FDA’s Role in Regulating Generic Drug Affordability

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.

Link to Article

Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications

Almost everyone in the United States can agree to the fact that medications are not cheap. Moreover, brand name medications are infamous for being unnecessarily expensive. The issue with expensive medications lies not just within the costs themselves but also within the fact that the costs affect patients’ medication adherence and willingness to receive treatment. Both health care practitioners and patients are often drawn towards brand name products without knowing that the equivalent generic medications may produce equally effective results.

This article describes a study in which researchers conducted a Google Scholar literature review, answering five questions regarding the usage of generic medications, effectiveness of generic medications, and barriers against using generic medications. Articles containing original empirical data that were relevant to each of the key questions were included in this review.

The results of this study demonstrated that many health care providers prescribe brand-name medications when generic versions are available. Furthermore, studies show that when managing common chronic conditions, physicians tend to choose medications that are newer and relatively expensive. “Therapeutic interchange” is the substitution of a similarly effective but less expensive chemical entity to treat the same condition and, when combined with generic substitution, studies have shown that Medicare could save $1.4 billion for patients with diabetes alone.

As I mentioned earlier, high costs are not the only issues in these situations because the impact high costs have on the patients’ medication adherence are just as important of an issue. In a study done on patients initiating therapy in long-term medications, results showed that patients beginning therapy with a generic medication had adherence rates that were 5-7% higher than those initiating therapy with a brand-name drug.

In response to the question, “What is the evidence that brand-name and generic medications have similar clinical effects?” there have been conflicting results. Bioequivalence is defined as “the absence of a significant difference in the availability of the active ingredient at the site of drug action”. While generic versions of bupropion were not found to be bioequivalent to the brand-name version, a meta-analysis of forty-seven studies comparing generic and brand name drugs in nine classes of cardiovascular medications demonstrated that the generic drugs were just as effective as the brand-name equivalents.

The future for generic drug use is still unclear because, while generic drug use has been increasing, there is still a lot of room for even greater use of these medications and for the improvement of health care quality and reduction of costs. The perceptions of patients and health care providers continue to heavily affect the use of generic medications. Many approaches to increasing the use of generic drugs have been proposed, the first one being the development of data demonstrating the safety and effectiveness of generic drugs relative to their brand-name counterparts. I personally am affected by the high costs of brand-drugs and am also guilty of misperceiving generic drugs as being not as effective as their brand-name counterparts. I believe that more concrete data and evidence would play an enormous in increasing generic medication use and medication adherence while substantially decreasing costs.


Choudhry M, Denberg T, Qaseem A. Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med. 2016; 164(1): 41-49