Federal scientists associated with the Federal Food and Drug Administration (FDA), have written to the Obama transition team of widespread managerial misconduct within the medical device review department. The letter alleged that “the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers.”
The letter came from the FDA’s Center for Devices and Radiological Health, which is responsible from reviewing medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The letter alleges that the agency managers employed intimidation to thwart scientific debate, the result being that some medical devices were approved despite questions as to their effectiveness. Furthermore, the letter states that scientists were forced to “accept clinical and technical data that [was] not scientifically valid.”
The authors of the letter expressed concern with the lowered standards and the effects that an ineffective review process would have on consumers. Approval by the FDA carries a certain level of integrity and instills a certain level of trust in medical professionals and their patients. However, if that process has been corrupted or compromised then that trust is unwarranted.
Furthermore, from a legal perspective, medical device preemption clauses forbid consumers from bringing a medical device product liability case against manufactures if their products have been approved by the FDA. Essentially the law states that the FDA standards preempt those of individual states. Yet if the FDA approval process is compromised then theoretically they could be approving medical devices that do not actually meet the FDA standards.
In response to the letter, both Democratic and Republican lawmakers are urging Obama to appoint a FDA commissioner who will restructure the agency and restore confidence to both the agency’s scientists and medical experts. And while these accusations definitely warrant review and potentially new policies, there are those in the medical device industry that are concerned that doing so could delay approval of new drugs and devices due to various scientific disputes within the agency.
Kreisman Law Offices has been handling Illinois medical device liability cases for over 30 years, serving Cook County and its surrounding areas, including Arlington Heights, Oak Park, Oak Forest, and Winnetka.