Generic Drugs: Cheaper, Yes; Same Quality, Maybe Not
Reader Comments
Generic drugs in perspective
Generic drugs offer an important option to the patient and, notably, a number of the most significant drugs developed in the last 20 years are now available in generic form. However, in order to make an informed choice as a patient, we have to understand the standard for approval of a generic drug. Generic manufacturers are able to reference the evidence submitted to the FDA by the branded manufacturer and the continuing evidence of safety during the years that the product has been marketed. In addition, the generic manufacturer must typically demonstrate that when the generic drug is administered to a small group of subjects, the amount of drug measured in the blood stream is similar, or bioequivalent, to the amount of drug measured when the branded drug is administered. There is no requirement that the "exposure" be exactly the same. Relatively similar is acceptable to the FDA. A common standard is the requirement that the exposure after the generic drug falls within 80% to 125% of exposure after the branded drug - for the average subject. Therefore, whether the exposure is 90% (a little lower than before switching) or 110% (a little higher than before switching), as long as we are reasonably certain that the exposure falls between 80-125% then the generic drug can be approved for marketing. The approach is reasonable, economical, and proven to result in effective therapy for the patient population as a whole. However, individual patients should carefully monitor for side effects and the effectiveness of their therapy when switching between branded and generic drugs (or between different forms of the branded drug) because there are several weaknesses in the way that generic drugs are approved. For example, the amount of drug is measured in the blood stream and not measured where the drug actually has its effect. Also, the amount of drug is evaluated by looking at the peak level (Cmax) or levels over time (AUC). While these two evaluations are important, it is possible that two patients with similar Cmax and AUC will have different levels of the drug in their blood stream at a particular time. Lastly, the approval of the generic drug is based on subjects as a whole and not on individuals. Therefore, if you are a patient who needs a little more of a drug for effective treatment then it may matter whether the generic product is delivering 90% or 110% of the drug in the bloodstream. Every patient, in concert with their physician, should monitor the switch from a branded to a generic drug as current bioequivalence standards do not ensure the same therapeutic effect, on an individual basis.
Question for Larry Lee
I am a consumer and would like to know how one researches to find out where the drug is being manufactured. How does one locate a company that manufactures generic meloxicam?
Generic drugs are products just like any other
When you buy a product thats important to you, you dont just go for the cheapest thing you find. You want quality for a reasonable price. Therefore you buy from a company you think makes such products. The same thing should be with generic drugs. Only here, you dont know who made it or where it was made. And dont be fooled, remember: the FDA can not secure that every pill sold in the USA is proper. It is to the largest part up to the manufacturer. And if the manufacturer operates on a lowest cost principle without a tradition of quality standards what can you expect? That he will throw away a faulty batch or that he will "adjust" the documentation and ship the batch to market anyway? To conclude, generics are to the largest part OK if you buy them from the right companies. You have to do the same you usualy do as a consumer: inform yourself about the product your buying and dont buy junk.
meloxicam
My wife started taking Mobic and had good results, Our insurance co. required that we switch to a generic after several months. The first generic, from India caused a rash on her chest. Changed to a second generic, from China caused headaches. After much research found a generic produced in the US from the same company that makes Mobic. This generic caused no rash or headaches. Is there a web site that list US made generics? The fillers for generics made in India and China are not all the same as one produced in the US. Who is regulating what products can go in generics from countries other than the US?
Generic Drugs
Dr. Healy,
It is disheartening when a scientist of your caliber choses to ignore evidence based results and relies instead on inuendo.
In the modern era of generic medications (post Waxman-Hatch and with current bioequivalence standards), has there ever been a scientifically validated, prospective study showing that generic medications are inferior to their branded equivalents? As you know, the branded pharmaceutical industry spends millions of dollars protecting their franchises through patent suits, marketing efforts and reformulations. If they could eliminate generic competition by showing clinical inferiority, they would certainly do so. The FDA has repeatedly evaluated the claim that generics are less effective than branded products and they have found no substantial evidence to support that claim.
You also draw incorrect implications from the unfortunate heparin incident. In today's world both generic and branded pharmaceutical companies source ingredients, including the active ingredients, all over the world. The US distributors of the adulterated heparin were not unknown, foreign manufacturers, but rather the highly regarded US suppliers of brand-name, injectable pharmaceuticals. There is no basis for implicating generic manufacturers because of the experience with adulterated heparin.
Americans deserve safe, affordable medications. The FDA has rightly committed to increased inspection of foreign plants. This will benefit the generic industry, branded pharmaceutical companies and most importantly the American people.
Medical scientists must work together to provide the most, informed appropriate care for all patients.
Regards,
Howard Rutman, MD, FACC
Medical Director
Taro Pharmaceuticals, U.S.A., Inc.
