Generic medications are supposed to be the answer to affordability; however the issue of generics is incredibly complicated. On one hand, pharmaceutical companies use an incredible amount of resources to develop medications and get them approved by the FDA. On the other hand, the high cost of these medications when passed on to the consumer can be prohibitive enough that many insurance companies exclude them from coverage, leaving effective medication out of reach. That causes the market to shrink to such a small segment of the population that can actually afford, or be willing to pay for, a medication that it ceases to become viable and goes off the market – allowing for the patent to be bought by another company. These issues have been the subject of significant political and economic debate, driving a wedge between doctors, their patients, pharmacists, and their insurance companies… never mind the companies producing and distributing the drugs.
So this is why name brand still matters.
What Is a Generic Medication
These are exact replicas of brand-name medications with the same “dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same…” (Source). The generic drugs are regulated by the FDA and have to be just as safe and effective in treatment as the name brand drugs do.
Generics come about at the end of the patent life of a drug developed by a company who was awarded the rights to be the sole developer and seller of that drug. Patents are for a limited amount of time. “As the patent nears expiration, manufacturers can apply to the FDA for permission to make and sell generic versions of the drug; and without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply. When multiple companies begin producing and selling a drug, the competition among them can also drive the price down even further… Many companies manufacture both brand-name and generic drugs. In fact, the FDA estimates that 50% of generic drug production is by brand-name companies.” (Source).
The Value of Generics: Who Loves Them
Insurance companies and pharmacists have a strong preference for generic medications because of the profit margins involved. Typically these are businesses whose base concern is the bottom line. Businesses exist to make money, and without enough profit they cannot stay in business. Generic medications play a large roll in the economics of this.
In the case of dermatological medications, there has been some research done regarding how generics have helped to drive the market overall; keeping some of the cost of name brands in check as those name brand medications lose some of their market share to the cheaper alternatives:
Over the past decade, drug prices for commonly prescribed dermatologic medications have exceeded the rate of inflation and reimbursement. In a retrospective cost analysis of the most commonly prescribed topical dermatologic generic drugs published online in JAMA Dermatology, researchers explored the association between drug price and market competition among the most commonly prescribed topical generic medications in dermatology. “Our study helps us understand some of the reasons that we have seen dramatic increases in the costs of topical medications over the past several years,” says principal investigator Arash Mostaghimi, M.D., M.P.A., M.P.H., of the Department of Dermatology at Brigham and Women’s Hospital in Boston. (Source).
Previous research by Dr. Mostaghimi and his associates demonstrated a large increase in the price of topical steroid medications over the past few years. “This has resulted in increased costs for Medicare and for individual patients,” Dr. Mostaghimi tells Dermatology Times. “We wanted to evaluate whether reduced market competition may play a role in these higher prices.” Studies have shown a role for robust generic market competition in reducing drug prices among non-dermatologic medications, the authors wrote.
Why We Still Like Name Brand Medications
Despite the FDA’s oversight, there are plenty of lingering concerns about the efficacy of generic drugs used to treat dermatological problems. The New York Times highlighted this in a 2018 article, “All Generics Are Not Equal”, in which it points out issues associated with F.D.A rules governing generic drugs. While the rule states that the new generic version must “have the same active ingredient, strength and dosage form” as the brand name or reference product, the only test that a maker of a generic medication must perform to receive F.D.A. approval is one that establishes the “bioequivalence” of the product. As a result, this test is done on healthy volunteers and compares the blood levels of the reference drug to the generic one.
Consequently, some specialists believe that “this allowable range for bioequivalence is too wide…”
For some this can have life threatening consequences, which is not usually the case for our clients. However, Practical Dermatology further highlights this issue as it relates to topical generics, indicating:
Bioequivalence is measured by the stability of the active ingredient rather than how well the vehicle is tolerated,” says Neal Bhatia, MD, Associate Clinical Professor at the University of Wisconsin Medical School. He further notes that a generic formulation meeting the FDA standard of bioequivalence may be poorly tolerated by the skin, resulting in a greater likelihood of adverse events and compromised efficacy. Given the importance of the vehicle to both the safety and efficacy of a drug, the specialty of dermatology appears to be at a disadvantage when it comes to generic formulations due to the high proportion of topical treatments in its drug repertoire….Given these conditions, the variability in safety and efficacy in generic formulations can be much greater and the results more unpredictable. For example, according to Dr. Bhatia, a generic version of imiquimod has in his experience been associated with patients experiencing greater discomfort and burning of the skin due to changes in the vehicle from the brand. Other drugs, primarily inherently irritating agents, such as tretinoin, can also have a variable incidence of adverse events… Some dermatologists prescribe brand name agents whenever possible to ensure that patients receive a drug that has been formulated carefully and has been adequately tested.
Thus, if you want to be certain how the drug you prescribe will interact with your client’s skin, you want to make sure that you are sticking with name brand drugs.