What’s In A Name?
Everyone loves a bargain. So it’s no wonder that eight of 10 prescriptions filled in the United States each year are for generic drugs, which are almost always less expensive than the “brand” names. But are consumers compromising quality and safety by being budget shoppers? The short answer is no, according to the Food and Drug Administration, which approves and regulates both brand names and their generic counterparts.
“When the FDA approves a generic drug, it is expected to be substitutable for the reference listed drug,” Kristofer Baumgartner, an FDA spokesperson, said. Generic drugs are, in essence, copies of the brand name.
Any company seeking FDA approval to manufacture and sell a generic drug must demonstrate the medical equivalency of its generic to the original "innovator" drug. To this end, the FDA requires that a generic drug must:
- Have the same active ingredients and be prescribed for the same conditions as the brand name drug.
- Have the same "dosage form" and "route of administration" as the brand name drug, meaning that if the brand name is a tablet taken orally, so too must the generic.
- Meet the same "batch requirements" for purity and quality, and be manufactured, packaged and tested under the same FDA good manufacturing practice regulations that apply to brand name drugs.
“The big message is that generics will almost always suit your needs,” said Charles Daniels, PhD
, professor and associate dean for Professional Practice, Skaggs School of Pharmacy and Pharmaceutical Sciences at UC San Diego.
“There are only a couple of exceptions,” he said. “One is for drugs that have a narrow therapeutic index,” meaning that very small changes in the amount of drug entering the bloodstream or how it is metabolized can have a disproportionate effect in the body.
“If you are on a seizure medication, cardiac medication or blood thinner and it is working, you don’t want to change manufacturers, whether it’s a generic or brand name,” he said.
Another caveat is if you have allergies to dyes or fillers that may be in one formulation but not another. Again, this is not an issue of generics being better or worse than brand names, but of not rocking the boat if something is working for you, said Daniels. “Normally, your pharmacist can help you identify these issues.”
Of course, the reason consumers flock to generics is price, and here generics win hands down. On average, a generic drug costs about 75 percent less than a brand name, according the U.S. Government Accountability Office.
The main advantage of a brand name drug is that it offers consumers early access to newly developed pharmaceuticals. Every drug is born with a brand or trade name. Generics only become available after the innovator drug’s period of market exclusivity and patent protection ends. Yet even here, there is ongoing debate about the value of new drugs. “Just because a drug is new doesn’t mean it is better,” Daniels said.
A new reformulation may mean that a drug is taken once a day instead of twice a day. “This kind of minor modification may make no significant difference to most consumers, but the consumer is confronted with a choice,” he said.
The safety of new drugs is also an issue. When a new drug is approved, its safety is based on outcomes from a relatively small number of patients. “Side-effects that were rare or non-existent in trials may surface when millions of people starting taking the drug,” he said.
The anti-inflammatory drug Vioxx (rofecoxib) is an example of a drug withdrawn from the U.S. market due to safety concerns that emerged five years after the drug came onto the market.
“From a safety perspective, we know a lot more about drugs that have been in use for 20 years,” he said.
Consumers who prefer to purchase drugs via the Internet should keep a couple of other things in mind. The lure of bargain-basement prices online may take you into dark, unregulated corners of the Internet. It’s easier to get scammed because it’s harder to accurately assess the source of the drugs. Daniels recommends purchasing only from recognized retail outlets.
The National Association of Boards of Pharmacy can also help you “spot a rogue site.”