The Food and Drug Administration (FDA); An Essay on Unresolved Issues
An Unresolved Issue in the Drug Industry
The purpose of the Food and Drug Administration (FDA) is to regulate the quality and safety of our foods and drugs. The FDA forces regulation on product quality, tests new products determining whether or not that product meets FDA standards, and dedicates itself to research and development in the medical treatment field. As the remaining authority for the drug market, this administration has been the driving force of many significant changes since its founding in 1906. Thanks to the introduction of this branch in government, the American standard regarding quality in our country’s food and drug manufacturing industries has been properly adjusted throughout the years. Although the FDA has been a wonderful contributor to the American society, there is an unresolved issue between itself, congress, and the pharmaceutical industry. This administration is still working on its focus of consumer safety during drug review processes (without compromising approval deadlines), as well as initiating motions through congress that are pro-consumer. The FDA has been increasingly successful in this over the past two decades yet there remains a contradiction. Due to the relationship the FDA has within the context of congress and the pharmaceutical industry, the American consumer market (as well as international consumer markets) have been negatively affected.
This administration is strongly focused on paid research and development contracts, but neglects to configure a sensible relationship within the American consumer market. When the health of Americans rests in the hands of greedy monopolistic entities such as the drug manufacturing giants, there will be a less than justified end result. Economically speaking, any monopoly is going to be less efficient than the competitive monopoly. The Drug Price Competition Act and The Patent Term Restoration Act (also known as Waxman-Hatch Act of 1984), allowed generic drug manufacturers to bypass FDA research for approval due to the bioequivalence of these drugs; meaning that it was finally acknowledged through congress that a drug of the same chemical compound would not need to go through rigorous testing to prove its efficacy and use. The problem with this is that there still remains a patent life for pioneer drugs, forcing consumers to endure extremely over-priced drugs for years and years until patent life expires.
The Prescription Drug User Fee Act (PDUFA), passed in 1992, initiated funding of the FDA directly by drug companies. Of course there was good reason for this bill; PDUFA requires the rich drug manufacturing companies to pay fees that subsidize FDA programs. This increased funding by a large margin to support a substantial collective of scientific studies. By financially supporting a growing workforce, this significant bill allowed for quicker review deadlines regarding life threating diseases. Review deadlines have been reduced by nearly threefold, from an average review length of two to three years, to under a year. The negative consequences on the other hand, need to be analyzed. Firms that require their products tested and reviewed -for approval to permit marketing- have become sponsors for the drug administration. This (like a multitude of FDA approvals) has had adverse effects; the FDA’s plight between choosing a safe, thorough approval process, approving drugs as soon as possible for the millions of those with rare diseases (eagerly and desperately waiting for the proper drug treatment), and the much needed funding that comes once the approval phase and marketing phase are underway. Sidney Wolfe, director of Public Citizen’s Health Research Group (since its founding in 1971), states that there is an unhealthy relationship between the FDA and the pharmaceutical industry. Wolfe conveys that the FDA tries to avoid conflict, and attempts to please the industry. The industry firms are viewed more as clients than as companies that require regulation (PBS). The pharmaceutical industry lobbies for fast review, it does not lobby for safety, this in itself should tell you something. Actions speak louder than words. The actions are intended for financial purposes, mutually shared interests among the corporate drug world and the Food and Drug Administration. The fearful issue here is that by lobbying to congress, drug manufacturing giants have been successful in using their financial power to bend the rules.
Without a profit motive, there is little incentive for manufacturers to pursue the marketing of potential lifesaving drugs. The reality is that people don’t get saved for free, and that a lot of research can go into finding treatments. Drug companies don’t find their place by treating a rare disease, which offers a small consumer market, they go for larger markets. Although, the enactment of The Orphan Act in 1983, finally brought some justice to those with rare diseases (including the AIDS outbreak and the introduction of AZT), giving tax breaks, subsidies, and special exclusivity privileges to “orphan sponsors”. In the summer of this year, CEO Martin Shkreli of Turing Pharmaceuticals fully endorsed his decision to raise the price of Daraprim by over 5,000 percent. The cost for one Daraprim tablet sky-rocketed from $13.50 to $750.00. Mr. Shkreli says he would raise the price even higher, and that due to a capitalistic market he feels he’s in every right (Miller).
To ignore the history of FDA interactions would be making a mistake. Not only has the FDA been responsible for dangerous drugs to enter the market, it has also proven to stand-by while further harm is dealt. In the past 10 years there have been 31 incidents where the anti-trust clause The False Claims Act was violated. To no surprise it was the drug manufacturers at fault for illegally attempting to commercially promote uses without FDA approval. There is irony here, for example, FDA restriction on off-label use has always been of a hindrance to the treatment of those with rare diseases. The history of off-label drug use has proved effective; one of the ways that rare ailments may be treated (among those who are in desperate need, consenting under the guidance of their trusted physician), is for a patient to use a drug for a purpose that has yet to be proven effective. Not only are patients forced to cope with less alternatives, stringent regulation on off-label use has been stifling potential trial situations. The industry hand on FDA interactions has proved anti-consumer. FDA staff has already attested to the pressure forced upon them to meet approval deadlines (on non-life saving drugs which is of a higher opportunity cost to market pre-maturely) for funding purposes as well as in acquiescence to the wishes of pharmaceutical corporations; these orders deriving from higher ranking officials. Unfortunately, congressional influences are primarily pro-industry as opposed to pro-consumer, and while the FDA operates under the influence of congressional implementation, this creates the gateway for a problem. PDUFA V was passed in 2015, extending this piece of legislation into late 2017. There is hope for further success in health and safety of drugs; however, the access that patients have to these drugs may be irrelevant as long as these corporate patents exist. The drug application process and its success in reaching much quicker deadlines is only one half of the solution, the affordability of these lifesaving drugs is just as important.
Word Count: 1,179
Works Cited
"Significant Dates in U.S. Food and Drug Law History." FDA.gov. N.p., 19 Dec. 2014. Web.
Kronquist, Amanda Rae. "The Prescription Drug User Fee Act: History and Reauthorization Issues for 2012." The Heritage Foundation. N.p., 21 Dec. 2011. Web. 09 Dec. 2015.
Miller, Michael E. "‘Pharma Bro’ Martin Shkreli and the Very American Debate over Maximizing Profit." Washington Post. The Washington Post, 23 Sept. 2015. Web. 09 Dec. 2015.
Klein, Daniel B., and Alexander Tabarrok. "FDAReview.org, a Project of The Independent Institute." FDAReview.org, a Project of The Independent Institute. Independent Institute, n.d. Web. 09 Dec. 2015.