While FDA’s device center has been trying to leverage data provided by an outside “network-of-experts” since late 2011, CDRH Director Jeff Shuren testified to a Senate panel April 28 he is sometimes blocked from using that data due to companies’ confidentiality concerns.

Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander, R-Tenn., convened the hearing in part so that Shuren and his counterpart in FDA’s drug office, Janet Woodcock, could advise the panel on overturning regulatory obstacles preventing the agency from speeding the device and drug approval process. Alexander advised witnesses that the Senate is considering legislative changes parallel to the House’s “21st Century Cures” legislative efforts. (See [A#01150427016].)

“This train is going to get to the station. We are working with the House and the President,” Sen. Alexander said about the Senate’s intent to enact medical regulatory reform legislation.

“If you see anything in current law or regulations that make you unproductive and slows down what you do, tell us now, because this train is going to get to the station, we are working with the House and the President,” he said.

“We tried to set up what we call a ‘network of experts’,” Shuren said, describing one obstacle. “I’d say our biggest hold-up is some questions rely on confidential information in possession of the company … because we can’t share that information, we can’t leverage those experts as well as we could.”

But in Europe, “It’s easier for regulators to take advantage of outside expertise,” Alexander remarked, adding it would be difficult for any agency to keep enough scientists on staff internally who would understand new device innovations. The Senator wants to know if enactment of any new laws is needed for FDA to gain access to the same type of expertise that European regulators enjoy.

CDRH’s ‘network of experts’ was established via a standard operating procedure first drafted in September 2011. (See Also see "CDRH Has New Plan For Tapping Outside Science Experts" - Medtech Insight, 10 October, 2011..) The goal of the network-of-experts program is establish formal agreements with outside groups and experts from who the device office can gain feedback on products, medical indications or other related information.

Difficulties In Recruiting, Retaining CDRH Reviewers Slowing Device Reviews

Shuren also told the committee’s ranking member, Patty Murray, D-Wash., that he is experiencing “a high staff turnover” at CDRH, which in the long run, hurts companies.

“I train [reviewers], they become more marketable, they leave and then they get salaries of two or more times what they are getting paid today” – Jeff Shuren, CDRH

“In the middle of a [product] review, your lead reviewer or medical officer leaves. And I don’t have a deep bench, in my small center.”

The retention problems stem from FDA’s high workload, the agency not being able to pay salaries equivalent to industry, and the requirement for agency job candidates to divest any company stock they hold once they join the government, Shuren said.

“If you come from industry, a lot of times your retirement is in stock, just from that company. I can’t wall them off. They have to divest that stock, and as a result, I’ve had great people say, ‘I’d come, but I can’t because this is my family’s future’.”

He was also frustrated by CDRH’s status as “the training ground for industry.”

“I train them, they become more marketable, they leave and then they get salaries of two or more times what they are getting paid today,” Shuren commented.

“So the industry steals your employees, but they need you?” Murray asked.

“That’s exactly right,” Shuren said.

The House Cures legislation, which was released in the form of an updated discussion draft April 29, includes provisions to streamline FDA’s hiring and retention processes and to enhance staff expertise.

Device Center Trying To Finalize Lingering Draft Guidances

Sen. Johnny Isakson, R-Ga., asked Shuren when he plans to take final action on his portion of the 144 pending draft guidances at FDA. Isakson, Alexander, and Sens. Richard Burr, R-N.C., and Orrin Hatch, R-Utah sent a letter to then-Commissioner Margaret Hamburg in May 2014 requesting the agency bring its many lingering draft guidances to a conclusion. (See Also see "Is Draft Guidance More Than Meets The Eye? Senators Seek Answers From FDA" - Medtech Insight, 8 May, 2014..)

The CDRH Director said that within his program, that 30 were withdrawn as of the week of April 19, and of the 43 remaining, 40 will be finalized within the next 18 months. “The majority of those are actually less than five years old,” Shuren stated.

“The other thing I’d like to point out – we put into our performance goals in December of last year, [commitments] about finalizing draft guidances. And made commitments we will finalize about 80 percent of them within three years, or issue a withdrawal,” he told Isakson. (See Also see "CDRH Sets Performance Goals To Reduce Draft Guidance Ambiguity" - Medtech Insight, 8 January, 2015..)

CDRH Can’t Rely On ‘Network of Experts’ Due To Confidentiality Concerns

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