Generic Drug FDA Approval Process
For nearly
two decades, America’s generic pharmaceutical industry
has been developing, manufacturing and marketing bioequivalent
generic versions of brand prescription drugs. These generic
products have been used by millions of American consumers, and
offer the same safety and effectiveness as their brand counterparts.
In order
to be deemed therapeutically equivalent to brand products, generic
drugs must have the same active ingredients, same dosage form,
same standards for purity and quality, same standards for manufacturing,
and same amount of drug absorbed over the same time as the equivalent
brand product. Generics are also required to meet the same stringent
government standards for strength, purity and potency as the
brand version.
The
Food and Drug Administration (FDA) has repeatedly affirmed that
the generic approval process is as rigorous and thorough as
the process by which brand drugs are approved. When a generic
drug receives FDA approval, research and clinical experience
indicates that the generic drug is not only bioequivalent but
also clinically equal to and as safe and effective as the brand
name drug it is a copy of.
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 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.
The FDA does not require the generic company to conduct separate
and complete clinical studies for safety and efficacy because
the brand drug has been used safely for many years.
In order
to receive FDA approval, a generic must have the same active
ingredients, same dosage form, same standards for purity and
quality, same standards for manufacturing, same amount of drug
absorbed over the same time, and same clinical effect as the
brand product.
The FDA
also requires that a generic company's manufacturing methods
conform to current good manufacturing practices (cGMP), as defined
in the U.S. Code of Federal Regulations. The company must follow
the cGMPs in all phases of the manufacturing process, and continually
monitor compliance and measure quality control.
Once all
FDA requirements are met, a generic drug is given approval and
typically dispensed under the chemical name of the active ingredient,
although generic manufacturers may also choose to market specific
generic drugs under a unique trade-name. Occasionally generics
may be a slightly different size, shape or color than their
brand counterpart, but these cosmetic differences have no impact
on the safety or effectiveness of a generic prescription drug.
Product Guide 
