The rising cost of healthcare has left many reeling under the weight. One cost-cutting measure is to buy generic prescription drugs instead of name brand. In fact, many health insurance companies won’t cover brand name when generic is available. Some people have concerns about taking generic drugs. Are they as good? Do they help the same as brand name drugs? If they are the same why do they cost so much less? Why do generic drugs look different from brand name drugs? These are all good questions.
What are Generic Drugs?
In a nutshell, generic drugs are copies of brand name drugs. According to the U.S. Food and Drug Administration (FDA) rules, generic drugs must have the same active ingredients, same dosage requirement, same intended use, effects and side effects as well as the route of administration, risks, safety and strength of the original or brand name drug. This rule applies toCredit: Photo courtesy of National Institutes of Health not only prescription drugs, but also to over-the-counter (OTC) drugs. In addition, trademark laws stipulates the generic drug must look different from the brand name drug.
Firms that manufacture brand name drugs are called “innovator” or “pioneer” companies. These companies spend millions of dollars each year to develop new drugs. The process involves a long testing and approval process. Once the FDA approves the drug, the company gives the drug a brand name and spends millions more in marketing it. When the drug is approved by the FDA the companies subsequently earn a patent which protects the drug from competition. The patent is usually for a period of ten years. When the patent expires, other companies can apply for FDA approval to manufacture their version of the drug. The major innovator companies do manufacture generic drugs as well as their name brand versions. Between 50-80 percent of all generic drugs are manufactured by the approximately 92 innovator drugs with the rest of the generics manufactured by about 300 small pharmaceutical companies. 
Do Generic Drugs Work as Well as Brand Name Drugs?
FDA inspects all drug-manufacturing facilities and according to the agency the generic companies “in most instances” have equipment and plants which are comparable or in some cases surpass those of the innovator companies. That’s all good and well, but do the drugs they produce work as well?
According to most doctors and other experts, the answer is an emphatic “yes.” Most support their opinion by citing the approval standards of the FDA. Since 1984, manufacturers of generic drugs do not have to carry out clinical trials to establish the safety and efficacy for drugs introduced by innovator companies since 1962. The FDA considers the initial trials adequate demonstration. The generic companies do, however, have to prove to the FDA the formula for its product is correct and uses the same amount of identical active ingredients in the brand name version.
Properly prepared generics will be absorbed into the bloodstream in the same manner as the brand name drug. The FDA requires the company to complete a bioequivalence test study. Generic companies usually complete the study on 20-24 healthy men. Usually, the men are given a single dose of the generic and then technicians take blood samples at timed intervals and determine the amounCredit: Photo courtesy of the National Cancer Institutet of drug in each sample. The values are plotted over time which produces a “bioavailability curve” which describes the absorption into the bloodstream. Later, the same procedure is conducted with the name brand drug. The FDA approves generic drugs if the its bioavailability curve closely matches that of its brand name equivalent. Drugs bioequivalent to others should have the same therapeutic effect. Although innovator companies express concern of the validity of this procedure; they too use it to change inactive ingredients in their own product.
The FDA evaluates the bioequivalence by how much of and how fast the drug is absorbed into the bloodstream. Most pharmacological experts agree the difference of 20 percent or less is not clinically significant for the majority of drugs. If the generic drug is more than 20 percent in either quantity or speed of absorption, the FDA won’t approve it. This allowable difference is called the "plus-or-minus 20 percent rule."
The innovator companies complain the percent is way too high of a variable to make the generic equivalent. They use the hypothetical scenario where a patient takes Generic X with a bioavailability rating of 120 percent; the refill is filled with another version whose bioavailability is 80 percent. While both are acceptable according to the rule; the change is a 40 percent decrease which makes the drug’s effectiveness questionable. The Brand name companies call this scenario "the dangers of indiscriminate interchange." Using this scenario, they can convince physicians to prescribe the brand name over the generic.
According to the FDA, a review in 1986 of all new generics approved since 1984 revealed the calculated difference in bioavailability to be only 3.5 percent. The FDA further stated of the 5000 generic drugs approved, they were not aware of even one documented case any of those had caused treatment problems. Those few drugs which should be monitored when switching formulas include digoxin (Lanoxin), levothyroxine (Synthroid, Levothroid), and warfarin (Coumadin).
So What Fuels the Debate About the Effects of Generic Drugs?
Generic companies lobbied congress to consider legislature making generic drugs more available. Congress responded by passing the Drug Price Competition and Patent Term Restoration Act of 1984. The competition resulted in a huge propaganda campaign by the large innovator companies. Some of the companies sent letters to pharmacists and doctors detailing the possible lawsuits should they prescribe the “less effective” generic drugs. The FDA declared the letters “labeling” and can take action against the company should the letter be false or misleading. However, the FDA has no authority over public interest groups who sent similar letters. Therefore, the innovator companies have routinely funded various events, grants and the like of these public interest groups. According to Peter Rheinstein, M.D. director of the FDA’s office of drug standards, "Every time a brand-name drug becomes vulnerable to generic competition, the makers do whatever they can to protect their market."
The innovators company then took the campaign directly to consumers by advertising their products. Eventually, the FDA dictated ads mentioning product names must include prescribing and precautionary information similar to what is on the package insert. Any ad whether or not the name is mention cannot promote the product as the only available treatment for a condition.
Tales of horror are another tactic used by the innovator companies to dispel the effectiveness of generic drugs. Again, interest groups may have a story to tell and by doing so, they get grants or other funds from the brand name companies. If a consumer actually researched the quoted statistics, it might be a total different story; a “study” may be a limited participant study or a video news release that is actually an advertisement message.
Companies in the prescription drugs business, at least the major companies, usually spend more annually on promotion than they do research. The majority of the promotion money goes to physicians. Physicians were already wary due to recalled generic drugs and illegal generic drugs before the FDA clamped down on the approval process. Still, physicians are subjected to major campaigns from the major drug companies from early on in their careers. The brand name drug companies sponsor conferences, seminars, dinners, luncheons and awards and ensure attendees are entertained. They give away videos and books and audiotapes. Often these are charged to the company’s research and education budgets. In addition, representatives of the companies give a large amount of samples to entice physicians to prescribe the drugs they’re hawking.
Okay, Generic vs Brand Name Drugs: What’s the Bottom Line?
Consumers can be assured the FDA regulates generic drugs to match active ingredients of their brand name counterparts. The issue may come when one looks at the inactive ingredients. Keep in mind the studies are done on only 20-24 males, reportedly “white” males from age 24-55, so it is possible effects could be different for different participant mixes, but to date there is no documentation of such claims according to the FDA.
An estimated 44 percent of all prescriptions in the United States are filled by generic drugs. While the active ingredients are the same in both generic and brand name drugs, the inert ingredients can vary widely. Though the FDA doesn’t allow even inert ingredients to effect the efficacy of the generic drug, there may be problems for some who take a generic such as allergic reactions to coloring, flavoring, or binding used in the generic drug. The inert ingredients may also interact with other medications a person may be taking.
Consumers should be diligent in monitoring their own care in terms of the prescriptions they are given. Read labels, make sure the treating physician knows of any allergies and other medications being taken. Be well informed and in the majority of cases, generic drugs will treat the condition the same as brand name drugs—only cheaper.
The copyright of the article The Prescription Drug Debate: Generic vs Brand Name is owned by Cheryl Weldon and permission to republish in print or online must be granted by the author in writing.
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