Have you ever wondered if companies that are under an FDA consent decree got warning letters from the FDA first? The answer is YES. FDA uses warning letters as one of the many methods to bring firms into compliance with regulations. FDA's pattern in the past shows that multiple warning letters are issued before a consent decree is sought. Thus the warning letter is just that-it means that the firm is at risk for further regulatory action by FDA. What does FDA issue warning letters for? As 2006 comes to a close, FDA has issued about 230 warning letters between CBER, CDER, and CDRH. Most of the warning letters were issued due to deficiencies in a firm's cGMP or Quality Systems Regulation. A quick analysis of the total number of warning letters issued for the three centers that regulate human drugs, biologics, and devices (excluding foods and vet products) shows that about 100 warning letters were issued by mid Dec 2006 for cGMP and QSR non-compliance. The second major category was labeling/misbranding/false and/or misleading claims, at about 68 warning letters through mid Dec 2006. These warning letters are often written by FDA in an attempt to reel in overzealous promotion or marketing materials that may promote a drug/biologic/device with a claim that go beyond what FDA approved, or what is supported by a clinical trials. The balance of the warning letters written by FDA is smaller in number, from only one (1) for HCTCPs to 22 for clinical investigators.
Odds are that your firm will never receive a warning letter from FDA. If it does happen, BCG consultants can help reduce your firm's risk profile for further warning letters and/or injunction, by helping to correct compliance deficiencies and drafting constructive responses to FDA. For additional information, please contact John R. Godshalk, MSE, MBA Page Updated August 21, 2008 |
