With the onset of the patent expiration on Gleevec of the patent expiration on Gleevec for CML expiring in July and for GIST in June 2022 in the United States, it becomes more important than ever to understand the implications when a brand name drug becomes available as a generic. Navigating the waters of generic vs. brand drugs requires an understanding of what this means for the consumer. Equally important is being aware of the existence of substandard and counterfeit drugs in the marketplace.
A generic drug, according to the FDA, “is identical—or bioequivalent—to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are bioequivalent to their branded counterparts, they are typically sold at substantial discounts from the branded price.”
Before being approved by the FDA, they undergo a rigorous quality control process to identify quality, purity, strength, potency and the ability to reach required levels in the bloodstream at the right time and to the same extent.
“Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:
- contain the same active ingredients as the innovator drug (inactive ingredients may vary)
- be identical in strength, dosage form, and route of administration
- have the same use indications
- be bioequivalent
- meet the same batch requirements for identity, strength, purity, and quality
- be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products”
What must be taken into consideration, however, is that some variability occurs in the manufacturing of both brand and generic drugs. The FDA limits the amount of variability, outlining acceptable standards.
Generic drugs are not required to contain the same inactive ingredients of the brand drug, however. This can include flavorings, fillers and preservatives. For some patients, this can mean that your body may react differently to the fillers in the generic medication.
The generic version of your medication may also differ in size, shape, color, and packaging.
Manufacturers of generics need to prove that their drug is the same as the brand name drug. This is referred to as bioequivalence.
An example of bioequivalence would be the rate and extent of availability of the active ingredient after administration. Scientists perform tests to measure the differences between the way the brand and generic drugs are absorbed into the body. Bioequivalent value is within the 80-125 percent test reference ratio. The FDA has conducted studies that show that the average variation is 3.5 percent.
The FDA reviews the bioequivalence. All generic drugs must also have their manufacturing process, packaging and testing sites held to the same quality standards as the brand name drugs.
Most generic drugs carry a significantly lower price than the brand name equivalent. This does not necessary mean lower quality, but the consumer should monitor information about the generic form of their medication, discussing it with their physician.
The high cost of medications often leads the consumer to seek alternative sources for obtaining the drugs at lower costs. Unfortunately, this can lead to unsafe purchasing practices, including seeking to purchase low-cost medication via the internet.
Counterfeit and substandard drugs
Fraudulent online pharmacies may attempt to sell illegal generic forms of medications.
Referred to as “counterfeit,” these medications are fake versions of brand name medicine. They may contain the wrong active ingredient, or contain the right ingredient at an inaccurate dosage level.
As defined by the FDA, “Counterfeit drugs as those sold under a product name without proper authorization. Counterfeiting can apply to both brand name and generic products, where the identity of the source is mislabeled in a way that suggests that it is the authentic approved product. Counterfeit products may include products without the active ingredient, with an insufficient or excessive quantity of the active ingredient, with the wrong active ingredient, or with fake packaging.”
The FDA estimates that counterfeit medications make up more than 10 percent of the global medicines market and are present in both industrialized and developing countries.
The World Health Organization defines a counterfeit drug in this way, “A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”
Taking these medications can be extremely harmful to your health.
As a consumer, it is important to know that the only way to ascertain if a drug is counterfeit is through laboratory analysis.
The Food and Drug Administration acts as a watchdog agency to assure that consumers are protected against counterfeit or unapproved medicines. They work closely with other agencies to provide alerts to the public when these medications are discovered.
The Partnership for Safe Medicines is another source of valuable information on counterfeit drugs
It is vital to obtain your medications through a reliable source such as licensed pharmacies.
The FDA provides a Consumer Safety Guide to buying medicine online on their website.
Substandard drugs are products generally produced by legitimate manufacturers whose composition and ingredients do not meet the correct scientific specifications resulting in inefficiency of therapeutic results, which may harm the patient. They fail to meet the regulatory authority’s specifications.
Unlike counterfeit medications, substandard drugs may occur due to human error, negligence, lack of resources to provide quality manufacturing processes, or inadequate quality control processes.
Although counterfeit drugs are also “substandard,” there is a more deliberate intention to deceive the consumer.
More attention is paid to counterfeit drugs, but negligent production can pose a significant risk to the health of the consumer. “Different amounts of active ingredients lead to different health outcomes, prices and potential remedies. With no correct active ingredients, falsified drugs constitute no treatment at all, and may even be directly harmful.”
According to a study cited by the British Journal of Clinical Pharmacology, “Substandard drug manufacture also leads to morbidity and mortality. A formulation with insufficient API (active pharmaceutical ingredient) may lead to a lack of clinical response, and possibly death. Adverse events can also occur due to drug-drug interactions with contaminants, the presence of excess API, contamination with poisonous substances or allergic reactions to contaminants or substituted excipients.”
Patient exposure to substandard drugs is more prevalent in developing countries, with only an estimated less than one percent of sales in developed countries with strong regulatory agencies like the FDA.
For the patient who depends upon life-saving medications, it becomes imperative to be aware of potential issues that arise when their medication becomes available in a generic form, and to arm themselves with the information and resources to make informed decisions.
In the next article in this series, strategies for navigating the change to generics and how to advocate for access to brand name medications will be discussed.
FDA – http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm144456.htm
Bernstein, Linda, Generic Drugs: Answers to Common Questions, WebMD.com, http://www.webmd.com/healthy-aging/guide/generic-drugs-answers-to-common-questions?page=2
FDA – http://www.fda.gov/Drugs/DrugSafety/ucm169898.htm
“What To Do About the Deadly Threat of Substandard Drugs,” Forbes.com, 06/03/2014.