Senate panel hears testimony on medical device safety frompatients, medical experts.
Daniel Schultz, M.D., director of the U.S. Food and Drug Administration’s (FDA) device evaluation arm—the Center for Devices & Radiological Health (CDRH)—has stepped down.
In an e-mail announcement, FDA Commissioner Margaret Hamburg, M.D., said: “Dr. Daniel Schultz announced his resignation as director of the Center for Devices and Radiological Health. I would like
Daniel Schultz, former director of the Center for Devices & Radiological Health. Photo courtesy of Dan Stevenson for MDMA Annual Meeting.
to take this opportunity to thank him for his long service to the agency and to the public. Dan has worked tirelessly to advance the public’s health through the approval and monitoring of innovative and safe medical devices.”
Hamburg added that under Schultz’s leadership the agency “enhanced” its understanding of the of the “risks and benefits of using medical devices in pediatric populations, increased the agency’s safety efforts by expanding MedSun, and led the agency in the post-market transformation process, which has provided an opportunity to fundamentally rethink the way risk/ benefit information is collected, analyzed and executed.”
In a memo to his staff, Schultz said he and Hamburg came to a “mutual agreement” that his resignation “would be in the best interest of the center and the agency.” Until a permanent head is named, Jeff Shuren, M.D., a physician and attorney, will serve as acting CDRH director. Shuren is board certified in neurology and served as an assistant professor of neurology at the University of Cincinnati in Ohio. In 1998, Shuren joined the FDA as a medical officer in the Office of Policy. In 2001, he left the agency briefly to become the director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services. He returned to the FDA as the assistant commissioner for policy in 2003 and assumed his new position as associate commissioner for policy and planning in 2008. Device groups were quick to praise Schultz’s work.
The Washington, D.C.-based Medical Device Manufacturers Association (MDMA), in a statement, said: “MDMA has appreciated working with Dr. Schultz over the years to provide patients with timely access to safe and effective products and wish him the best.”
Stephen Ubl, president of the Advanced Medical Technology Association (also based in Washington, D.C.), said: “As CDRH director, Dan was instrumental in crafting the historic agreement in 2007 reauthorizing medical device user fees, which has provided FDA’s device program with a stable source of funding to help meet its regulatory responsibilities. In addition, he launched CDRH’s post-market transformation initiative, which is designed to improve the collection, analysis and utility of the agency’s multiple sources of post-market medical device data. Dan also has been a leader in efforts to strengthen and harmonize global medical device regulatory requirements and has supported FDA’s work on the Global Harmonization Task Force.”
Some regard the departure as a positive step for the FDA. In a statement, Ned Feder, a staff scientist for the watchdog group the Project on Government Oversight, also known as POGO, called Schultz’s resignation “welcome news,” adding that the CDRH “has been in desperate need of new leadership.”
“Dr. Schultz’s resignation offers a long-awaited opportunity for openness and reform,” Feder said. “This was a critical first step, but FDA Commissioner Margaret Hamburg still has significant work ahead. Among the needed reforms is dealing quickly and openly to correct the harm caused by retaliation against the extraordinary number of CDRH whistleblowers who have reached out to the Congress, the media and public interest groups including POGO. It also is essential to investigate the allegations made by these insiders, particularly of improper influence over FDA decisions to approve medical devices. Until it is clear that the culture of fear at CDRH is over, it will be impossible to restore integrity to the important work of the CDRH.”
To industry watchers, this move will not come as a surprise. For more than a year, Schultz has been under fire from Congress, the public and even members of his own staff. At the end of last year, a series of letters from internal FDA whistleblowers were sent to then President-elect Obama and key lawmakers alleging improper practices at CDRH.
The letters accused Schultz, Donna Bea Tillman (director of the FDA’s Office of Device Evaluation within CDRH) and other unnamed FDA managers of coercing device review staff into modifying, changing and expediting product evaluations. Since then, there have been calls from a number of sources for resignations within CDRH.
Schultz joined the FDA in April 1994 as a medical officer in the general surgery branch of CDRH. He went on to become chief medical officer in the Division of Reproductive, Abdominal and Radiological Devices. He later served as division director, and then as deputy director and director of the Office of Device Evaluation in CDRH. He has served as director since 2004, replacing David Feigal.
Senate Panel Debates Medical Device Safety
A U.S. Senate panel heard testimony recently from patients and medical experts about the potential dangers of defective medical devices and the impact of a recent court ruling that protects device manufacturers from product liability lawsuits.
The hearing before the Senate’s Committee on Health, Education, Labor and Pensions (HELP) about the proposed Medical Device Safety Act of 2009 examined overturning the 2008 U.S. Supreme Court decision in Riegel v. Medtronic.
In the Riegel decision, the court held that the express preemption provision in the Medical Device Amendments to the Food, Drug and Cosmetic Act bars lawsuits against manufacturers of medical devices that underwent the U.S. Food and Drug Administration’s (FDA) premarket approval (PMA) process—the review process for novel or highly sophisticated devices. Similar legislation also has been introduced in the House of Representatives.
