Internal Emails Show FDA, Industry Jointly Framed 'Cures' Device Language

December 10, 2015

FDA and the largest medical device lobbying group worked together to develop proposed legislative language for most of the medical device provisions included in the House-passed 21st Century Cures bill, one of the largest FDA reform bills to pass the House in recent years, and are developing a synchronized regulatory strategy for the Senate version, according to internal emails and documents obtained by Inside Health Policy through the Freedom of Information Act.

President Barack Obama’s nominee for FDA commissioner, who has come under fire for his past relationships with industry, was aware of the partnership between the agency and the device lobbying group on legislative proposals, according to the emails and documents, and attended meetings with the group along with FDA's acting commissioner and the device center director.

The agency defended the meetings with the device lobbying group as standard procedure and said that Congress requested technical assistance from FDA on the Cures legislation. And, while congressional sources claimed the practice of soliciting outside opinion on legislation was critical to the legislative process, sources off Capitol Hill said they were alarmed at the level of coordination between the agency and the device lobbying group and the amount of influence both parties had over the Cures legislation.

On Aug. 7, FDA officials, including Acting Commissioner Stephen Ostroff, Deputy Commissioner and Commissioner-nominee Robert Califf and Center for Devices and Radiological Health chief Jeff Shuren met with representatives from the Advanced Medical Technology Association (AdvaMed), including Steve Ubl, who then headed the association and is now president of the pharmaceutical drug lobby group, and Janet Trunzo, AdvaMed senior executive vice president of technology and regulatory affairs, as well as individuals from Johnson & Johnson, CVRx Inc. and St. Jude Medical, Inc.

A background document shared in advance of the meeting with a number of FDA officials, including Califf and Shuren, as well as Larry Morris, executive assistant to Ostroff, Sally Howard, senior advisor and acting chief of staff to Ostroff and Franklin Joseph, associate chief counsel for the agency, notes that FDA and AdvaMed met regularly during the legislative process and that the agency and the device lobbying arm had jointly written legislative text for Energy & Commerce Chairman Fred Upton’s (MI) signature piece of legislation.

“CDRH representatives and AdvaMed worked together on proposed language for most of the device provisions in 21st Century Cures,” the document states.

Specific provisions listed include: priority review for breakthrough devices, third-party quality system assessment, valid scientific evidence, humanitarian device exemption application, health software and the Clinical Laboratory Improvement Amendments (CLIA) waiver study design guidance for in vitro diagnostics.

AdvaMed, at the Aug. 7 meeting, “thanked Dr. Shuren and the Center for Devices and Rediological Health team for meeting with AdvaMed regularly during the legislative process for getting the 21st Century Cures Act passed,” according to a recap.

AdvaMed and FDA were also working together “to refine their regulatory strategy in a way that is agreeable to both parties” for the Senate health committee's counterpart legislation, the Innovation for Healthier Americans Act, according to the briefing document.

A spokesperson for FDA said agency officials “routinely meet with a diverse group of stakeholders” that include industry, as well as patient groups and consumer groups.

“With respect to 21st Century Cures, FDA met with industry, patient groups, consumer groups and other interested stakeholders to better understand their interests and concerns. Congress regularly asks us for technical assistance about how to modify language proposed by outside groups, as was the case here,” the spokesperson told IHP.

JC Scott, senior executive vice president for government affairs at AdvaMed, said Congress seeking input from stakeholders, including regulatory agencies and trade associations, is not unusual during the legislative process. “The fact that an association and an agency might discuss how a particular piece of legislation might be operationalized or might impact them is not uncommon,” he said in a statement provided to IHP.

An Energy & Commerce spokesperson said the committee and its members welcomed input from all parties, including stakeholders, outside experts and government agencies, and encouraged parties “in and out of government” to find consensus around specific policy proposals.

“The committee and its Members received numerous ideas that were then fleshed out, negotiated, and translated into legislative language with the help of legislative counsel. Many of these policies were then introduced by members and incorporated into H.R. 6,” the spokesperson said.

A spokesperson for the Senate health committee declined to comment. At Califf's nomination hearing on Nov. 17, Chairman Lamar Alexander (TN) said the vetting process for the nominee found no conflicts of interest. “You were nominated on September 17. My staff has spent two months carefully reviewing everything you submitted and has not found anything that would call into doubt your ability to lead the FDA fairly and impartially,” he said.

A GOP aide said it would be “legislative malpractice” for FDA, regulated industry, patient advocates, and the public to not weigh in with policy proposals to suggest to Congress ways to legislate.

In a statement in April following the release of a revised Cures draft, AdvaMed’s Ubl praised E&C for including a number of medical device provisions, specifically noting the expedited pathway for devices, a provision that FDA and the association worked together on proposed legislative language for.

