Generic vs Brand Name - Is There a Difference?

I've always been a big fan of generic drugs. They have the exact same active ingredients as brand name drugs and are normally much less expensive. Of the six billion prescriptions written in the US every year (that's 18 for every man woman and child in the country), 90% are filled with generic drugs. The FDA assures us that they are as safe and effective as their brand name doppelgangers. And for most people, most of the time, for most generics, they are. Mostly.

There are four issues that you may want to consider when opting for a generic.

1. Generic drug manufacturers often have less stringent quality control processes. Generics are often much cheaper, of course, but that means much thinner profit margins for the manufacturer. Leaving them less money to spend on frills like quality control. The FDA does inspect these manufacturers now and then, and mostly they meet the GMP standard. Mostly.

2. Instant vs timed-release formulations. Forty years ago nearly all prescription drugs were "instant release", their active ingredient was released immediately into the bloodstream. By the mid-1980s, pharmaceutical companies began to market "time-release" formulations that released the active ingredient over long periods of time. This allowed people to take just one dose per day instead of needing to take more every few hours. The FDA process for approving generic drugs is based on a "maximal concentration" standard. That is, the highest concentration produced by a single dose. This will be exactly the same or better for a generic compared to its brand name equivalent. But the hour by hours level of a generic drug in the blood may be very different, potentially reducing its effectiveness and increasing side effects.

3. Foreign manufacturing. About 80% of the active ingredients used in generic drugs are now made in foreign countries, including India, China, Thailand, Mexico, Turkey and Brazil. Many generic pills are manufactured abroad in their entirety. The FDA is severely limited in its ability to oversee these manufacturers. In the US, the FDA can simply show up at your door unannounced and inspect your facilities. Abroad, the FDA must schedule their visits in advance, giving manufacturers days or even weeks to prepare. Some of the issues this has lead to include low levels of the active ingredient, contamination and falsification of test reports. Again, most foreign manufacturers are honest and reliable. Most.

4. Transportation. Within the US, the FDA sets stringent requirements for the conditions under which a drug may be shipped. Storage, temperature, packaging and so on. It does not have this authority outside of the US. So a not uncommon scenario might be an active ingredient is made in China, shipped to India to be formulated into pills, then sent to Houston by container ship, trucked to a wholesaler in Phoenix  and finally distributed to pharmacies. No one can really say how this might affect the drug when you finally take it. Mostly you will be fine. Mostly.

If you are going to use generic drugs, and your insurance company will be pressuring you to do just that, there is little you can do to protect yourself from these issues. There are not really any particular categories of generic drugs that are safer or riskier than others. If you are taking a generic drug, make sure to monitor your lab results to ensure that it is having the desired effect. Consider buying the brand name drug from a Canadian pharmacy. This is likely to be somewhat more expensive, but it is perfectly legal. Be aware of whether or not your symptoms are responding as expected. Get the name of the manufacturer of your specific drug from your pharmacist. If you have any problems, try to get the same drug from a different manufacturer.

In the US, generics are indeed much cheaper than brand name drugs, and mostly they are safe and effective. Mostly. But there is no such thing as a free lunch.