Proponents of the legislation argue that manufacturers should not be shielded from liability and that patients should have the legal right to sue manufacturers if harmed by a medical device. Opponents argue that the Medical Device Safety Act will make devices more costly and, ultimately, less accessible.
“This has had catastrophic consequences for ordinary Americans, said HELP Committee member Sen. Tom Harkin (D-Iowa) during the hearing. “While the FDA approval of medical devices is important, it cannot be the sole protection for consumers. I say that because FDA approval…is simply inadequate to replace the longstanding safety incentives and consumer protections provided by long-standing state tort law.”
Sen. Orrin Hatch (R-Utah) praised the FDA’s efforts saying that FDA officials spend “a tremendous amount of time and resources” evaluating PMA devices and that the agency’s “rigorous” efforts historically have been shown to be “exceptionally efficient.”
Hatch said turning oversight over to individual state courts would hurt the FDA’s expert oversight process—and that the agency has significant and effective authority to monitor and recall devices.
“I do not believe that randomly selected jurors have the necessary scientific and clinical knowledge to perform the same level of analysis as the review by the experts at the FDA,” Hatch said. “Yet, in essence, this legislation would supplant the findings of the FDA with those of juries in state courts. This is not only bad policy from the perspective of device safety, it also would have many unanticipated consequences.”
Some of the consequences Hatch mentioned include a stifling of innovation, higher costs for medical devices and more expensive frivolous lawsuits. He added that it also undermines the current healthcare reform goal by adding costs to the system.
He hastened to add that it is critical to ensure that those who have been victimized by faulty devices are able to obtain adequate compensation, but argued that patients currently aren’t prevented from suing if they have legitimately been harmed by defective devices. If the manufacturer is at fault, due to negligent quality or manufacturing for example, they are protected under the current law, Hatch asserted.
Peter Barton Hutt, a food and drug attorney for the firm of Covington & Burling in Washington, D.C., and former chief counsel for the FDA, articulated a position held by many in the device industry.
“The fact that it [a device] hurts someone doesn’t mean there’s a defect,” Hutt said. “It may save 999 lives, but hurt the thousandth life. That doesn’t mean it’s defective.”
No representatives of medical device industry associations or medical device companies testified, though their influence was felt through the patients testifying before the committee.
Mike Roman, a race car driver from Kirkwood, Mo., testified in support of FDA authority. Roman, who uses a spinal cord stimulator to help manage chronic pain, urged lawmakers not to pass the legislation. He told senators that he understood the device’s risk, but considered the risk “worth it.”
“I testified today because I want to ensure that advanced medical devices like the one that transformed my life will continue to be available for people like me,” Roman said in a statement issued by the Advanced Medical Technology Association (AdvaMed) following the hearing. “My experience shows how vitally important it is for companies to continue developing new treatment options.”
Roman’s right leg was amputated in 1994 due to complications following knee surgery, and he began to experience severe pain. After trying multiple treatments over 10 years, he claimed a new spinal cord stimulator based on cochlear implant technology finally was able to help him manage his pain.
“There are millions of people out there who might one day benefit from breakthrough therapies that are still in development, and we need to consider them when we think about the consequences of this legislation,” he added. “I’d rather not imagine where I would be today if the company that created my device had decided it was not worth the investment to develop the device only to have it devalued by lawsuits.”
On the flip side of the argument, advocating patients’ rights, Michael Mulvihill, a patient from Bettendorf, Iowa, testified that a defective defibrillator lead from Medtronic has made his life a “nightmare.” A malfunctioning lead (which subsequently was replaced) led Mulvihill to be shocked 22 times in 53 minutes—initially while driving his car. Following this experience, he testified that he was unable to drive without feeling anxiety, that the slightest chest pain causes life-crippling nervousness and that his personal life has been adversely affected.
“My hope is that no one else ever has to go through the pain and agony that I experienced with the fractured lead and that Medtronic is held responsible for the injuries it has caused other patients like me,” Mulvihill told the committee.
William Maisel, M.D., director of the Medical Device Safety Institute and a cardiologist with Beth Israel Deaconess Medical Center Harvard Medical School in Boston, Mass., said the FDA’s OK may not be enough.
“FDA marketing clearance or approval of a medical device does not guarantee its safety,” he testified. He added that it isn’t “uncommon for unanswered questions” about a device’s safety and effectiveness to remain at the time of approval.
“Manufacturers often have an inherent financial conflict of interest” in announcing recalls, he claimed. He also added that a “vital consumer safeguard” was eliminated as a result of the Riegel decision.
Following the hearing, Stephen Ubl, president of AdvaMed, issued a strongly worded statement—echoing Hatch’s comments—saying the bill would not “in any way improve patient safety. It will create more frivolous lawsuits and increase healthcare costs, and it will make it harder for small medical device manufacturers to invest in promising new technologies. The bill also will weaken FDA’s regulatory authority.”
He added: “Congress should reject the inaptly named Medical Device Safety Act and reinforce the singularly important role FDA has in regulating the medical device industry. This is in the best interest of patients and our health care system.”
Other hearings are expected to consider the legislation.