Generic Drugs Not Always the Same as Name Brand
Generic drugs often seem like the perfect choice: they allow the patient to get their medication for a fraction of the cost compared to name brand alternatives. However, what you might not realize is that generic drugs aren’t always the same as name brand drugs. This is largely because the Food and Drug Administration requires generic drug manufacturers to include the same labeling on their products as that on the name brand version, even if the generic manufacturer knows the labeling to be out of date or incorrect. Furthermore, not all generic drugs are made equal to the name brand counterparts. Clearly, this could spell big problems for patients whose medication is a matter of life or death.
Food and Drug Administration Proposes Change to Labeling Rules
Currently, generic drugs account for over 80% of drugs prescribed today. More generic drugs may be manufactured overseas, in places such as India or China, where the FDA’s oversight does not reach. Consequently, the FDA is proposing to require generic manufacturers to immediately update labels to reflect the latest safety information on a drug. The other problem, however, is that patients have no legal recourse if they are injured or killed as a result of taking a faulty generic drug, thanks to a recent U.S. Supreme Court decision. On the other hand, if a patient takes a more expensive name brand drug, then their legal recourse is preserved.
Advocates Step Up for Patients
Advocates from the Center for Justice & Democracy are stepping up for patients’ rights, especially because patients don’t always have a choice between a name brand or generic prescription drug. Commonly, the doctor decides which to prescribe, leaving patients vulnerable to both doctors’ decisions and the generic drug industry’s lack of oversight. The Center is happy that the FDA has made some steps in the right direction as far as the safety of generic drug labeling, but much more needs to occur before patients are fully protected–including the ability to seek legal recourse if they harmed by a generic drug.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.