Originally published January 1996
Examples of industry-funded harassment of FDA can be found in the publications of the Washington Legal Foundation (WLF; Washington, DC). WLF issues periodic statements attacking the agency on a range of issues and is currently suing it over its efforts to regulate industry-supported scientific and educational materials.
On October 18, WLF issued a counsel's advisory titled "The Pedicle Screw and FDA: Another Example of Politicized Science." (A counsel's advisory is described by the group as being intended "to inform the free enterprise community about a development in the legal policy world that can be favorably influenced by the immediate involvement of legal experts and business and community leaders.") Written by orthopedic surgeon Neil Kahanovitz, the one-page document contrasts FDA's overdue relaxation of labeling restrictions for pedicle screws with the product's standard-of-care status in Europe, Japan, "and the entire modern medical community." In sharp contrast to the 90-day statutory limit for approving a 510(k), FDA let 16 months elapse before calling for public comment on an advisory committee recommendation for reclassification.
Kahanovitz suggested that plaintiffs' attorneys, aided by threat of a lawsuit from the Public Citizen's Health Research Group (Washington, DC) if FDA were to relax its pedicle screw regulation, may have been behind the delay. He urged readers to file comments with the FDA public docket system.
WLF's argument "doesn't hold water when you start checking facts," counters CDRH's Burlington. "You can call it inefficiency, or you can call it priorities, but our orthopedic group was part of the device evaluation program that had the largest workload and initially the biggest staff problem in dealing with 510(k)s." Over the span of 16 months, CDRH gave top priority to completely eliminating its 510(k) backlog, and the reclassification of a new use for existing, available products such as pedicle screws was a lower priority.
There was nothing unusual about how long it took to reclassify pedicle screws, compared to other reclassifications, Burlington says--notwithstanding the extra care taken because of the Health Research Group's request for a moratorium on the use of pedicle screws and its threat of a lawsuit.
The reclassification process was delayed by allegations from "credible individuals" about "problems in the process," Burlington adds. He declines to be more specific because of an ongoing investigation, but says "the action we are proposing [expanded use] is supportable in the face of the allegations."
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.