The Truth About Generic Drugs
(BlackDoctor.org) — The myths and misunderstandings surrounding generic medications have long fueled allegations of ineffectiveness, inferiority to brand-name drugs, and unnecessarily increased costs for people who need to take those medications.
What Are The Similarities Between Brand Name & Generic Drugs?
Same Active Ingredients. The simple truth is that when a generic drug product is approved, it has to prove that it meets the rigorous standards established by the United States Food and Drug Administration (FDA) for drug identity, strength, quality, purity and potency. That means that generic drugs must have the same active ingredient, strength, dosage form, and route of administration as the brand name product.
Similar Blood Levels. A generic drug must be shown to give blood levels that are very similar to those of the brand-name product. If blood levels are the same, the FDA assumes that the therapeutic effect will be the same as well. Because of the similarity, the generic drug will not need to undergo additional clinical studies to prove effectiveness, and the FDA can provide assurance that the generic product will perform the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release.
Same Quality Standards. The sites where generic medications are manufactured, tested, and packaged must also pass the same quality standards and specifications as those of brand name drugs. Many people are unaware of the fact that many generic drugs are made in the same plants as innovator brand name drug products.
What Are The Differences Between Brand Name & Generic Drugs?
Different Inactive Ingredients. Generic drugs do not need to contain the same inactive ingredients as the brand product, so the coloring, flavoring, or ingredients used to hold tablets together may also be different. In additiona, some variability can and does occur during mass drug production, for both brand name and generic drugs, so limited and very small variations in purity, size and other parameters are allowed.
Reduced Price. One of the most noticeable differences between brand and generic medications are their prices. Generic medications are not typically cheaper than brand name drugs because they are inferior or don’t work as well; rather, the difference is due to the drug development process. Developing a new drug can potentially cost many millions of dollars and take up to 15 years or more to create. The FDA allows these innovator companies to receive patents on the drugs that they create.
The multi-year patents prevent other drug companies from copying the drug and creating their own version. This practice gives the innovator companies time to recoup the costs they incurred in the development, testing, and marketing stages without interference from other companies attempting to share in sales of the medication. When the patent expires, other companies are free to copy and produce their own generic version of the drug. The generic products compete with the brand name by offering lower prices because they do not have to try and recover monies spent for research, advertising, marketing, or promotion of their drugs.
Are Generic Drugs For You?
There are many generic drug solutions available that are cost-effective and equivalent to brand name medications. Debunking misconceptions about generic medications can help both patients and healthcare practitioners make more informed decisions about drug therapy, so talk to your pharmacist or physician to see if generic medications are right for you.
By Dr. Crystal Riley, BDO Pharmacy Expert
A graduate of the Howard University School of Pharmacy, Dr. Crystal A. Riley has spent the majority of her career involved in drug information services for not only healthcare organizations and practitioners, practitioners, but for patients as well. While her career has shifted towards researching healthcare policy and quality standards, Dr. Riley still actively seeks opportunities to keep patients informed and aware of medication-related issues to help improve their overall quality of life.