title: Trials and tribulations in the removal of dextropropoxyphene from the Australian Register of Therapeutic Goods.
abstract: • The Therapeutic Goods Administration determined in November 2011 that dextropropoxyphene should be removed from the Australian Register of Therapeutic Goods. This is consistent with this drug's removal from the market in many other developed countries. • However, dextropropoxyphene is still on the market in Australia owing to a series of appeals made to the Administrative Appeals Tribunal (AAT) by the drug's manufacturer. • There is a difference between the standards by which the AAT judges the safety and efficacy of medicines and the standards used for registering therapeutic goods by regulatory agencies worldwide. • This raises the question as to whether the appeal process against TGA decisions appropriately serves the Australian public interest.
authors.affiliation: Medical Professorial Unit, Prince of Wales Hospital Clinical School, Sydney, NSW, Australia. n.buckley@unsw.edu.au
authors.forename: Nick A
authors.initials: NA
authors.lastname: Buckley
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Faunce
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D001315:Australia; D011431:Dextropropoxyphene / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D033161:Government Regulation; D006801:Humans; D009294:Narcotics / Q000009:adverse effects*; D055553:Prescription Drugs / Q000009:adverse effects; D056737:Safety-Based Drug Withdrawals / Q000331:legislation & jurisprudence*; D013375:Substance Withdrawal Syndrome / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D009294:Narcotics; D055553:Prescription Drugs; D011431:Dextropropoxyphene