Approval And Regulation Of Generic Drugs
The process of approving a generic drug was simplified
by the introduction of the Drug Price and Patent Term
Restoration Act of 1984 more commonly known as the
Hatch-Watchman Act after its main sponsors.
Generic Drugs are approved, as with all drugs in
America by the FDA or Food and Drug Administration.
Innovator Drugs undergo lengthy clinical testing to
ensure they are safe and do the job they claim.
Generic Drugs are tested differently, as the clinical
trial information already exists for the original
drug; all the generic version has to prove is that it
contains safe ingredients and is bioequivalent (works
in the same way) as the original drug.
Bioequivalence is stated by the FDA to be: “the
absence of a significant difference in the rate and
extent to which the active ingredient or active moiety
in pharmaceutical equivalents or pharmaceutical
alternatives becomes available at the site of drug
action when administered at the same molar dose under
similar conditions in an appropriately designed
study.” (FDA, 2003)”.
This means it releases the same amount of the same
active ingredient over the same time scale as he
Once an existing patent has run out the applicant
submits an ANDA or Abbreviated New Drug Application
and bioequivalence tests are carried out. Once
approved the new Drug is added to the Approved Drug
Products List along with its bio equivalence