title: Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA.
abstract: The regulations for assessing the quality of generic drugs and their bioequivalence to innovator products are outdated and need to be substantially modernized. There are multiple reasons why these changes are needed, including: (i) the regulations remain largely unchanged since the passage of the Hatch-Waxman Act in 1984; (ii) medication therapies have become substantially more complex over the three decades since the passage of the Act; (iii) a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process - there is substantial clinical professional judgment involved and in some instances these decisions should be better informed; and (iv) pharmaceutical ingredients for finished products, whether innovator or generic, are from multiple sources of supply, adding variability in their production, and which may not be accounted for in specification tolerances. When these elements are viewed together, they clearly suggest that more transparency of responsible manufacturers in product labels and updated standards for bioequivalence are required.
authors.affiliation: American Enterprise Institute, WA, DC, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Bate
authors.affiliation: American Enterprise Institute, WA, DC, USA. Electronic address: amathur@aei.org.
authors.forename: Aparna
authors.initials: A
authors.lastname: Mathur
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Harry M
authors.initials: HM
authors.lastname: Lever
authors.affiliation: Medassure Global Compliance Corporation.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Thakur
authors.affiliation: PeoplesPharmacy.com.
authors.forename: Joe
authors.initials: J
authors.lastname: Graedon
authors.affiliation: ConsumerLab.com and PharmacyChecker.com.
authors.forename: Tod
authors.initials: T
authors.lastname: Cooperman
authors.affiliation: Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Preston
authors.initials: P
authors.lastname: Mason
authors.affiliation: University of Utah Health Care Drug Information Service, University of Utah, Salt Lake City, UT, USA.
authors.forename: Erin R
authors.initials: ER
authors.lastname: Fox
mesh_terms: D004348:Drug Labeling / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic / Q000493:pharmacokinetics* / Q000592:standards*; D006801:Humans; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic
keywords: bioequivalence; drug quality.; generics