View more...
The Good and Bad of Generic Drugs
The definition of a generic drug, from the U.S. Food and Drug Administration (FDA), is a product that is identical, or bioequivalent, to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Generic drugs are chemically identical to their branded counterparts, but they are typically sold at substantially lower prices. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Billions more are saved when hospitals use generics.
Generic drugs must pass rigorous controls, just like the innovative drug originally created. There is no loss in quality, strength, purity and stability of the generic drug. However, patients may have the perception that a generic drug is not as effective as the original brand name.

Multiplicity, Columbia Pictures
So, let’s take a look at some facts and evaluate what is known about generic drugs as well as brand name drugs.
The development of a new drug is a very complex process, which involves not just the research and development of the chemical, but also clinical trials and all of the regulatory processes to get the drug approved for human use. The cost of this process has been estimated to be as much as $800 million. Such an investment needs to be recovered and there needs to be sufficient margin for pharmaceutical companies to re-invest in more research and development, and keep the wheels rolling in biomedical applied research.
However, there is no doubt that alternatives to these high cost therapies are needed, regardless of how much effort or investment goes into developing a drug. Some countries or individuals simply cannot afford to pay such a high price. Thus, since the approval of the Drug Price Competition and Patent Term Restoration Act in 1984 (USA), generics have opened the doors to those with less resources. It is also helping to reduce health care costs in developed countries.
Now from the FDA perspective, here are some important facts that support the use of generics:
  1. FDA requires generic drugs to have the same quality and performance as brand name drugs.
  2. Research shows that generics work just as well as brand name drugs.
  3. When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is 80% to 85% lower than the brand name product.
  4. Cheaper does not mean lower quality.
  5. FDA closely monitors adverse events reports for generic drugs.
  6. FDA is actively engaged in making all regulated products – including generic drugs – safer.
However, it is a challenging task for watchdogs like the FDA to guarantee the performance of the generic drugs. So let’s look at the other side. In other words, are generics actually identical to the brand drugs?
  1. The FDA requires that you get between 80% to 125% of the brand name drug activity from a generic medication, compared to the original drug. There is more variability added if you get your generic from different vendors, as one may pack 80% of “effective” drug and another one 120%, for example.
  2. Components other than active ingredients are not required to be identical and the formulation could potentially affect how the drug is delivered to your blood stream.
  3. Regarding the controls, the FDA admitted that some generics had not been tested, and even pulled one out from the market.
So what can you do if you feel your body is not responding in the same way to the brand name drug and the generic ones?
  1. Find out if an “authorized” generic exists for your drug. These are generics typically made by the same manufacturer of the brand name medication but sold under a generic brand name. They are not similar, but identical. Ask your pharmacist if one exists for your medication.
  2. When switching to a generic, monitor your condition carefully. When switching from a brand name to a generic drug, or from one generic to another, note any changes you feel and tell your doctor immediately.
Finally, and more importantly, always consult your doctor regarding any questions you have regarding generic and brand name drugs. Always make an informed decision with the help of your health care provider. The points expressed in this post are just factual and for the only purpose of promoting a healthy debate (with the emphasis on healthy when talking about drugs).
Doctor Who, BBC
If you want to know more, you can take a look at these websites:
  1. Generic Drugs: Questions and Answers from the FDA
  2. Generic Drugs, World Health Organization (WHO)
  3. Generic Drugs on Wikipedia

You can give us your comments too:

Contributed by Miguel Tam, Ph.D.
View more...
Forgot your password? Reset Password
Request an Account