Dear Doctor Column, March 24, 2008

Generic Drugs: Safe, Effective, and FDA-approved  

Question:

Are generic drugs as good as brand-name products?

Answer:

Generic drugs are equivalent to brand-name drugs in dosage, safety, and strength and in their quality, performance, intended use, and method of administration. All generic drugs must be approved by the Food and Drug Administration (FDA), which requires that generic products undergo thorough testing to ensure they meet the same standards of quality and effectiveness as their brand-name counterparts.  

The FDA bases evaluations of substitutability, or therapeutic equivalence, of generic drugs on scientific evaluations. By law, a generic drug must contain the identical amounts of the same active ingredient or ingredients as the brand-name product. Drug products evaluated as therapeutically equivalent can be expected to have equal effect and no difference when substituted for the brand-name product.  

Before approving a generic drug the FDA compels pharmaceutical manufacturers to perform rigorous tests and procedures to guarantee the generic drug is an equivalent and safe substitution for the brand-name drug. These bioequivalence requirements ensure that the generic drug performs the same way in the body as the original, brand-name product.  

On the FDA Web page that explains the standards generic drugs must meet, the director of the FDA’s Office of Generic Drugs notes, “Most people believe that if something costs more, it has to be better quality. In the case of generic drugs, this is not true. The standards for quality are the same for brand name and generic products.” 

Generic drugs are cheaper because 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, and marketing and promotion of the drug.  

There’s no truth in myths that generic drugs are produced in poorer-quality facilities, are less potent, or are of inferior quality compared with brand-name drugs. The FDA applies the same standards for all drug manufacturing facilities, and many companies make both brand-name and generic drugs. The FDA estimates that 50% of generic drug production is done by brand-name drug companies.  

In order to sell a generic drug, manufacturers must meet eight major FDA standards: 

ØThere must be an FDA-approved brand-name drug that is the reference for the proposed generic. The generic must have the same active ingredient or ingredients and the same labeled strength as the reference product. The generic also must have the same dosage form (tablets, patches, and liquids are examples of dosage forms) and the generic must be administered by the method as the brand-name product.

ØThe manufacturer must show the generic drug is bioequivalent (performs the same) to the brand-name drug.

ØThe generic drug’s labeling must be essentially the same as that of the approved drug.

ØThe manufacturing firm must fully document the generic drug’s chemistry, manufacturing process, and quality control measures. Each step of the process must be detailed for FDA review.

ØThe firm must assure the FDA that the raw materials and the finished product meet US Pharmacopoeia (USP) specifications, if these have been set. The USP is the nonprofit scientific body chartered by the US Congress to set standards for drug purity in the United States.

ØBefore a generic drug can be sold, the firm must show that it maintains its stability as labeled. Once on the market, the firm must continue to monitor the drug’s stability. The firm must show that the container and its closure system won’t interact with the drug. Firms making sterile drugs must submit sterility assurance data showing microbiologic integrity of these products.

ØThe firm must provide a full description of the facilities it uses to manufacture, process, test, package, label, and control the drug. It must certify that it complies with federal regulations about current good manufacturing practices and undergo FDA inspection of the manufacturing facility to assure compliance.

ØBefore FDA approves a generic drug, it usually conducts an inspection at the proposed manufacturing site to make sure the firm is capable of meeting its application commitments and to ensure the firm can manufacture the product consistently.  

To read more about generic drugs visit the FDA’s consumer education page on generics.