Last week we covered news of allegations that J&J’s DePuy Division had continued to sell its metal-on-metal products outside USA despite and after FDA had concluded there were safety problems.
In a letter published on the company’s jnjbtw “people and perspectives” site, DePuy President Anders Ekdahl strongly refutes the claims and reinforces the corporate position, which is to make “unprecedented efforts and measures” to address the needs of patients and surgeons in resolving this situation. From what we’ve seen that’s fair comment. There is no doubt the company has carried the burden of this industry wide problem on its own shoulders in a rather statesmanlike way and at huge expense.
At medlatest we discussed last week the situation in which a company with a product already on the market outside USA can receive a letter concerning progress of its products towards FDA PMA approval inside the USA and how the two are far from inextricably linked. A product cannot be justifiably removed from international shelves just because FDA decide it needs additional data to satisfy their own (different) requirements. We think DePuy agree. Indeed the company confirm in this letter that they did withdraw the product as soon as data from UK’s joint registry indicated there may be a problem.
Source: jnjbtw.com
