Are generic drugs inherently inferior to name brand pharmaceuticals?

coachpauly

"Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts." "Actually, generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug. A patent is granted that gives the company that developed the drug an exclusive right to sell the drug as long as the patent is in effect. As the patent nears expiration, manufacturers can apply to the FDA for permission to make and sell generic versions of the drug; and without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply. When multiple companies begin producing and selling a drug, the competition among them can also drive the price down even further." http://www.medicinenet.com/script/main/art.asp?articlekey=46204 Feb 15 12, 9:47 PM

AyatollahK

coachpauly's basic explanation is correct: generic drugs are not inherently inferior to name brand pharmaceuticals. But the rest of the quote isn't entirely accurate. The patent only covers the base chemical compound, but it doesn't cover the manufacturing process or the method of dispersal in the body. Thus, when the patent expires, a generic manufacturer can make a generic that duplicates the chemical compound but may have inferior results when administered. See the discussion with the "People's Pharmacy" columnists here: http://medicationsense.com/articles/jan_dec_08/graedon_int_050808.html Naturally, the FDA thinks that there are no problems with generics: http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm "When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity and potency. Some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass produced, very small variations in purity, size, strength and other parameters are permitted. FDA puts limits on how much variability in composition or performance of a drug is acceptable." "A generic drug must be shown to be bioequivalent to the reference drug; that is, it must be shown to give blood levels that are very similar to those of the reference product. If blood levels are the same, the therapeutic effect will be the same. In that case, there is no need to carry out a clinical effectiveness study and they are not required." Note that not only is a clinical effectiveness study not required, it is not done since the FDA doesn't require it. But that's not a problem, right? Well, in most cases, that is right. As a general rule, most generics really are the equivalent of the branded original. Take aspirin (originally developed by Bayer in Germany) or ibuprofin (originally developed by Boots Group in the UK) as examples. But, as noted in the "People's Pharmacy" article: "The FDA allows different drug formulations and different rates of release and absorption. The FDA accepts generic drugs that are 20% weaker or 25% stronger than the brand name medication. These problems explain why generics are ineffective for some patients, and why generics are too strong and cause drug side effects in others." As you can see, nothing on the FDA site contradicts any of this, despite the FDA's presumption that reaching similar blood levels will produce similar results. Thus, while generics are NOT INHERENTLY inferior, they may be inferior on a case-by-case basis. Feb 16 12, 4:59 PM

george48

Thanks for that detailed explanation! Feb 16 12, 8:32 PM