Generic Drugs Controversy
Generic version of the drug always costs significantly less than the brand name.
According to the U.S. Food and Drug Administration (FDA), all drugs, including brands and generics, must work well and be safe. However, there is some controversy about the safety and effectiveness of some generics. Some physicians continue to prescribe branded medications when generics are available, believing that they are superior. In addition, some patients are uncomfortable with the idea of taking a “substitute”.
What is a brand name drug?
Every business has the right to promote its brand. After a pharmaceutical company develops a drug, it is granted a 20-year patent, which means that no other company can make it for the entire duration of the patent. When the drug is approved by FDA, it is given a generic (official) name and trade (proprietary or brand) name. Brand name medication can only be produced and sold by the company that holds the patent.
Usually, about 10 years elapse between the time a drug is discovered (when the patent is obtained) and the time it is approved for human use, leaving the company only about half of the patent time to exclusively market a new product. If there is no fair compensation from meaningful patent protection, research and development work will slow or stop.
What are generic medications?
When the patent of a brand name drug expires, other companies may produce and sell its generic version. All generic drugs must be reviewed and approved by the FDA before they can be marketed.
FDA requirements for generic drugs:
- Must have the same active ingredients and the same labeled strength as the brand-name counterpart.
- Must have the same dosage form and must be administered in the same way.
- Manufacturers must show that a generic is bioequivalent to the brand-name drug, which means the generic version delivers the same amount of active ingredients into a patient’s bloodstream in the same amount of time.
- The labeling must be essentially the same as the labeling of the brand-name drug.
- Manufacturers must fully document the generic drug’s chemistry, manufacturing steps, and quality control measures.
- Firms must assure the FDA that the raw materials and finished product meet specifications of the U.S. Pharmacopoeia, the organization that sets standards for drug purity in the United States.
- Firms must show that a generic drug will remain potent and unchanged until the expiration date on the label.
- Firms must comply with federal regulations for good manufacturing practices and provide the FDA a full description of facilities they use to manufacture, process, test, package, and label the drug. The FDA inspects manufacturing facilities.
Are generic medications as safe and effective as brand name medications?
In everyday life the term generic is used to describe a less expensive, lower quality copycat version of a brand name product. However, most generics, although usually less expensive, are generally as effective and of the same quality as the brand-name drug. But not always!
According to the FDA, all drugs, including brands and generics, must work well and be safe. The FDA applies the same standards for all manufacturing facilities, and many companies manufacture both brand-name and generic drugs.
In fact, the FDA estimates that 50% of generics production is by brand-name companies.
Despite the fact that the active ingredient in a generic medication is the same as in the brand name counterpart, small differences could affect how they work in your body. For some people, these slight differences may cause the drug to be less effective or lead to adverse effects.
A striking example of such discrepancy is levothyroxine. It is well known that its brand and generic versions may work differently.
Several health organizations, including the Epilepsy Foundation of America and the American Thyroid Association, have raised concerns about the mandatory use of generic medications proposed by some states or required by health plans to save money.
If brand-name and generic drugs are equivalent, why do they act and look different?
The following can explain the existing controversy:
Bioavailability is the rate and extent to which the active ingredient is absorbed from a drug and becomes available at the site of action. Bioequivalence is a comparison of products with respect to their bioavailability. Bioequivalency means that the same amount of active ingredient is delivered to the body by the generic medication as by the brand-name.
The FDA requires that the generic drug have a comparable bioavailability to that of the brand-name drug, but NOT the exact bioavailability. Legally, bioequivalence of different versions of a drug can vary by up to 20%, because for most drugs, such variation does not noticeably alter effectiveness or safety. This means that one generic may have achieved values that lie between 80% and 100% and another values that lie between 100% and 125%.
Although generic drug approval requires demonstration of chemical equivalence and bioequivalence, these equivalencies do not guarantee the equivalence in terms of the clinical effect and the safety. For drugs where the precise control of the dose is critical, plus-or-minus twenty percent may not be appropriate.
Remember, there are “parameters” for bioavailability that must be met, not an exact number.
2. Inactive ingredients
Other common problem is that the inactive ingredients are different. Inactive ingredients such as binders, fillers, coloring and flavoring, are allowed to differ but must occur in a ratio to the active compound similar to that of the reference drug. It is assumed that these inactive ingredients will not alter the performance of the product. However, since these ingredients may contain lactose or gluten, they could change gut motility and absorption in sensitive patients.
3. Manufacturing processes, Technology
Wellbutrin XL (Extended Release) is a well-documented case where many people react to the generic differently. This is not because the drug itself is less effective, but because the generics use a slightly different release technology.
Does every brand have a generic version?
No. Sometimes a drug is too hard to duplicate, or adequate tests are not available to prove that the generic acts the same as the brand. Sometimes the market is so small that producing another version does not make business sense.
Why are generic drugs less expensive than brands?
Generics often cost 30% to 50% less than brand name drugs.
The main reason companies can market their generics at lower prices is that they don’t face the same development costs as brand-name companies. The process of research, development, marketing and promotion can cost hundreds of millions of dollars!
Under the Hatch-Waxman Act of 1984, generic manufacturers don’t have to repeat expensive clinical trials.
In addition, many generics are well-established and frequently used and so do not need to bear the costs of advertising.
Also, there is strong competition in the U.S. When multiple companies begin producing a drug, the competition among them can also drive the price down even further.
These days, faced with competition from generics, pharmaceutical companies often manage to come up with variations on brand-name drugs that are going off-patent. After FDA approval, they market the new versions as state-of-the-art. The most notorious of these cases was the introduction of Nexium, that is a slightly altered version of Prilosec, which was about to go off-patent.
So are generics as good as brands?
This debate has gone on for years. Will there be a definite answer? Unlikely. Why not? Because it would require the generic manufacturers to conduct well controlled double blind studies to prove their medications are as good as the “brand name” one. That is just not going to happen. Why? The cost to do such a study would in all likelihood dramatically increase the cost of a generic and there is always the likelihood to the manufacturer that they discover that their generic does not stack up to a brand name drug.
Electronic Orange Book provides guidance about which drugs are interchangeable.
Updated April , 2011.