04-14-2016
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

An Internet petition to Congress authored by LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer has drawn more than 270 signatures from across the country in its first 24 hours, demanding the removal of CDRH director Jeffrey Shuren from office. Last October, Cofer and some of the current signatories were involved in a 1,500-message email blitz of Shuren’s government in-box calling on him to resign. Shuren and FDA shrugged off that campaign. Now Cofer and her supporters want Shuren fired by Congress. Their petition charges that his leadership has seen the Center “become mission-corrupted, placing industry interests over public health.

“Failures of the CDRH,” it continues, “have harmed countless people and led to many preventable deaths. CDRH is ‘captured’ by industry. Division managers at the CDRH have close working relationships with representatives of medical device manufacturers. Fraud and data tampering occurs regularly in FDA clinical trials of medical devices. The CDRH’s oversight of device trials is weak and ineffective, leading to approval or clearance of unsafe devices.

“Post-market surveillance by CDRH is lax,” the petition goes on. “Problems with medical devices go undetected, which leads to injuries to unsuspecting American citizens. Patient advocacy groups and whistle-blowers who reach out to the CDRH to raise a red flag about problems with a medical device have been shut out or ignored. MedWatch reports of device-related injuries fall into a black hole at the agency.

“We call on the United States Congress to remove CDRH director Jeffrey Shuren from the FDA so that a new leader can take his place. A new CDRH leader must honor the agency’s mission to protect and promote the public health.”

Among numerous comments signatories have posted to the petition are some Cofer characterizes as “brutal” about Shuren. They include this from a Tara Howie in New Jersey:

“In 2011 Shuren, when asked about the 510(k) process, Shuren said he doesn’t know where precisely it is going, but it certainly won’t be scrapped. He believes the system works well, although he knows there are those in the industry with ‘angst’ about the program — and he has seen this concern increasing. But the largest challenges pertain only to a small minority.

“This is my biggest problem with Shuren,” Howie’s comment continues, “the 510(k) process is a legal loophole for untested devices to go straight to market without any pre-market testing, simply based on the fact the device resembles a predicate device. Having had a device implanted that was based on a predicate device that was pulled from the market, yet the devices in me were not shows exactly where a huge problem exists.

“Is Shuren that shortsighted? I think not. In his time at the CDRH he has lied (kinda) under oath, he has pushed his agenda, one that benefits him, yet leaves the consumer, frankly, screwed. The ‘small minority’ Shuren speaks of is not too small actually. Perhaps in his limited view of everything that doesn’t pertain to him, or the lobbyists he’s been making extremely happy, it is small, but if you ask thousands and thousands of consumers what they think of the way Shuren has decided to run the CDRH, they will undoubtably tell you there are many, many problems. Not only ‘minor’ ones.

“How can anyone within the FDA, or specifically the CDRH, be trusted when they work so closely with representatives from medical device manufacturers? The writing is on the wall so to speak. And it’s well past time to make the changes necessary to protect the consumers, and not the wallets of the medical device industry. Greed in this country is putting dollars before clear, rational thinking. And it’s time to change this, along with the leadership at the CDRH, beginning with Shuren, and all of his cronies. Let’s put people back into the conversation, the consumers, the patients…But, don’t ask the thousands of already deceased ones, just ask their families.”

Cofer says her petition is being followed by Pennsylvania Republican congressman Mike Fitzpatrick, and she hopes he will bring it to the attention of his colleagues. Fitzpatrick has strongly supported injured patients’ criticisms of Shuren and CDRH safety management in the power morcellator and Essure birth control controversies.

FDA spokesman Eric Pahon would say only that the agency “is aware of the petition.”