New Thoughts on Drug Safety Prompted by Court Ruling

When a drug is tested and approved for use by the FDA, we often take for granted its safety. Obviously this is not the case, as we have seen with many approved drugs causing harm, COX-2 Inhibitors like Vioxx being an example. Although we often turn to medicines to fix our problems (and it’s great when they do!), we need to keep in mind that these are foreign substances that make significant changes to our bodies. Sometimes these are good, sometimes not so good. Usually it’s a combination of the two.

An interesting ruling was made on a case in San Francisco last week, involving the safety of medications. What made this case so unique is that the court ruled that drug makers could be held liable for harm when a generic version of their name-brand product is used. Obviously, the drug companies are not happy about this and it’s easy to see why. They are not manufacturing the product; they have no control of the product that is produced by other companies.

However, I see where the court is coming from on this one. Let’s say you’re taking a drug for the long term and, barring any manufacturing mistakes, the drug harms you in some way. What’s most likely is that your doctor prescribed you the name brand and, due to dispensing laws, the pharmacist filled a generic version of that drug for you. Your doctor prescribes that drug, name-brand or generic, with certain results in mind. Pharmacists fill the prescription with the generic because it’s the same product, possibly with different inactive ingredients. The effects of the generic should exactly mimic that of the name-brand.

So, in a sense, I can see why the ruling was what it was. The drug company had to prove safety and effectiveness in order to get the drug approved. The manufacturer of the generic drug did not. They are producing the drug in accordance with the name-brand standards. So when the drug harms somebody, the scrutiny goes back to the clinical trials and safety that was proven or missed in the research.

I don’t think that the manufacturers of generics should be completely dismissed in these cases. They are producing products to make themselves money. Whether they are manufacturing the drugs based on faith of their effectiveness and safety or not, they should still be held liable for the effects of the product on people.

My question is this. Did Wyeth warn of the safety concerns of taking the mentioned drug for long periods of time, even just for the name-brand? It seems like if this were the case, they shouldn’t be held liable. The generic manufacturers should know of the side-effects and use warnings as well. In this case, I could not fault the drug company for the mistake of the generic manufacturer. In cases where it is not publicized, that is less clear and needs further scrutinizing.