Generic Drugs: Are They Safe and Effective? Part One

– Posted in: Medications

The 1980’s and 90’s saw a boom in the development of psychiatric medications. The 20-year limit on their exclusive patents are now expiring, and more and more generic versions of these drugs are becoming available.

Generic drugs are almost always cheaper than their brand name counterparts, so insurance companies insist on dispensing generics whenever possible.

The public is confused and suspicious of the generic drugs being pushed on them by their insurers. Are these medications as effective and safe as the brand names? Do they introduce new side effects?

This article is the first of a two-part series written to provide you with answers. This part will give you a quick overview of generic drugs: What they are, how they are certified by the U.S. Food and Drug Administration (FDA) and how to identify them. The section headings are:

  • What is a generic drug?
  • How is a generic drug certified by the FDA?
  • How can I tell if my medication is generic?

Be sure to read Part Two of this series!
Part Two covers some of the most important issues and questions about generic drugs under the following headings:
    • Issues: Are generic and brand name drugs identical?
    • Issues: What about generics’ effectiveness?
    • Issues: What about generics’ side effects?
    • Issues: Generic drug labels don’t have to be updated
    • Issues: Doctors’ attitudes toward generic drugs

What is a generic drug?

Generic drugs are FDA certified equivalents of brand name drugs

The U.S. Food and Drug Administration (FDA) regulates and certifies all drugs prescribed by physicians in the United States, including generic drugs.

The FDA certification requirements for a new drug are quite stringent. It must pass a number of strictly defined and carefully controlled clinical tests showing its effectiveness and safety. Thousands of pages of documentation are mandated.

It is very expensive to develop a new drug and get FDA certification. So the FDA grants a patent to the drug company, giving them the right to market the new drug for twenty years without competition.

When a drug’s patent runs out, other companies can submit medications to the FDA for certification as the equivalent of the brand name drug. These drugs are called “generics” and may be substituted for a brand name drug by doctors and pharmacists.

Generics cost less than brand name drugs, since there is little research and development or marketing costs involved in their manufacture and sales. Insurance companies usually require the use of generics unless there is a medically valid reason to use the brand name drug.

How is a generic drug certified by the FDA?

A generic drug’s chemical must work the same way as the brand name’s

The FDA sets up many hurdles for drug makers of generics to jump on the way to certification as equivalent to a brand name drug. The main questions that have to be answered are: {{1}} {{2}}

  • Does it have the same active ingredient working in the same way?
  • Does it have the same strength for a given dosage?
  • Does the body absorb and use the drug in the same way at the same rate?
  • Is the dosage form and way it’s administered the same?

Drugs that pass these tests are termed “therapeutically equivalent” and certified as a generic substitute for the brand name drug.

How can I tell if my medication is generic?

Brand name drugs are labeled by their names – generics by their chemicals

You can spot a generic drug by its label: The active chemical’s name is written prominently instead of the brand name.

The brand name it substitutes for is in smaller letters, usually below the chemical name. The generic’s manufacturer name will be in small type somewhere on the bottle.

On a brand name drug, its name and dosage is printed below your name. The manufacturer’s name is usually right under the brand name. For example:

Generic and Brand Name Drug Labels

A generic drug is required to look different from the brand name drug. So if the brand name pill is a blue triangle, the generic drug might be a yellow circle. Look for the pill color and other identifying marks on the labels of both generic and brand name drugs.

The way a generic drug is administered must be the same as the brand name. For example, if the brand name medication is a pill, the generic must be a pill, too – it cannot be a capsule.

What do you think?

I often express gratitude that I’m dealing with my mental illnesses in the 21st century and not in the 1970’s or 1950’s or – horrors! – the 1400’s.

There have been great strides made in psychiatric medication over the past twenty years. Fortunately, some of the old “tried and true” drugs like Wellbutrin® and Paxil® still help many people and have been around long enough to have cheaper generic versions.

But we’re all different physically and mentally. The bottom line with psychiatric medication is that any given drug will work differently in every person. The same is true for generic versions of brand name pills.

I’ve only scratched the surface on the subject of generic drugs. Let me know if you would like more articles about them.

Be sure to read Part Two of this series!
Part Two covers some of the most important issues and questions about generic drugs under the following headings:
    • Issues: Are generic and brand name drugs identical?
    • Issues: What about generics’ effectiveness?
    • Issues: What about generics’ side effects?
    • Issues: Generic drug labels don’t have to be updated
    • Issues: Doctors’ attitudes toward generic drugs

As always, your comments are welcome! If you have enjoyed this post, please consider subscribing to this blog, either via RSS or email at the top of your screen. It’s free! You can also follow me on Twitter from the same place. I would also appreciate your sharing this post using your favorite social media, such as Reddit, Tumblr, and StumbleUpon. Just click the little green “ShareThis” button at the bottom of this post.

PLEASE NOTE: The contents of this article are provided for informational purposes only. The author is not a trained or licensed medical professional and has based the article on authoritative information from outside sources as given in the footnotes. This article is not intended as a substitute for advice from a trained and licensed medical professional.

Last updated: May 18, 2012

[[1]]Nightengale, Stuart L. Therapeutic Equivalence of Generic Drugs – Letter to Health Practitioners. January 28, 1998. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm073182.htm. Accessed 4/26/12. [[1]]
[[2]]Lowers, Jane; Howland, Robert H. Generic vs Branded Psychiatric Medications: Is There a Difference? Medscape website: http://www.medscape.com/viewarticle/762343. Section 1. Accessed 4/25/12 [[2]]

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5 Comments… add one
pregnancy miracle ebook June 20, 2012, 7:09 pm

I’m now not positive where you are getting your info, however good topic. I needs to spend a while studying more or understanding more. Thank you for wonderful info I was in search of this information for my mission.

Michel
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August 28, 2012, 1:48 am

Generic drug is much safer than any other medicines.FDA regiser a all medicine including generic drugs.these drugs are prescribe from a health specialist in U.S.

James March 23, 2013, 5:54 am

For me generic drugs are safe as long as the company who made it is approved by FDA. You can have great savings using generics medication. Thanks for sharing this.
James recently posted…Converting Web Visitors Into New Patients – The Who in Google AnalyticsMy Profile

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