The House Energy and Commerce Committee, Subcommittee on Health, held a hearing on the regulatory approval process for medical devices Thursday, presumably as preparation for action on H.R. 1346, the Medical Device Safety Act -- sponsored by the committee's chairman, Rep. Frank Pallone (D-NJ). The American Association for Justice certainly regarded the hearing as serving that purpose, specifically citing the legislation in its news release, "Questions about FDA Oversight of Medical Devices Leave Patients Vulnerable."
Yet there are regulatory inefficiencies and ineptitude at the Food and Drug Administration independent of the question whether federal preemption is wise public policy. Witnesses' prepared testimony examined some of these issues, and the GAO submitted a report that described "shortcomings in both premarket and postmarket activities [that] raise serious concerns about FDA's regulation of medical devices." Even though the GAO tends to identify problems committee chairmen want identified, there's still useful detail in the report, "Medical Devices: Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments."
- Chair Pallone's Opening Statement
- Testimony of Marcia Crosse
- Testimony of William H. Maisel
- Testimony of Phillip J. Phillips
- Testimony of Peter Lurie
We do not find any testimony of a White House official urging caution when considering regulatory changes that would encourage costly lawsuits. Health care reform only goes so far.