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 original drug.
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 standards.
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