PROBLEMS WITH GENERICS
Over half of all the prescriptions in the U.S. are filled with generic drugs. Brand name manufacturers make half of the generic drugs. Do you get what you pay for? Buying new cars, clothes, or computer upgrades may hurt your budget, but buying the newest drugs could hurt both your wallet and your health. For prescription medicine, “classic” drugs may be the way to go.
What are generic drugs?
Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, and route of administration, risks, and safety, strength as the original drug, and maybe side effects.
Why are generics cheaper?
Generics manufacturers haven’t paid for developing a drug, so they can sell their product at reduced prices 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. Without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply.
Many generic drugs are now manufactured in China and India where quality control standards are far less stringent than in the U.S. Insurance companies steer patients to generics to keep their costs down, even if customers wanted to switch to a brand name. You have to pay the brand name co-pay, which may be double or triple or significantly higher than the generic ones.
Are generics the same as brand drugs?
Today, virtually all generic drugs are essentially the same as the innovator drugs they copy. They must meet stringent FDA requirements to get approved. Essentially, a generic company must show unequivocally that the generic drug contains the identical active ingredients as the innovator drug in the same amount and must behave in the same way in the body. For all practical purposes, they are the same drug. And it is thus assumed that the generic will have the same therapeutic effect.
But generic drugs are also different. They typically use different inert ingredients, binding chemicals and colorings.
EXCIPIENTS
Excipients include fillers, binders, colors, and coatings, may differ in various versions of a drug. Due to trademark laws, generic and brand-name drugs cannot look identical, so generic pills are often a different color or shape from their counterparts. It’s possible that an individual could be allergic or sensitive to a specific excipient. There aren’t that many excipients, so drug manufacturers choose excipients from the same limited pool. It is the final form of the generic that is tested against the brand, so if an excipient reduced absorption, the generic would fail in the comparative test with the brand.
PROBLEMS WITH GENERICS
False data submitted by several generic drug firms
In their applications to FDA for approval to sell new generic drugs. For example, one generic company admitted to submitting the brand-name maker's drug as its own in an effort to win swift approval of its generic copy.
BRIBING FDA OFFICIALS
Officials of some generic drug firms offered illegal gratuities to FDA employees in the FDA generic drug program. Regrettably, three FDA employees — now former employees — accepted the offers.
POOR REGULATIONS OF GENERIC DRUGS
Some generic drug firms have violated the good manufacturing practice regulations that govern overall production procedures and techniques that help guarantee the safety and effectiveness of drug products. Many are now made in India and China where poor regulations are unenforced.
THERAPUETIC EXCHANGES
The term "therapeutic equivalents" applies only to products that are pharmaceutical equivalents, not to different therapeutic agents used to treat the same condition. The increasingly common and controversial practice of allowing one product with a similar, but not identical, active ingredient to be used in place of another product is more commonly referred to as therapeutic interchange.
BIO-EQUIVALENCE STUDIES
A generic drug must be as therapeutic as its brand name alternative. These studies involving the measurement of plasma drug concentrations are very expensive and time consuming and can fail. To solve this high expense, alternative approaches are used as pharmacodynamic measurements instead of plasma concentrations. Some products result in disagreements between the scientific community and the FDA.
Generic drugs are graded for bioequivalence. To assure scientific rigor in their evaluation and because, they involve a small proportion of drugs, bioequivalence issues do arise. They arise largely because the testing available today is very sophisticated and can detect even small differences in, say, the rate at which a drug is absorbed or the quantity of its breakdown products in the body. Some of the differences these tests pick up may be meaningful and some are not. The FDA decides The FDA can approve generic products that, although plainly not identical to the reference product as required, are viewed by the FDA as close enough.
THE 20% RULE
The law of the land in the US is there can be a plus or minus of 20% of bio-availability of the active ingredient! The FDA still uses the plus-or-minus-twenty percent test to determine blood serum bioavailability (i.e., the amount of active ingredient in the blood over a period of time has to come within plus-or-minus twenty percent of that which is observed when the innovator’s drug is ingested.". Many generic medications don't meet their 20% bioequivalence standard.
WHAT CAN YOU DO?
If you started out on a generic and don't have any problems with it, great! Stay with it. But if the pills changed colors and the meds don't seem to be working correctly any longer, then see if you can get your pharmacist to order your meds from that same manufacturer.
Many elderly take 5-10 medications. Many find they don’t work the way they were told. They increase or stop the generics. This may be why we have more chronic illnesses in our elderly.
What do you think? Visit www.drneedles.com for more information on controversial medical subjects.
SOURCES:
1. Food and Drug Administration, Orange Book web site, preface, introduction and ratings explanation, www.fda.gov/cder/ob/default.htm. Accessed Feb.14, 2002. Lynda Welage et al, “Understanding the Scientific Issues Embedded in the Generic Drug Approval Process, Journal of the American Pharmaceutical Association, Vol. 41. No 6 (November/December 2001), pages 856-867. Don Hare and Thomas Foster, “The Orange Book: The Food and Drug Administration’s Advice on Therapeutic Equivalence,” American Pharmacy Journal, Vol. NS30, No 7 (July 1990), pages 403-405. James Knoben et al, “An Overview of the FDA Publication: Approved Drug Products with Therapeutic Equivalence Evaluations,” American Journal of Hospital Pharmacy, Vol. 47 (December 1990), pages 2696-2700. FDC Reports (The Pink Sheet), “Zenith-Goldline Clozapine Bioequivalence Study Suggested by FDA,” (February 5, 2001), page 29. NIHCM Foundation June 2002
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