PhRMA said the reasoning behind a sharp cap on samples mandated by its European counterpart doesn't apply in the US.
GlaxoSmithKline CEO Andrew Witty, who also serves as president of the European Federation of Pharmaceutical Industry and Associates (EFPIA), said in an EFPIA statement dated June 24 that “full adherence” to a new set of codes, one of which limits the number of samples a company can offer to any one physician (in the EU), is “essential,” and that “breaches should not be tolerated.”
Asked whether pharmaceutical companies in the US would be held to similar drug sampling limitations, PhRMA issued a statement emphasizing the “value of pharmaceutical samples” in the US, both for physicians and patients.
The ceiling on samples, known in shorthand as the “4 x 2” rule, limits EFPIA's members—which include all of the top 10 pharmas—to four sample packets per year, per doctor, for no more than two years after a drug is approved, according to the trade group's leadership statement.
Colin Mackay, an EFPIA spokesperson, said in an email that “there will be penalties” for non-compliance among member companies, adding that “even self-regulation needs some kind of sanction to be effective,” although those penalties have not yet been codified, according to Mackay.
“There are many significant differences between European health care systems and the health care laws in place in the United States,” said PhRMA SVP Ken Johnson, in the statement. “In the US, free samples have helped improve the quality of life for millions of patients.”
Samples account for a large share of promotional spending in the US and are vital to both product launches and detailing, helping reps get a foot in the door with increasingly unavailable physicians.
Reps at GSK were not immediately available for comment.