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Regulation of food and drug safety is such an accepted part of Americans’ daily lives, it is easy to forget that people did not always enjoy this security. The 1906 Pure Food and Drug Act regulated the types of drugs which could be legally sold in the United States as well as prohibited food tampering and adulteration (Glass 2014). The Act’s passage ensured that proper testing is necessary to show that drugs are both safe and effective. Today, the process by which drugs are approved by the Food and Drug Administration (FDA) remains controversial. Many scientists allege that the process is too easy, particularly when trials are sponsored by powerful pharmaceutical companies.
While the 21st Century Cures Act was designed to streamline FDA approval, its critics have alleged that it will “weaken already weak rules for device approval that have led to thousands of complaints” (Loria, 2016, par.32). Even before the passage of the Act, studies indicated that the FDA already approved most drugs and a BMJ study suggested that even when new drugs in the streamlined process are not actually harmful, they often do not show demonstrable benefits over and above drugs currently available on the market. (Loria 2016). Because these drugs are patent-protected and do not have generic alternatives until their patent expires, they thus are more expensive but not necessarily cheaper and better than what is available.
Thus, the current system rewards larger pharmaceutical companies that have the money to create research studies that technically satisfy the FDA’s requirements but does not necessarily encourage innovation. One proposed improvement would be to demand that all new pharmaceuticals show substantiated benefits both in cost-effectiveness as well as quality comparable to what is currently offered on the market. Current population trends suggest that more and more American consumers will have greater out-of-pocket expenses for their healthcare, due to a rise in copays and monthly premiums. Keeping drug costs low is essential. On the other hand, genuinely incentivizing cheaper and truly innovative treatments should be encouraged.
Reference
Glass, A. (2014). Pure Food and Drug Act passes, June 23, 1906. Politico. Retrieved from: https://www.politico.com/story/2014/06/fda-theodore-roosevelt-108164
Loria, K. (2016). Why exciting ideas for cures almost never make it to patients. Business Insider. Retrieved from: http://www.businessinsider.com/why-its-so-hard-to-get-drugs-approved- 2016-3
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