public Health Agency”. According to the article; “The Institute of Medicine has defined the mission of public health as “fulfilling society’s interest in assuring the conditions in which people can be healthy.” To be healthy, people need access to a safe and nutritious food supply and to innovative, safe, and effective medical products. The FDA’s job is to support this access and, in doing so, to promote health, prevent illness, and prolong life. The ultimate measures of the FDA’s success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved.”

The article goes on to state (Diabetic Investor added the highlighting):

“Indeed, one of the greatest challenges facing any public health agency is that of risk communication. We all accept small risks in our daily lives, from the risk of falling in the shower and sustaining a head injury to the risk of having a car accident on the way to the grocery store. One reason we are rarely fearful of these risks is our perception that we have control over them. When it comes to food and drugs, even small risks can cause considerable fear and anxiety, especially when they seem to be out of our control. Yet all pharmaceuticals have some potential adverse effects, and many raw foods may harbor natural pathogens.

The FDA’s job is to minimize risks through education, regulation, and enforcement. To be credible in all these tasks, the agency must communicate frequently and clearly about risks and benefits — and about what organizations and individuals can do to minimize risk. When, like the FDA, Americans must make choices about medication, devices, foods, or nutrition in the absence of perfect information, the FDA cannot delay in providing reasonable guidance  — guidance that informs rather than causes unnecessary anxiety.

For these communications to have credibility, the public must trust the agency to base its decisions on science. We recognize the importance of a management approach that respects the expertise and dedication of the FDA’s career scientists. In recent years, the agency has struggled to handle controversies involving the safety of regulated products, opening the door to legitimate questions from the media, the public, and Congress about whether the public  interest is being served. Establishing  the FDA as a public health agency requires a culture that encourages scientific exchange and respects alternative viewpoints along the path of decision making. It also requires that the agency define and protect integrity in its basic processes."

Although this is just an article it was refreshing to see that the new FDA commissioner understands that all drugs carry some degree of risk and those risk must be balanced against benefits. It was also reassuring that the new commissioner understands the role the media plays.  Lastly drug companies should feel somewhat better to see the statement that the agency should base their decisions on science. The question is can Dr. Hamburg move beyond words and actually turn this struggling agency around.  

Diabetic Investor suspects we’ll see the first glimpse of the “new” FDA as they consider Byetta LAR for approval and examine how to proceed with Liraglutide. There is clear scientific evidence that both drugs are powerful tools for patients with type 2 diabetes.  It is also clear that neither drug is free from adverse events, the question is do these events outweigh the many benefits of these medications. Given that diabetes continues to grow at epidemic rates and that nearly two-thirds of patients are not achieving control will the agency move diligently in their review or will they continue to move at glacial speed? 

It will be equally interesting to see how the “new” FDA handles the PQQ issue facing some blood glucose monitoring companies.  Will the agency take the responsible approach or will they take drastic action? 

This is not the first the first time we have heard good words coming from a government agency. Nor would anyone disagree that the FDA is in desperate need of reform. The question remains can Dr. Hamburg move beyond words and actually implement the reforms outlined in this article.  All too often when it comes to reform good words fail to translate into real action. As Michael Rossman once sated; “The standard reaction to pressure for radical change is to buy it off. Across America, a strategy of campus containment is emerging, which reads: grant with relative grace the minor changes and options that don’t endanger or change the system itself.”