Posted by jay on December 1, 2001, at 14:10:29
In reply to Re: I AM NOT insensitive to anyone! » gilbert, posted by Pamela Lynn on November 30, 2001, at 15:02:33
I hope this clears the air on some of the questions. You all have valid points, but please read.
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http://cpmu.org/Generics.html
Generic Versus Brand Name Prescription Drugsby David V. Mihalic
Temple University
School of PharmacyMany people feel generic versions of prescription drugs are inferior for the same reasons that generic versions of their favorite shampoos or cereals are inferior. However, though they are called "generic," these prescription drugs are expected to meet the same standards required of the innovator or brand name product. The Food and Drug Administration is required to review and inspect the generic version of a drug just as they would with an "innovator" or brand name product.
In 1984, legislation was passed that ushered in the beginning of the generic drug era. The Drug Price Competition and Patent Term Restoration Act, or Waxman-Hatch Act, passed in 1984, allowed for lawful production and distribution of generic drugs. Four years after this Act was passed the generic drug industry was rocked by scandal as it was discovered that some ten or more generic companies had fraudulently represented data to the Food and Drug Administration (FDA) to gain approval for their generic version of a drug5. This was largely due to the pressures of dozens of companies competing to get approval for generics that could mean millions of dollars to those companies. The FDA’s procedures for approving these generic drug applications were inadequate to evaluate the overwhelming number of applications being submitted. The pressure applied by the generic drug firms on the FDA was immense and many drugs were not reviewed with the scrutiny they should have been. As a result, the bad press from this scandal created a feeling that generic drugs were inferior and potentially harmful. This feeling has, in many cases, survived to this day. Shortly after this event, the FDA reevaluated its procedures and protocols and examined 2800 samples of generic drugs right off the shelves5. Since 1990, the FDA has been conducting inspections of generic drug facilities to ensure that data collected is valid and that the facilities are within the standards set forth by the FDA for sterility and purity. These inspections include review of records, sample batches of the drug, the production facilities, the environmental control of batch storage areas, and the labeling procedures used to prevent medication mix-ups. The FDA has assured, through these inspections, that the generic drug product the patient receives is of comparable quality to the brand name product.
The major difference between a brand name drug and a generic is the research required for the innovator (brand name) company to discover the new biochemical substances that eventually become new drugs. This research is essential to finding new and better treatments for various diseases, but can be expensive. On average it can cost a drug company about $500 million to bring a new drug to market. While much of this cost is passed on to the consumer, the pharmaceutical industry returns most of the money to research and development of new products and you can see why this is important.
The FDA grants the innovator (brand name) company a patent of exclusivity making it the only company able to produce and sell the drug. The patent expires 20 years from the start of drug development to drug marketing. When it does, generic companies are then allowed to manufacture and sell the drug.
For the healthcare industry, generic drugs offer significant savings to consumers. The cost of generic drugs averages 40 to 60 percent below the cost of the innovator or brand name drug4. For this reason 63.0% of HMOs in 1997 required the dispensing of generic drugs, when available, over brand name drugs in order for them to decrease costs of drug therapy 1. A relatively recent case in point came with the advent of a generic form of the antihypertensive drug, captopril (Capoten). Originally, the cost of this prescription drug was about 73 cents per tablet or $73 dollars per 100 tablets. After generic versions were produced, the price dropped to $5 dollars per 100 tablets2. In an industry that is increasingly cost conscious, the healthcare industry has found its cost-savings savior in generic drugs.
So, is a generic drug just as good as the brand name version? The generic company’s version of the drug has the same active ingredient with the same chemical purity as the brand name drug. Other ingredients such as tablet fillers, binders, coatings, or flavors may be different. The generic company does not have to submit data to the FDA regarding the effectiveness and safety of the medication because the innovator (brand name) company has already established these. This results in a significant cost savings for the generic because it does not need to spend the research dollars the innovator spent to create the drug originally. For this reason, it costs the generic company less to market the drug and this savings can be passed on to the patient.
When an innovator’s patent for a drug expires, generic companies may request to the FDA, through an application called the ANDA (Abbreviated New Drug Application), to manufacture and sell their version of that drug. The ANDA, though smaller in size than the NDA (New Drug Application) that innovators are required to submit, is an extensive document containing many sections addressing the ultimate safety and effectiveness for that drug.
