Since he assumed his post in January, Dr. Jeffrey Shuren, the top Food and Drug Administration official on medical devices, has walked a delicate tightrope.
He has worked hard to reassure a nervous industry that the FDA still values innovation, but has not promised anything specific. But listening to his remarks, an informal understanding seems to emerge: The FDA will most definitely tighten its 510(k) program, but in exchange, the industry will see much more transparency and certainty from the agency.
So what to make of Dr. Bill Maisel? In late July, Dr. Maisel, a prominent expert on medical device safety who has often been critical of the industry, testified before an Institute of Medicine panel charged with recommending ways the FDA and Congress can overhaul the 510(k).
Medical devices have been understandably wary of IOM, especially since there are no industry representatives on the panel. Some even say the results of the report, due next year, are already a foregone conclusion.
“A crazy and paranoid person in the audience would assume IOM already knows where it’s going,” deadpanned Ralph Hall, a University of Minnesota law professor who’s sympathetic to the industry. “But only a crazy and paranoid person.”
Maybe the industry has a good reason to be crazy and paranoid: Unbeknownst to people attending the IOM meeting, Dr. Maisel was already about to accept a new job as the top science officer for the FDA’s medical devices unit.
Last week, Shuren quietly tapped Dr. Maisel as the agency’s first deputy director of science for the Center of Devices and Radiological Health (CDRH). (I say quietly because the FDA has yet to issue a press release and few media outlets have reported the appointment.)
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Dr. Maisel is no figurehead. He will oversee auditing of CDRH procedures to ensure consistency and accuracy across the center. More importantly, however, Dr. Maisel will chair the Center Science Council (CSC), a new body responsible for setting scientific standards for approving devices and issuing recalls.
The CSC is still a little vague. From an FDA report last week:
“As part of its work, the Science Council should meet regularly and be available, as needed, to discuss and vet potential changes in the Center’s regulatory expectations on which staff at lower organizational levels wish to seek additional advice from a wider range of experts, or whose impact could be cross-cutting enough to warrant broad or Center-level attention. Another role for the Science Council relates to increasing the consistency of 510(k) decision-making”
What the report doesn’t say is what role, if any, will CSC play in resolving disputes between medical device companies and staff examiners.
Hall, the law professor, believes the CSC could wield a “powerful role” at the agency.
Dr. Maisel’s appointment will bring no comfort to medical device makers. As director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Massachusetts, Dr. Maisel has been “an outspoken safety expert,” according to FDA Week, a newsletter in Washington, D.C. that closely tracks the agency.
“[I]t is critical that the safety and performance of medical devices be improved, that the frequency of medical device malfunctions and adverse events be reduced, and that patients and physicians be adequately informed about device clinical effectiveness and risks in a timely fashion. In short, FDA needs to improve its science-based device assessments and decision-making,” Maisel said in written testimony to the House Energy and Commerce health subcommittee last year.
Maisel, who is also an associate professor of medicine at Harvard Medical School, is also no fan of how Medtronic Inc. (NYSE: MDT), based in Fridley, Minnesota, handled the massive recall of its Sprint Fidelis leads.
“Manufacturers have repeatedly and knowingly sold potentially defective devices without public disclosure,” Dr. Maisel wrote in an article published 2008 in the New England Journal of Medicine. “For example, after identifying and correcting a design flaw that could cause premature depletion of ICD batteries, Medtronic continued to sell its inventory of potentially defective ICDs without public disclosure. Similarly, the two other major ICD manufacturers, Guidant (now a part of Boston Scientific) and St. Jude Medical, have knowingly marketed potentially defective arrhythmia devices unbeknownst to the public.”
Dr. Maisel concludes: “The welfare of medical device recipients must become a higher priority for the FDA and manufacturers, and it is increasingly apparent that such a change will require congressional action. Essential consumer protections are currently lacking.”
