Posted on March 11, 2020 at 12:00 PM
Chances are, you've probably consumed a generic drug if you ever had a prescription filled in at a pharmacy. According to the Food and Drug Administration, almost nine out of ten prescriptions filled in the US today are generic drugs.
Yet there are many people who feel uncertain about what they are, where they come from, and when they should be included. Pharmacy Director Mandy Leonard, PharmD, BCPS, addresses some common questions and misconceptions regarding generic medicines to help you stay informed.
When a pharmaceutical company first produces and launches a new drug on the market, the FDA requires the company to be the sole manufacturer and distributor of that medication for a given period of time. It gives the company the opportunity to recover without any pressure the money it spent developing and selling the medication.
Nevertheless, once that period expires, other drug companies can carry copycat versions of that drug (generics) onto the market.
The FDA must approve generic drugs before they can be made available to consumers in the U.S. but they go through a separate approval process than the original brand-name medications.
For areas that don't impact how it actually works, a generic drug can be different from its brand-name equivalent–for example, the medication may be a different color or shape. But the company making the generic drug still needs to show the FDA that the inactive ingredients it uses are safe and that it produces the product using current good manufacturing practices (CGMPs).
The generic drug company demonstrates to the FDA by doing all of these things that their version is "bioequivalent" to the brand name drug. If it does, it doesn't have to replicate lengthy and time-consuming clinical trials performed by the brand-name drug maker to prove the drug is safe and successful.
Once a generic drug is approved and made available, it continues to be regulated by the FDA (as it does with brand name drugs as well). The FDA regularly carries out reviews of manufacturing plants where the drugs are made to ensure compliance with CGMPs.
Also, the generic drug company is required to notify the FDA whether patients are experiencing any serious side effects or harmful reactions to its products.
Just because they cost less does not necessarily mean that the standard of the generic drugs is poorer. Companies can charge less for them because they don't have to spend millions of dollars on clinical trials and selling new drugs like does the brand-name drug's initial creator.
Generics also generate market competition which can further drive down prices.
Most drug companies import ingredients from or produce their products internationally, both brand-name and generic. Those manufacturing plants still have to meet CGMPs, though one of the FDA's regulatory challenges is to keep up with all of those manufacturing plants ' surveillance inspections.
There are generic versions of many drugs available to patients today, but each hospital or health care organization has its own method for assessing and choosing which medications it will deliver.
For eg, just because the FDA accepts a generic drug doesn't mean we're going to be selling it here at Cleveland Clinic. We have a different drug review and approval process, where a panel of experts assesses how safe, efficient and cost-effective they are.
We also have a list of vendors from whom we do not buy, because we know that in the past they have had a price or recall issues, and we have determined that selling them is not worth the risk, even if they are the cheapest option.
You can always apply for brand-name medications, but be mindful that insurance companies also offer generics better coverage because of their lower cost.
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