Is is there really a difference between brand-name drugs and their generic counterparts?
This is a common question that many of us ask ourselves when standing at the pharmacy comparing Nyquil to its CVS counterpart. We all have different answers. Some of us prefer the cheaper generic, others only trust the brand-name original.
For several years, the Food and Drug Administration (FDA) has claimed that there is no difference between the two. This has been a relief to many of us who stand to save A LOT of money from buying generic drugs. According to the FDA, in 2010 the use of FDA-approved generic drugs saved $158 billion, an average of $3 billion every week. This has also been a huge relief to insurance companies, that will typically authorize prescriptions of generic drugs, rather than brand-name, to injured workers, and those injured due to medical errors or automobile accidents.
However, a newly published article by the NY Times shows that the FDA is beginning to look more closely at generic extended-release drugs. The FDA’s change of course occurred after a generic antidepressant, a 300-milligram dose of bupropion, was met with complaints from patients whose depression had returned. The companies that were marketing the drug stopped selling it.
The FDA’s decision to more closely inspect the techniques generic drug manufacturers use to make extended-release drugs has added to the ongoing debate between pro-generic and anti-generic supporters. Critics of generics say the FDA and generic drug companies have been reluctant to admit that generics don’t always work as well as the brand-name originals. Meanwhile, pro-generic supporters dismiss such arguments, saying that recent disapproval is just the latest effort in a broader movement to unfairly discredit generics.
Specifically generic extended-release drugs are under scrutiny because they are trickier to make than other types of drugs. Although the active ingredient in the generic drug is the same as the brand name original, the mechanism for gradually releasing the drug into the body can vary.
And brand-name companies not only patent the drug itself, but the way the pill releases the drug. The method’s patent can often outlast the patent for the drug itself. So when the brand-name drug loses its patent protection, generic companies will make their own extended-release version of the drug, using a different method so they won’t infringe on the other company’s patent.
Some generic drug critics say that generic companies don’t always effectively mimic the brand name drug’s effect and that the FDA doesn’t adequately evaluate the effectiveness of the generic in comparison to the brand-name drug.
Dr. Harry M Lever, a cardiologist at the Cleveland Clinic, says that although he’s not against generic drugs, if his patients are stable on whatever they’re taking, they shouldn’t let the pharmacy change it.
The bottom line: Sometimes generic drugs work as effectively as brand-name drugs, sometimes they don’t. If a certain type of drug is working for you, whether it is generic or brand-name, stick with it. Don’t let the pharmacy or insurance company change it.