Senator Seeks Answer from FDA on Device Makers’ Payments to Doctors

Medtronic Inc.’s payments to the physicians who work on clinical trials for the <"">device maker’s products are attracting scrutiny. In a letter sent Friday to the head of the US Food & Drug Administration (FDA), Sen. Charles Grassley cited Medtronic’s payments when he asked whether the agency monitors such arrangements.

In his letter to FDA Commissioner Margaret Hamburg, Grassley says that a recent investigation discovered that of 50 clinical investigators studying Medtronic products, “almost all … received significant payments.” One of the doctors made $12.5 million in royalty payments from the device maker, while others were described in Medtronic disclosure forms to the government as having a “proprietary interest in the product tested,” Grassley wrote.

The letter did not provide further details on the arrangements, or provide the doctors names.

The Senator’s letter asks if there are financial arrangements “the FDA would consider too significant a conflict to be appropriate for a clinical investigator to be involved in the study?”

According to a Wall Street Journal report, Medtronic earlier this year began disclosing its payments to doctors, and has said that physicians who receive royalties from a product are not permitted to work on clinical trials required for its FDA approval. However, they can conduct research on other products “if they don’t receive royalties on those products.”

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.