 “The draft includes key improvements to FDA’s premarket program for medical devices -- most significantly the establishment of an expedited pathway for breakthrough, innovative technologies -- which will increase the efficiency, predictability and transparency of the agency’s review process and improve patient access to the best in medical progress,” he said.

Shuren had multiple meetings with AdvaMed over the course of 2015, according to FDA’s public calendar:

  • A Jan. 14 meeting with AdvaMed members to discuss “regulatory reforms.” Other FDA officials at the meeting included William Maisel, deputy director for science and chief scientist at CDRH, and Alberto Gutierrez, director of the Office of In Vitro Diagnostics in CDRH.
  • A June 2 meeting with AdvaMed’s Trunzo on “regulatory efficiencies.”
  • A July 29 meeting with Trunzo to “discuss the details of the 510(k) Modifications Guidance.”

Sources told IHP Shuren also attended and spoke at past AdvaMed board meetings. A spokesperson for the association previously said AdvaMed does not discuss internal meetings and an FDA spokesperson previously said the agency would not release details of Shuren’s calendar or meetings.

Many of the provisions included in the Cures bill were also introduced in both the House and the Senate as standalone measures. Rep. Joe Pitts (PA), chair of E&C's health subcommittee, and Sen. Richard Burr (R-NC), for example, both introduced legislation on priority review for breakthrough devices, a provision for which AdvaMed and FDA submitted proposed language. Rep. John Shimkus (R-IL) introduced two standalone bills, one on third-party quality assessment and one on the humanitarian device exemption application, also provisions for which the agency and the device lobby jointly wrote proposed language. Both provisions were introduced in the Senate as standalone bills earlier this year by Sens. Joe Donnelly (D-IN) and Cory Gardner (R-CO), respectively. Spokespersons for Pitts, Burr, Shimkus, Donnelly and Gardner did not respond by press time to requests for comments.

These documents come as Califf awaits a confirmation vote from the Senate. Some, including consumer watchdog group Public Citizen, have pressed the chamber to reject his application because of his ties to industry.

“During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few,” Public Citizen said in a release. “Califf’s appointment as FDA commissioner would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry, rather than those of public health and patients.”

Gary Pruden, the worldwide chairman of Johnson & Johnson's Medical Devices group, was listed as an attendee at the Aug. 7 meeting with Califf and other FDA officials.

At his confirmation hearing on Nov. 17, Califf defended his relationship with industry. “[T]he United States, and indeed the entire world, depends on a strong, unbiased FDA that can work with industry to advance critical technologies while still making independent determinations to ensure that scientific potential is translated into safe and effective products.,” he said.

Though he stressed the need to find common ground with industry, Califf said it must be done in a way that would not compromise the FDA’s fundamental role. In response to a question from Sen. Elizabeth Warren (D-MA) on whether he agrees with claims made by industry that FDA is too tough, Califf said he had never been a proponent of lowering standards.

Consumer and public health advocates said the relationship between AdvaMed and FDA raises questions about the conflicts of interest at the highest levels at CDRH. “I worked in the House and Senate for a decade, and this would never have been considered acceptable. For years, there was a revolving door between CDRH leadership and the device industry, but this is even worse than a revolving door: It is a partnership that excludes public health and consumer advocates who do not have close ties to industry,” Diana Zuckerman, president of the National Center for Health Research, told IHP. “As a senator, President Obama would have spoken out forcefully against this, but this is his administration, so what is he going to do about it?”

Michael Carome, director of Public Citizen’s health research group, called the revelations outrageous and disturbing. “It demonstrates that the most senior FDA officials colluded with the lead trade group representing the regulated medical device industry to write legislation that was highly favorable to industry’s interests and would weaken the regulatory oversight and approval standards for medical devices,” he told IHP. “Dr. Califf’s participation in this collusion with industry reinforces our view that the attitudes he has developed over his decades-long history of extensive financial ties to pharmaceutical and medical device companies makes him unfit to be FDA Commissioner because he is all too willing to promote the interests of regulated industries over those of public health and patient safety.”

The Cures bill has received harsh criticism from public health experts and consumer advocates, among other stakeholder groups, who say it would lower the safety and efficacy bar at FDA and allow unsafe drugs and devices to enter the marketplace.

“Rather than addressing the true scientific bottleneck in drug and device development, the bill includes unnecessary, costly, and potentially harmful regulatory changes and financial incentives for pharmaceutical and medical device companies that would put patient safety at risk and undermine public health,” groups including the National Physicians Alliance, Public Citizen and Consumers Union wrote in a letter to Congress.

A draft companion bill from the Senate health committee has yet to be released. -- Joe Williams (