The Food and Drug Administration has admitted that politics trumped a scientific review in the case of a medical device approved in late 2008 (H/T ScienceInsider and elsewhere). The device in question is the Menaflex, which is a collagen scaffold device designed to assist in meniscus (cartilages in the knee that helps maintain the joint during movement) repair. The preliminary report is extensive, and covers a 17-year review that led to the device’s approval. However, part of the report concerns “the agency’s failure to respond appropriately to external pressure on decision-makers” (page 2) – something that ought to rile up the “War on Science” crowd, but probably won’t.
From the report:
“Although inquiries from members of Congress about FDA’s handling of a constituent’s product application are not unusual, interviewees described the Congressional involvement in the ReGen matter as highly unusual not only in the members’ persistence but also in members’ interest in specific, substantive aspects of the device’s review. The Director of FDA’s Office of Legislation described the pressure from the Hill as the most extreme he had seen and the agency’s acquiescence to the Company’s demands for access to the Commissioner and other officials in the Commissioner’s office as unprecedented in his experience.” ( Page 8 )
“Several interviewees, including individuals with thirty years of experience with the FDA, describe the ReGen matter as among the worst experiences in their professional careers, in large part because of the chaotic sense created by persistent pressure on agency decision-makers and processes.
“The pressure came not only from Congressional members and the Company’s political consultant, but also from FDA leadership — in particular, the FDA Commissioner. Beginning around this time and continuing until the months before clearance of ReGen’s final 510(k) on December 18, 2008, the Commissioner became involved in decisions typically committed to the Review Division or, if escalated, the Center Director.” (Page 9)
There are a number of different issues connected to this review, of which the outside pressure is just one. Attachments 3A and 3B provide a timeline of the review process and a list of departures from standard rules and procedures. This comes on the heels of a request to the Institute of Medicine to conduct a review of the process that reviews medical devices like the Menaflex, and I certainly understand why the request was made. It also helps explains some of the departures and shakeups at the FDA, and I hope the house cleaning continues. While politics often trumps science, this was a situation where specific scientific procedures and standards were instituted in the agency, and violated. That shouldn’t be tolerated.