FDA Ignores Good Laboratory Practice Regulations



According to the Project On Government Oversight (POGO), officials at one of the subdivisions of the Food and Drug Administration, the Center for Devices and Radiological Health (CDRH), have not been monitoring manufacturers of medical devices. POGO is an independent nonprofit whose goal is to investigate and expose misconduct and corruption at the federal level. The CDRH is responsible for the oversight of the safety of medical devices. The regulation they seem to be ignoring is called the Good Laboratory Practice (GLP) regulation.

The GLP regulation was issued in 1979 as a way to protect patients from unsafe drugs and devices by setting safety standards of lab testing for the manufacturers of these things. As it stands now, the manufacturers and the testing facilities are responsible for monitoring their own compliance.

POGO has called this decision “shocking” and “stunning in its contempt for the protection of patients.” The decision seems to have been made by top CDRH officials over the objections of rank-and-file scientists working on at these facilities. What’s just as disturbing if these allegations are true is that the decision was made behind closed doors.

The CDRH is responsible for making sure life saving medical devices, such as pacemakers, replacement valves, coronary artery stents, and defibrillators are not going to harm a public that depends on them. With several high profile blunders in the recent past, the FDA can ill afford another one, even if it is simply one that can be easily cleared up with stricter enforcement. As a result, POGO has outlined several points in which the FDA can reverse a problem that has the potential to injure and kill many patients because of defective medical devices.

Summary of Recommendations

  • The GAO or HHS IG should audit records containing evidence of compliance or noncompliance of manufacturers with the GLP regulation.
  • Congress or HHS IG should investigate the decision by senior CDRH officials to deemphasize or ignore enforcement of the GLP regulation.
  • If a marketed device malfunctions, the role of possible GLP noncompliance should be considered and the findings should be made public by the FDA.
  • After facts have been established post-audit, the CDRH should implement a program to enforce GLP.
  • The budget of the FDA should be doubled by Congress by 2012.
  • Full transparency of all agencies should be required by the FDA, except those prohibited by law.
  • Federal employee whistleblower protection should be strengthened by Executive Order issued by the President and legislation should be passed by Congress regarding this.
  • Congressional legislation should be passed to allow injured patients to file lawsuits.