Today we probably have more food coming into the US from more places than ever before. We have oil spills threatening the Gulf food supply. We have more biologic drugs than ever before and legislation has passed and awaiting regulatory procedures for a new era in biosimilars, which will require special new oversight by FDA. We have had more drugs out in the market place for longer than at an previous time, meaning that the range of adverse events associated with wider use than during clinical trials will grow – witness the most recent emergence of safety questions with Avandia. Diseases exist today that 30 years ago were completely invisible to us (HIV, e.g.). In other words, in almost every category of the FDA's regulatory jurisdiction, risk has grown.
Not only does risk grow as a result of an increased array of food and medical products, we even spend a great deal of time looking for risk where we didn't know it existed. Consider the absolute plethora of studies and claims that inundate we consumers to the point where we are getting fatigued by their emergency. For example, how about this – a claim that too much milk can cause cancer (actually can't too much of anything cause cancer?). Is caffeine associated with arrhythmia? Or does it protect us from Alzheimer's? Risk is far more our obsession than a focus on benefit.
Is anything safe? Do we have to be protected from everything? Can we? Should we?
A huge proportion of what we consume, whether food or drugs, comes from outside of our borders. In 2008, Health and Human Services announced that the FDA would be opening offices in China and that the first staff was anticipated to be "a total of eight U.S. nationals." In the words of then-HHS Secretary Mike Leavitt – "We're making stead progress to better safeguard our supply of food and medicines, though much work remains…." The press release announcing the intention to open offices also states that there were plans for overseas offices in India (by mid-2009, where 10 U.S. nationals would be placed), Europe, Latin America and the Middle East. Is it possible to put enough people in enough places to safeguard the food and drug supply outside of the nation? The question becomes especially significant when there is no real capacity for tracing many foods within our own borders to their source.
Last week, the Inspector's General Office of Health and Human Services issued a report entitled "Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials that stated estimated between 40 and 65% of clinical trials that were being conducted for products that would be considered for approval in the U.S. were being conducted abroad. The findings concluded that 80% of marketing applications for drugs and biologics included information from foreign clinical trials, yet the FDA inspected less than 1 % of foreign sites. One of the recommendations was that FDA should continue to explore ways to expand oversight of such trials.
With such a proliferation of risk, can we afford the degree of global oversight needed to ensure safety? Or is it simply a matter of prioritization? Is it time for FDA to enunciate a strategy outlining where it puts its time and resources to guard against which specific risks? Without such priority setting, the risk to the agency, and its reputation, is that in trying to appease our growing desire for risk aversion by providing safety in all situations in all countries, the overall standard of safety may be lower, not higher. Perhaps the priorities have been set, but observationally, one sees a vast horizon on which the agency must operate, without a match in resources. That is particularly true at a time when budgets and funding, unlike risk, is not increasing geometrically and may not be increasing much arithmetically.