Prescription drugs: generic vs. brand name

80% of all drugs dispensed in the US are generic equivalents of a brand name. But are they really equivalent?

By law, a generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used. The FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.

Generic drugs cost less than brand name drugs – up to 80% less. Many private health plans charge a lower co-pay for a generic.

So what are the reasons not to use generics? There are 2 that I know of:

1. If you have an adverse event or a bad reaction causing damages because of the drug, you can’t sue a manufacturer of generic drugs. The FDA and the brand name drug company work out the drug label (how and when to take the drug and what the risks are for taking it). The generic is required by law to distribute that label without changes (except for the the name). Since they don’t have the option of adding newly discovered side or long-term effects, they have no liability. They also have no incentive to seek out problems with the drug to report and correct.

The New York Times had a heart-breaking story that compared 2 women who were both given a drug that caused gangrene and the loss of a hand. One sued the manufacturer and received compensation. The other, given a generic version of the same drug, received nothing.

Drugs designed and approved for long-term use are only tested for short-term side effects. Using a drug daily or monthly for years might have a significantly different set of effects over time (like statins). Some drugs taken for a short time period might have an effect that isn’t apparent until years later. That is why we created this website, to gather what information we can find on such unanticipated outcomes.

2. There is a risk of manufacturing impurity. The FDA inspects a percent of all manufacturing facilities each year for quality. However, those facilities not within the US are much less likely to get inspected. There have been several stories lately, and a recall by the FDA, on generic drugs manufactured outside of the US that were not what they purported to be or as sanitary as required.

I have one of those plans that have a lower co-pay if I use the generic. I believe that the generic is exactly the same as the brand name. However, I am going to demand the brand name from now on. Such a shame. There is absolutely no difference, except responsibility.

Suzanne B. Robotti

Suzanne Robotti founded MedShadow Foundation in 2012. Learn more about Su and her mission.

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