Historically, I have been critical of the FDA, especially around the delay of the approval of Provenge. Now, it is time to take a look at the FDA and what I believe the future will be for this agency. I do first need to make it clear that I do believe that the FDA plays a vital role in protecting us from snake oil and other scams. In reality they have done an excellent job, sometimes not fast enough from my prospective.

The FDA today has many issues facing it including regulatory science, costs, and the organizational challenges. The FDA has been moving more slowly (my issue with the Provenge approval) and will continue to move slowly in the area of drug approvals and diagnostic testing. It seems that in short order diagnostic tests will be approved in a similar fashion, as are drugs, which will also be a slow process.

Costs are going to become a major issue in the same way they are currently in the European approval process (as evidenced by the recent rejection of Zytiga for reasons of cost). I don’t believe that drug costs will become directly involved in the approval process at the FDA, but it is hard to see that they will not be an underlying concern. Certainly, we have seen some evidence of this in the requests that the FDA Advisory Committees have asked of the drug companies. Additionally, some critics do claim that the FDA review process has become fragmented making the review process compartmentalized.

Overall the FDA is slow to approve drugs, they need to find a balance between caution and patience and the terrible need of patients. Caution is important to protect patients, but people die unnecessarily when the caution out weighs the risks.

The drug industry has out paced that FDA in the new innovative areas including immunotherapy, genetics and drug combinations. The FDA has not shown the ability to grapple with new technology like pharmacogenomics. They will eventually develop the needed expertise, but it will take them time which will cost more patients their life.

Joel T Nowak, M.A., M.S.W.