Generic Drugs Overview
Role of the States
Role of the Federal Government
States control rules on pharmacist substitution of generic for brand name prescription State can take the license from you but not federal because they have not given to us on the first place
The federal government through FDA, controls the approval, manufacturing and marketing of drug products across the United States.
Historical: State Antisubstitution law
Antisubstitution Laws Repealed
Prohibited a pharmacist from substituting a generic drug for a brand name prescription unless the pharmacist obtained approval from the prescriber
During the 1970s, the states, one by one, repealed their antisubstitution laws
This opened the door to the increased growth of the generic drug industry.
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
FDA approval of a NDA allows the manufacturer to market the drug in interstate commerce.
For generic drug approval
Intent is not to duplicate NDA as this would be prohibitively expensive.
Early Standards
Generic drug only had to meet USP standards to avoid being adulterated or misbranded Manufacturers could file a "Paper NDA" There were no requirements for bioequivalence until 1984
"Hatch-Waxman"
The Drug Price Competition and Patent Term Restoration Act of 1984 Gave additional patent time to brand name manufacturers Allowed generic manufacturers to work on their copies of the brand name while the patent was still in
force Provided for the Abbreviated New Drug Application (ANDA) as the mechanism for generic drug approval Requires two bioavailability studies Generic must be bioequivalent to reference listed drug
Reference Listed Drug (generally brand name)
A reference listed drug (21 CFR 314.94(a)(3)) means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA.
Other Relevant Terms
Bioavailability The rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action.
Pharmaceutical Equivalent
Drug products are considered pharmaceutical equivalents if they contain the same active ingredient(s), are of the same dosage form, route of administration and are identical in strength or concentration
Pharmaceutical Alternative
Drug products are considered pharmaceutical alternatives if they contain the same therapeutic moiety, but are different salts, esters, or complexes of that moiety, or are different dosage forms or strengths.
Bioequivalent Drug Products
Pharmaceutical equivalent or alternative products that display comparable bioavailability when studied under similar experimental conditions
Therapeutic Equivalent (or generic equivalent)
Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
Products are deemed by FDA to be therapeutically equivalent if they are
approved as safe and effective pharmaceutical equivalents bioequivalent adequately labeled manufactured in compliance with GMP regulations
The Role of the FDA Orange Book
Originally it is "Approved Drug Products with Therapeutic Equivalence Evaluations" States generally use this as the basis for generic substitution
Therapeutic Equ