The Food and Drug Administration is now looking forward to a new era with the appointment of Margaret Hamburg as Commissioner. Although just about everyone has greeted her arrival warmly, now we will see political pressure from, well, just about everyone. Although many people are familiar with the Vioxx story and the Coast IRB fiasco, there are those who feel quite strongly that FDA is getting too cautious in its approval of new drugs and that the caution stifles innovation. A good place to look at this viewpoint is at Forbes.com (not surprisingly). I am putting a link under “Interesting Articles” for ‘Caution Syndrome’ infects FDA by David Gratzer. There, you will find links to several other articles that, in the opinion of this Blog, are deregulatory in nature and not in the best interests of consumers. However, they are well thought out and not as strident as other discussions about the new administration. I urge you to take a look.
As you may have figure out by now, I have a different opinion. I believe that FDA has been far too lax in its enforcement of the regulations. However, complaints of overly bureaucratic, timid, I don’t want to do anything wrong regulators are sometimes justified. What we need to do, in addition to my comments below in my remarks on Dr. Hamburg’s confirmation, is demand that FDA have the same standards that FDA expects of industry. FDA should have not only professional reviewers and inspectors but highly trained and professional Managersto oversee their work. FDA needs clear regulations that make sense and can be enforced. The most obvious example to me are the GCP regulations that govern clinical trials.
These regulations are long overdue for updating. The clinical research industry (yes, it is an industry) has changed significantly since the 1970s when the regulations were first put into place. Many clinical trial vendors are not regulated at all. The regulations that are in place are vague and lack guidance documents to steer researchers in the right direction. Clinical trials have no requirement for quality assurance activities and quality control is poorly defined (‘monitoring’ is quality control).
Clear, updated regulations along with a professional FDA are what is needed for the development of new health products. More deregulation would be a step in the wrong direction. If you don’t believe me, walk to your medicine cabinet and pull out something that you use, for whatever reason. Can you look at your cholesterol medication, pain reliever, or allergy medication and determine where the ingredients came from? Do you know if they were ever tested for safetyand effectiveness just by looking at them? Can you tell if the dose is correct? Do you know if this a counterfeit drug? If you answered ‘no’ to any of those questions, then you understand why we need a strong, effective FDA.
You can read additional posts on FDA Commentaries here: