Generic versus name brand…does it make a difference?

  • By Shelly Webb
  • April 27, 2010
  • 504
                        
For years you’ve probably been asked the same question by your pharmacist, “Is generic OK?” And with the high cost of prescription medication in the news, you may wonder how can generic drugs be as effective as name brand when they cost so much less? According to local pharmacist Mark Stutzman of Pomerene Hospital, the answer is pretty simple. “Generic drugs are regulated by law and must meet the same standards as far as the medication itself as well as the availability of the medication in the body, as compared to the name brand medication,” he said. “All these standards need to be submitted to the Food and Drug Administration (FDA) for approval prior to the generic company selling their product. The only differences that are permitted in a generic drug are the inactive ingredients such as color, shape, flavoring, etc.” Stutzman said the chemical structure between generic and name brand medications are exactly the same; therefore, generic drugs will perform exactly as the name brand drug. Normally generic drugs are a lot less expensive than name brand medications; however, some generics are just as expensive as the name brand drugs. “Not all generics are cheap,” Stutzman said. “They are cheaper than the brand name counterpart because of those initial years of research and development that the brand name companies have to put into their products.” According to Stutzman, if a drug company feels that a certain chemical structure they have developed has the potential to make it into the medication market, they will patent that specific compound. After the patent goes into effect, the drug company has 17 years to exclusively hold the patent on that particular compound. “During that time, the compound will go through rigorous testing to determine if it can handle temperature changes, has a long expiration date, can handle compression into a tablet, can be dissolved and so forth,” Stutzman explained. “If the compound passes all that testing, then it goes into years of animal testing to determine if it is effective, if it is toxic, if it has side effects, if it interacts with other medication and how it’s broken down by the system. If it passes this phase, then it will go to human trials, which may take several years as well. So once a drug becomes available to the consumer, the company may have invested up to 10 years and millions of research dollars.” After that much time and expense, the truth of the matter is that the enormous amount of money invested has to be recouped in some form or way. In addition to the millions of dollars spent on compounds that actually become marketable medications, there are many that make it through the animal testing stage only to have serious problems in the human trials. “In these cases, all those years of research is wasted,” Stutzman said. “There are many chemicals that have promising results during phase one, but then the tablet may end up being too big for swallowing and therefore, the research can’t continue. Also there is a lot of dollars spent on marketing a product once it becomes available to the consumer. For instance, simply turn on the TV, and you’ll see lots of advertisements for medications.” Stutzman said that in today’s health care market, prescription medications are more consumer-driven than ever before. Since the drug companies know this, they will spend a lot of money targeting the consumer instead of the physician. “Generic companies, on the other hand, do not direct their spending toward the consumer,” Stutzman added. “Since a drug that has made it through all the phases already has a proven record as a brand name product, then the generic companies save a great deal of resources.” Another plus for generic companies is that very few generic companies invent (or patent) new drugs. Unfortunately, drugs and medications are a big business, and making a profit is a huge consideration for any company. Because of this, new medications aren’t always created as quickly as needed. “There are fewer and fewer new medications entering the market,” Stutzman said. “Research costs are skyrocketing and the companies are becoming much more selective about what products they will bring to the market. There are also fewer pharmaceutical companies as well and companies are buying other companies, which produces fewer players in the market. Without that support, we will see a continuing decline in new research. It’s kind of a Catch-22. We need the new medications, yet can we afford it?” One important fact consumers need to remember when it comes to the high cost of medications is that without money, no new drugs will be invented. Drug companies are in the business to prosper. Saving lives in the process is wonderful---but quarterly profits and stock prices dictate a lot of the research and fund availability.


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