Generic Drugs vs. Brand Name: Which is Better?
Tell me if this sounds familiar. You are prescribed a drug by your doctor and drop it off at the pharmacy. Hours later you go to pick up the prescription only to find that you were given the generic kind instead. The pharmacist explains that it’s the same drug and that it’s cheaper, so you pay for the prescription and don’t think twice about it again. The problem is that drug may not be the exact same – even though it should be by law – and worse, even though it may cost you less money initially, it could cost you more money, injury or even death later.
Right now, generic drugs make up more than 80 percent of America’s drug supply. So if the above scenario doesn’t sound familiar, it doesn’t mean you’ve never been prescribed a generic brand before. You may have just never noticed. Legally pharmacists are not required to notify patients or their physician if they swapped out a drug for the generic. This federal law was established in the early 80s under the Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act.
According to FoxNews.com, “the Hatch-Waxman Act conceives brand named drugs and generics as ‘bioequivalent’ meaning they work the same and serve the exact same medical function.” In reality, however, these drugs may have significant chemical differences. Often times, this could be due to poor generic production. For instance, India has emerged as a major manufacturer of generic drugs in America. However, when drugs are created in different countries it comes at a higher risk. India suffers from lax quality control and regulatory enforcement. Some companies simply do not abide by the rules. As a result, several major Indian drug firms have issued huge drug recalls out of quality concerns.
Even subtle changes in a drug can alter a patient’s reaction entirely. For example, the popular generic anti-depressant Budeprion underwent an investigation in 2007 when hundreds of patients reported a relapse of depression, headaches, anxiety, and more serious mental health problems. The investigation found that Budeprion released its active ingredient faster than the brand name, leaving patients unmedicated several hours after taking the drug.
One generic immunosuppressant called SandCya had to be recalled because its therapeutic effects were disrupted when a patient consumed apple juice. This was especially problematic because apple juice is a popular method for administering the drug to children. Research has shown that active ingredients between generic and brand name immunosuppressants – drug classes frequently used by organ transplant recipients – can vary up to 25 percent.
To make matters worse, if you fall victim to a serious injury or death due to a generic drugs, you may not be protected. The Supreme Court ruled that generic drug manufacturers could not be sued by patients who claim that drugs they were defectively designed. According to the NYTimes.com, “the 5-to-4 decision overturned the verdict of a New Hampshire jury that awarded $21 million to Karen Bartlett, a woman who developed a debilitating skin disease after taking a generic version of the pain medication sulindac.” Karen lost nearly two-thirds of her skin, was placed in a medically induced coma, and is legally blind after suffering a reaction to the medication she took for a sore shoulder. Although the court sympathized, they found that because the drug manufacturer, the Mutual Pharmaceutical Company, was required by law to copy the brand-name drug, Clinoril, they could not be held accountable for claims that the drug was unsafe.
This isn’t the first time this has happened. In 2011, Pliva v. Mensing made headlines after the court found that generic drug makers could not be held liable for failing to warn about a drug’s dangers because they are required to use the same safety label as the brand-name version. Although generic drug makers have a responsibility to mirror the safety label of a brand-name company, they are supposed to alert the FDA whenever they learn of an adverse event related to their products. However, even then, it’s up to the agency to decide whether to change the label.
So the question remains: should you buy the generic drugs or the brand name? With all of the above in mind, we recommend buying brand name whenever possible. It may cost you a bit more up front, but until laws are put in place to protect patients from the above issues, it’s the best way to protect yourself.
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