Balancing Act: drug innovation's FDA-dependence

Pharmaceutical science is nothing new. It's existed for ages, if we are to count all those hocus-pocus witchy brews made in antiquity. But the issues faced in pharmaceutical science as we know it today-- drug innovation-- began in the 20th century, in-step with booms in biomedical sciences. With the growth in drug possibilities, it became necessary to have a check-point to ensure the safety and regular marketing of drugs. Enter: the FDA. Beginning in 1906, new drugs needed to pass through an FDA-approval process before becoming available to the general public.

Indeed, this process has been totally integral to public well-being. The FDA-approval process eliminates guesswork on behalf of consumers by instituting investigations of drug safety by professionals.

But During 1980’s, America faced a serious “drug lag” where, due to a lack of resources at the FDA, the drug-approval process was too slow to keep up with demand. As a result, congress passed legislation which made pharmaceutical companies pay a “user fee” with each new drug application. So while the FDA is a government entity, these private funds play a large role in mitigating the cost of approval. The benefits have been ample, such that in 2012 congress passed renewed this act for the fifth time! However, some claim that industry funds in the drug approval process has led to questionable and hasty marketing of unsafe drugs. Furthermore, these “contributions” may have led to a decrease in drug efficacy and design ingenuity. Others say, however, that these payments are actually quite penalizing for pharmaceutical companies. An undercover relationship between pharmaceutical companies and the FDA makes for a juicy story, but in reality, each face the painful balancing act between getting life-saving treatments to sick patients and ensuring drug safety.

In the 1980's, U.S. drug approval lagged behind other modern countries.

The relationship between the private sector and a large government agency like the FDA clearly reminds me of the Gilded Age. During this period, the hand of government in regulating business ventures was practically nonexistent. Later, congress passed laws to control monopolies and questionable market ethics. However, the relationship was (and since has been) a very touchy one, filled with corruption and political blight. Could this be happening with the FDA and “big pharma”?

Pharmaceutical research and development also opens up “brave new worlds” metaphorically as explorers in the 15th and 16th centuries did literally. In both cases, the “explorers” (scientists or sailors) relied on venture capital to proceed with potentially amazing adventures. And in both cases, they often worked with the government to achieve a common goal. However, one must ask whether the FDA’s increasingly tight regulations stifle meaningful drug innovations and work against the “common good”.