By Joe Graedon, The People’s Pharmacy
Few health professionals are familiar with the concept of authorized generic drugs, and people receiving treatment are even less aware of this category of medications. That’s because most people have only heard of brand name medicines or their less expensive generic counterparts. But authorized generic medications represent a valuable option, especially for mental health conditions.
Let’s take a look at three different types of medicine.
Brand Name Drugs
A brand name drug is when a pharmaceutical company develops a unique compound called an active pharmaceutical ingredient (API). The manufacturer patents that product along with the process that will turn it into a pill, patch, spray, ointment or injectable. Once the clinical trials are completed that prove to the Food and Drug Administration (FDA)’s satisfaction that the drug is “safe and effective,” the company has a finite period of time to market that medicine exclusively with no competition.
Once the patent runs out on a brand name medicine, generic drug manufacturers can create a copycat version, but they have to do this through reverse engineering. That’s because brand name companies do not have to reveal their “secret sauce” with generic drug companies. Once a company has developed a version to mirror the brand name product, it must be tested against the original brand name drug. If the generic company can demonstrate “bioequivalence,” the FDA grants approval. Bioequivalence means that the generic medication gets into the bloodstream in a similar manner to the original brand name medication.
Authorized Generic Drugs
The third category of medications that has remained under the radar for many people is authorized generic (AG) drugs. When the brand name company loses its patent on the active pharmaceutical ingredient, it can still keep the manufacturing process a secret, just as the Coca-Cola company carefully guards its own special recipe. In some cases, the brand name company makes the authorized generic on its own production lines with its original ingredients and process. In other cases, it provides the recipe to another company so that the resulting product is in fact a faithful copy of the original, but it is still considered to be an authorized generic version of the drug.
Why Should You Care About Authorized Generics?
Finding the right medication at the right dose to control mental health symptoms can be a long and difficult journey, but can often drastically improve quality of life as part of a treatment plan. While not all people will start with a brand name medication, many will, but costs can become an issue. When costs become an issue, one of the first steps typically taken is to switch to a generic version of a medication. While plenty of people will have no problem switching to a generic, others may notice that it doesn’t work as well or in some cases can experience side effects or reactions to the different ingredients (like dyes and fillers) used in generic medications.
A woman named Kimberly reached out to The People’s Pharmacy to share her dilemma:
“I have been taking [a generic benzodiazepine medication] for over two years and they had always been green. A few months back, the pharmacy started giving me blue pills. They don’t work like the others and trigger my migraines. I just found out they have corn as a filler, and I am sensitive to corn! Now what do I do?”
If available, an authorized generic drug can make treatment more affordable while avoiding adverse effects or reduced effectiveness for people who have trouble with generics. My organization, The People’s Pharmacy, has heard from many individuals over the last decade that has raised concerns about generic drugs, especially in the field of mental health, so we feel it is important to raise awareness about authorized generics.
What Can Consumers Do?
- If you detect differences in your reaction between a brand and generic medication, or even different types of generics for the same medication, let both your prescriber and the pharmacy know.
- Get informed. Find out if your medications are available as authorized generics at www.authorizedgenericmedicines.org.
- When possible, ask both the doctor and the pharmacy for your prescription to be filled with an authorized generic (it should cost the same as a generic). Your doctor can specify a particular manufacturer.
- If you experience a serious adverse event, product quality problem, or difference between how medications that are supposed to be “the same” are working, let the FDA know. You can report problems through the FDA’s MedWatch program at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and website (www.PeoplesPharmacy.com). In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”