New Massachusetts Senator Ed Markey Targeted ‘Defective Devices’ As House Member

Article preview from "The Gray Sheet" - July 8, 2013

Democrat Ed Markey was elected to the Senate in a Massachusetts special election June 25. In the House, he was a strong supporter of pediatric device development, but also a vocal critic of industry and FDA’s device safety oversight. In particular, he has pushed for reforms to the 510(k) system that could limit companies’ use of predicate devices in 510(k) submissions.

New Massachusetts Senator Ed Markey Targeted ‘Defective Devices’ As House Member 

Article preview from "The Gray Sheet" - July 8, 2013

Newly-minted Massachusetts Senator Edward Markey is no stranger to device legislative issues after his 37-year career in the House. The Democrat won a June 25 special election to fill Secretary of State John Kerry’s unexpired term, ending in 2014.

Although it is not yet clear the influence Markey will have in the Senate and which committees he will sit on, device firms will likely be eyeing his attention to industry issues.

Overall, Markey’s House record reveals that he is more of a liberal reformer who takes a tough stand backing the health and safety of medical and consumer products compared to his predecessor Kerry, who tended to champion Massachusetts business interests on various health care policy issues.

Markey has long been a supporter of provisions to encourage development and testing of devices in children, but he has also been a vocal critic of industry and of FDA device oversight. In March 2012, his office issued a report entitled “Defective Devices, Destroyed Lives: Loophole Leave Patients Unprotected From Flawed Medical Devices” in support of a provision that would restrict the use of certain predicates to support 510(k)s.

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