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Frequently Asked Questions About Generics

 

What are generic drugs?

If generic drugs are the same as brand drugs, why are they sometimes different shapes, sizes and colors?

What kind of savings can generics generate for American consumers?

How are generic companies able to offer a product that is much less expensive than the brand product?

Generic drugs may save consumers money, but are they as safe and effective as their brand counterparts?

Do brand companies have more modern manufacturing facilities than generic companies?

Why isn’t there a generic version available for all brand drugs?

Importation seems to be a perfect answer to lowering prescription drug costs. Why do the brand and generic pharmaceutical industries oppose this initiative?

When should a generic drug not be substituted for the brand name drug?

Who can the consumer turn to for more information about the benefits of generic products?
 
What are generic drugs?
Generic drugs are versions of brand drugs whose patent terms have expired. Generics are referred to by their chemical or generic name. For example, fluoxetine is the generic name for Prozac.
 
If generic drugs are the same as brand drugs, why are they sometimes different shapes, sizes and colors?
All pharmaceutical products, whether brand or generic, vary slightly. Sometimes a brand company patents the appearance of the drug or the brand drug may be protected by trademark or common law. This may prohibit a generic manufacturer from adopting the appearance of the brand drug. However, the same testing that assures batch to batch consistency for a brand product is used to ensure equivalence of generics. Any cosmetic differences between the generic and the brand product in no way impacts the sameness or safety of the generic version.
 
What kind of savings can generics generate for American consumers?
Generic pharmaceuticals can cost 30 - 80 percent less than the equivalent brand product. For every healthcare dollar spent on medicines, American consumers spend less than eight cents on generic drugs versus 92 cents on brand drugs. This is despite the fact that generic drugs are dispensed for nearly half of all prescriptions.
 
In 2004, the average price of a prescription filled with a generic drug was $28.74 and the average price of a prescription dispensed with a brand drug was $96.01. When substituting an equally effective generic drug for the brand product, American consumers saved an average of approximately 70 percent. With healthcare costs rising exponentially, that is a savings every American can use. Generics offer these savings without sacrificing quality, safety or effectiveness.
 
Generics offer these savings without sacrificing quality, safety or effectiveness.
 
How are companies providing generic products able to offer a product that is much less expensive than the brand product?
Generic companies spend little money on marketing generic products. Because there are often multiple generic competitors for each product, and because generics are sold under the same chemical name, what limited advertising and marketing activities occur are used to ensure that trade customers (drug store chains, wholesalers and pharmacies) are aware that a generic is available.

In addition, the expense of developing a generic product is much lower than the typical expense of developing a brand product. This is why brand companies receive market exclusivity; it ensures that they can recoup their investment in new product development.

In order to market a generic equivalent to a brand pharmaceutical company’s drug product (once the market exclusivity on the innovator's product has expired), a generic pharmaceutical company uses the Abbreviated New Drug Application (ANDA) process of the Food and Drug Administration (FDA).

Under this process, the generic manufacturer uses the safety and efficacy data supplied by the brand company, and must only prove to the FDA that its generic product is equivalent to the branded product.

 
Generic drugs may save consumers money, but are they as safe and effective as their brand counterparts?
Absolutely. To be approved, a generic must have the same active ingredients, same dosage form, same standards for purity and quality, same standards for manufacturing and same clinical effect as the brand product. As far as safety, the FDA requires all drug manufacturers and their facilities to adhere to specific guidelines, called current Good Manufacturing Practices (cGMP), no matter what the drug and no matter who the manufacturer.
 
To ensure compliance with these standards, the FDA makes nearly 3,500 inspections a year of both brand and generic companies.Do brand companies have more modern manufacturing facilities than generic companies?
No. Generic companies have facilities comparable to brand firms. The FDA requires both brand and generic companies to conform to the same high manufacturing standards, known as current Good Manufacturing Practices (cGMPs). To ensure compliance with these standards, the FDA makes nearly 3,500 inspections a year of both brand and generic companies.

Why isn’t there a generic version available for all brand drugs?
When brand companies develop a new drug, they are granted patent protection or another form of exclusivity for up to 20 years. The patent protects the drug’s research, development and marketing activities. When the patent expires, drug companies may introduce generic versions but only after they are thoroughly tested by the manufacturer and approved by the FDA.
 
Importation seems to be a perfect answer to lowering prescription drug costs. Why do the brand and generic pharmaceutical industries oppose this initiative?

The generic pharmaceutical industry opposes importation for several reasons. First, data used to support importation considers only a handful of top-selling brand name drugs and exaggerates the potential savings. A more comprehensive representative sample of drugs purchased by U.S. consumers found that average prices in Canada, Germany, Sweden and Switzerland were comparable to or higher than those when U.S. generic drugs are included in the comparison.

The quality of America’s prescription medicines is the highest in the world. Importation would significantly undermine this quality standard. There is no mechanism for assuring whether imported drugs meet basic quality standards or whether they are expired, sub-potent, properly labeled, contaminated or counterfeit. Importation places consumers in the dangerous position of “buyer beware” without any mechanism to protect their safety.

If importation is allowed, consumers will be able to import medicines of questionable quality, with no restrictions on the amount or frequency of the importation. Foreign pharmacies and wholesalers will not be subject to FDA or state oversight, there will be no assurance of appropriate drug handing, and no ability to prevent shipment of counterfeit or tainted drug products directly to consumers.

When should a generic drug not be substituted for the brand name drug?

The simple answer to this question is: Never.
FDA-approved generic drugs that are rated bioequivalent (AB-Rated) to the brand drug must prove that they offer the same safety and effectiveness as the brand name prescription drug. Although some groups would suggest that certain drugs, such as mental health drugs, should not be substituted, there is no scientific or clinical evidence to suggest that the generic will not offer the same benefits as the brand drug, at a substantially lower cost to the patient.

Who can the consumer turn to for more information about the benefits of generic products?

The pharmacist plays a key role in explaining the quality, medicinal comparability and financial benefits offered by generic products. Recent surveys show that when consumers discuss generic pharmaceuticals with their pharmacists, the overwhelming majority conclude that generic products represent an important healthcare alternative, one that is as safe and effective as the branded product. Physicians can also help consumers decide if a generic alternative is available for treating their illness.

The FDA is also an excellent resource for information about generic drugs. Visit the web site at www.fda.gov/cder/ogd/index.htm.

 
 
 
 

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