FDA activities

Investigator attitude and lack of cooperation as well as tip-offs from disgruntled employees are often early warning signs of fraud. The FDA rarely checks with patients and usually only when they have evidence of fraud. It becomes suspicious of the data when there are complaints from subjects, sponsors, or employees of the clinical investigator site; or there are too many subjects and efficacy and toxicity results that are "too good to be true".

If the FDA finds, on looking at fraudulent data in an application, that the data in the application are unreliable, the agency will exercise its authority, under applicable statutes and regulations, to refuse to approve the application e e o o

(in the case of a pending application) or to proceed to withdraw approval (in the case of an approved application), regardless of whether the applicant attempts to replace the unreliable data with a new submission in the form of an amendment or supplement.Thus, if the applicant wishes to replace the false data with a new submission, the new submission should be in the form of a new application. The truthfulness and accuracy of the new application should be certified by the president, chief executive officer, or other official most responsible for the applicant's operations.

The FDA also may seek recall of marketed products and may request new testing of critical products. For drugs, for example, retesting may be requested for products that are difficult to manufacture or that have narrow therapeutic ranges. The FDA may pursue other actions, including seizure, injunction, civil penalties, and criminal prosecution, under the Food Drug and Cosmetic Act or other applicable laws, as necessary and appropriate.

Was this article helpful?

0 0

Post a comment