Something I've written about before is the swing of the pendulum from the 1990s to the 2000s in terms of public priorities for the FDA. What is the balancing act between risk and benefit when it comes to both food and drugs?
In the 1990s there were two unrelated issues that were prominently influencing our outlook in both food and drugs.
On the food side, globalization in trade was bringing an unprecedented amount of delicious and even exotic foods to the tables of Americans – and bringing it year round. People liked it. People wanted more of it. You could get berries grown in Chile to your table within almost no time. In the middle of winter, you could have a table full of the best that summer has to offer, and in a wider range, with fruits and vegetables people had never seen before.
Lately, however, it has come to our attention that other countries may not have very thorough means of inspection or very ethical producers and fish and dog food and other foods were found to be contaminated with harmful elements. Suddenly globalization didn't seem so hot.
On the drug side, there was a burgeoning HIV/AIDS epidemic. There were no treatments for it, there were only treatments for the vast array of opportunistic infections that people with AIDS suffered. There was a great deal of desire for a cure or at least a treatment that aimed at the underlying cause of AIDS, which was HIV. But the average length of time for a drug's approval was 18 months. That wasn't good enough. Congress set into motion mechanisms that allowed fast track approvals for life threatening drugs and put into place the user fee system that underwrote much faster consideration of drugs for approval, bringing the approval time in most cases down to 10 months. By 1997, with new anti-HIV drugs entering the market, mortality dropped nearly 50% in one year.
Then in 2002, there were some problems with some of the drugs that were being approved, most notably the issues connected with the COX-2 inhibitors, but there were others. And, globalization figures in here too, when the recent contamination in the drug heparin surfaced and was traced back to elements made in China, we realized that many of the components that go into the production of our drugs were not made in the U.S.A. Suddenly, the whole system got questioned.
There is no question, that the last eight years have seen a minimization of efficiency and priorities at the FDA. The FDA can and needs to do a better job. But how risk averse have we become. Is it realistic to expect the FDA to be able to inspect every foreign facility for food production and trace the foreign web of drug production? And do we really want to sacrifice a system that has saved many more lives than it has harmed by doing, as some have advocated, something to the system for quicker approval of drugs? Apply a risk/benefit ratio to that idea and you can quickly see that it is not worth it.
Policymakers need to really evaluate the public interest first, not the latest current public state of mind, when it comes to reform. The panacea is reflected in a recent report by the General Accounting Office that was titled – Seafood Fraud – FDA Program Changes and Better Collaboration Between Agencies Could Improve Detection and Prevention – but the headline that turned into in the media was this – "FDA Accused of Doing Little to Prevent Seafood Fraud" – which isn't exactly the same thing, is it?
As the pendulum has moved from our desire for access to a desire for safety, we have to ask ourselves how risk averse are we – and are we really willing to risk what progress has been made in favor of asking for risk mechanisms to be put into place that are neither realistic, or in many cases, desirable?