The FDA focuses on two main areas in the ANDA. One area is the Chemistry and Manufacturing section. For orally administered drugs, this section provides data to the FDA that must prove that the company can manufacture the drug product and that each unit of drug is consistent in potency, stability, and sterility. The second section is the bioavailability or bioequivalence section. This section is a collection of data that must prove that their version of the drug can attain the same absorption from the gastrointestinal tract to the bloodstream as the innovator’s product. This issue is so important that generic drugs are rated by it. The rating system is based on a two-letter code (for example AA, AB, and B_ ). A generic that is AA rated has essentially the same absorption to the bloodstream (bioavailability) as the innovator’s product. A generic that is AB rated (most generics are AB rated), has had differences in bioavailability from the innovator that have been resolved to the satisfaction of the FDA. A generic drug that is B (whether it is BB, BO, BP, etc…) rated does not have the same bioavailability as the brand name product and they should not be used interchangeably without the knowledge of your doctor and pharmacist. This does not mean that a generic drug that is B rated is not good or can not be used. It simply means that if you are started on that generic, you should not switch to the brand name or vice versa especially if that drug has a narrow therapeutic range (the concentration of the drug in the body has to be monitored carefully, such as warfarin, digoxin, or anticonvulsants). There are not many B rated generic drugs on the market.
The fact that generic drugs are similarly regulated to brand name drugs should confirm their safety and effectiveness when used properly. As previously stated, generic drugs contain the same active ingredient as the brand name, but fillers, flavorings, or coatings may differ. Because of these differences, a patient may find he/she is allergic to an excipient (inactive ingredient) found in the generic version which is not contained in the brand name version. However, this occurs at the same likelihood as someone having an allergy to an excipient in a brand name drug. In fact, if a person is known to have an allergic reaction to an excipient in the brand name product, it may be advisable to use the generic version if it does not contain that excipient. Cases like this are generally rare as these common fillers and flavorings are found in many non-drug products as well.
Finally one must also consider this. With the potential to lose millions of dollars to a generic company’s product, many brand name companies have now either bought smaller generic companies or created their own. What this means is that the generic drug you are taking could have come out of the same production facility as the brand name product. The only differences are the labeling, tablet or capsule design, and the price. They also continue research and development for new products. It is reported that almost 80% of generic drug products made in the United States are made by brand name firms7. Therefore, with regard to most generics made in the United States, the generic version is identical in all but perhaps appearance.
Key Points to Remember:
Generic drugs are not inferior to brand name versions.
If you have any questions about your prescription drugs, you should ask the pharmacist if the generic version is A rated or B rated compared to the brand name.
Remember that B rated does not mean the generic is bad, it simply means it should not be freely interchanged with the brand name version without the knowledge of your doctor.
You can ask your pharmacist if the drug you may be taking is a drug with a narrow therapeutic index. Drugs in this category should be closely watched if you have switched from a brand name drug to a generic that is B rated.
You should also check with your doctor to see if the drug concentration in your system would need to be checked after such a change. Drugs in this regard may include warfarin (Coumadin), phenytoin (Dilantin), levothyroxine sodium (Synthroid), and digoxin (Lanoxin), among others.
As always, you should tell your physician and pharmacist about all the medications you are taking; including over-the-counter products (e.g. TylenolÒ , MotrinÒ , or other pain relievers, cold/cough preparations), herbal remedies and vitamins.
Bibliography
Waltermire, Richard D. RPh., MS "Direct-to-Consumer Advertising of Rx Drugs Can Be Harmful to Your Health." Drug Benefit Trends. 10(10): Pg 60-61, 1998, SCP Communications, Inc..
Sakson, Steve "Competition Cuts Into Generic Drug Firms’ Bottom Line" The Associated Press Sunday May 11th, 1997. 50 Rockefeller Plaza, New York, N.Y. 10020.
Alper, Philip R., M.D. "Are Generics Taking Over?" HealthLine Magazine December, 1995.
"The Importance of Generic Drugs" PCS HealthSystems, www.pcshs.com/benefits/prescription/generic.html.
"History of the Generic Drug Industry" Barr Laboratories, www.barrlabs.com/drugpast.htm..
"Trend of the Month: More HMO’s Are Using Drug Formularies" Drug Benefit Trends 11(2): Pg.8-9, 1999, SCP Communications, Inc..
Yorke, Jeffrey "FDA Ensures Equivalence of Generic Drugs" FDA Consumer Special Report of New Drug Development in the United States January, 1995. www.kali.ucsf.edu/social/fda_reports/2098.217a.html.
poster:jay
thread:85386
URL: http://www.dr-bob.org/babble/20011123/msgs/85743.html