One of the most frequent questions clients ask me is whether its faster or easier for a device to be approved in Europe than in the US. The US and Europe currently use a different approach and criteria for approving devices, which typically leads to devices being approved faster in the EU. Faster and easier does not always mean safer. As I discussed in a recent interview with Medsider, there are numerous examples of a device recieving EU approval only to be recalled before approaching the FDA for approval.
The New York Times is reporting of another incident where EU approval was followed by a recall and phase out of the device. Barry Meier writes in the Times about an artificial hip implant from Johnson & Johnson that the company marketed in Europe and elsewhere overseas after the US FDA rejected its sale in the United States based on a review of company safety studies. Meier notes that J&J continued to sell a related model in the US during that same period, which earlier went on the market using a regulatory loophole (a modification of a predicate device) that did not require a similar safety review of clinical data.
During some eight years on the market, the two implants were used in about 93,000 patients worldwide, about one-third of them in the United States. Both models were based on the same component, an all-metal hip socket cup that experts say was faulty in design.
The DePuy orthopedic division of Johnson & Johnson, citing declining sales, began phasing out both models of the device — formally known as an Articular Surface Replacement device, which DePuy marketed under the name ASR — in November 2009 and formally recalled them in August 2010 amid reports in databases of orthopedic patients abroad showing they were failing prematurely at high rates.
The Times reports that the FDA expressed doubt about the safety and effectiveness of the device to J&J in 2009. In a confidential letter, the F.D.A. told Johnson & Johnson that company studies and clinical data submitted to gain approval in the United States to sell the model available overseas were inadequate to determine the implant’s safety and effectiveness, according to a summary of the letter reviewed by The New York Times. The Agency also told the company it would need added clinical data to pursue the application, a process that would probably have taken a year or more. DePuy’s receipt of the notice came as regulators and surgeons abroad as well as doctors in this country were raising serious questions about growing failures of both models of the implant.
The Times is careful to note that J&J did not break the law, merely cleverly navigate the regulatory waters. There is no requirement for a company to report FDA refusal to a EU Notified Body. Although easier to gain approval in EU (at least for the current moment) there are hidden costs to pursuing a CE mark before FDA approval. These include the cost of a recall, damage to the brand from a product problem, and potential loss of a device design due to a high failure rate. Striking the balance between arriving first-to-market with the latest technology must be balanced by the best assurance that the device is safe. A CE mark should be a strategic choice, not one of convenience.
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