This article from The Journal of the American Medical Association makes some suggestions to the FDA on how to manage the affordability of off-patent pharmaceuticals. Historically and currently the FDA stays away from making decisions based on the economics surrounding drugs and drug-pricing. However, this has led to exacerbated issues when it comes to drug cost for generics in non-competitive markets. The article details how in a competitive market if one generic manufacturer dramatically increases the price of their product, another manufacturer can sell the product at a much lower cost and do well in the market. However, in a non-competitive market, if the sole manufacturer of a generic drug decides to increase the price, people have to pay the price set by the manufacturer in order to get the medication. Additionally, when there have only been one or two manufacturers of a drug historically, a drug shortage can easily occur. If those one or two manufacturers fail temporarily or increase their prices drastically, the United States is unable to obtain their specific drug product and get it to patients affordably except by importation from other countries. The article asserts that it would do the drug industry good in the U.S. if the FDA began involving itself in issues of drug-pricing regulation and management. Suggestions from the article include changing the FDA’s generic drug application review process by prioritizing drugs that would fall into a non-competitive market if approved, temporarily permitting compounding of drugs that are facing shortage issues due to manufacturer failure or dramatic price increase, and permitting importation of drugs from reputable sources in the instance of a shortage.
I believe I am of the same opinion as the article: that it is the FDA’s duty to protect the public, and the service of regulating drug-costs falls under that category. If a life-saving drug’s price skyrockets for the benefit of the manufacturer and a patient is no longer able to purchase the ridiculously high-cost medication, the FDA has failed in one way. If the FDA were to change their ways it could have an incredible impact on the drug market in the United States, for better or for worse. Do you think the FDA should play a role in drug price regulation? Or do you tend to think that drug companies are companies like any other and should be able to price drugs how they please?
Greene JA, Anderson G, Sharfstein JM. Role of the FDA in Affordability of Off-Patent Pharmaceuticals. JAMA. 2016;315:461-462.