Healthy Skepticism Library item: 19826

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Magazine

Suanders C
Drug companies fined $100,000 over confusing packs
Australian Doctor 2005 Apr 15
http://www.australiandoctor.com.au

Full text:

An appeal by the manufacturers of the erectile dysfunction drug vardenafil (Levitra) against paying a $100,000 fine for breaching the industry code of conduct has failed.
Medicines Australia, the drug industry’s self-regulatory body, originally imposed the fine on vardenafil’s manufacturers, Bayer Australia and GlaxoSmithKline Australia, for promoting a “performance pack”, which patients could have confused with a “starter pack” containing the drug.
The problem was there were two similar versions of the pack, one of which contained a starter sample of the drug with educational information while the other had information only.
The code of conduct appeals committee ruled that patients could be at risk if they were mistakenly given a starter pack by a doctor and began taking the drug without being assessed for possible contraindictations or told about the possible risks and side effects.
Two separate complaints were made against the companies by the Therapeutic Goods Administration and Pfizer Australia.
The TGA complaint that the drug name Levitra was used on a disease awareness website was also upheld, with the companies ordered to withdraw it in its current form.
The complaints were among 24 code of conduct complaints made to Medicines Australia and finalised in July-December last year. Of these, 18 were found to be in breach of the code.
In another case, Pfizer won an appeal against the imposition of a fine of $50,000 for paying doctors a so-called honorarium of $500 to attend a seminar on celecoxib (Celebrex).