Regulatory Alert: New FDA Proposed Rule — Sponsor Reporting of Falsified Data

Jack Garvey |

Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners under food/supplement submission rules as sponsors) to report to FDA any instance of falsified data that the sponsor company identifies within a proposed or current human or animal study in support of pharmaceutical, medical device,  food, color additives, or dietary supplement approvals or clearances.    The rule is broad in scope, and is intended to drive down instances of falsified data contained within product approval or clearance submissions to FDA.   The FDA’s intent is to prevent “ambiguity in the current reporting scheme” that has caused confusion among sponsors and to “help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labeling claims and to protect research subjects.”

Initial Analysis: This rule will effectively require the tactical  implementation of certain compliance program elements within the oversight framework for human and animal studies.   At a minimum, it should require additional training on the rule, and expectations regarding the prohibition of falsification of data under any circumstances.  It should also lead to incorporation of personal certifications of data integrity on data submission, and individual acknowledgment of penalties for falsification of data.

2 thoughts on “Regulatory Alert: New FDA Proposed Rule — Sponsor Reporting of Falsified Data

  1. FDA has warned a Chinese API supplier for failing to detect “manipulated” testing data in their QC laboratory. Please see the article from FDA NEWS.

    Chinese API Supplier Cited for Not Detecting Altered Data

    The FDA has warned Xian Libang Pharmaceutical, a maker of active pharmaceutical ingredients (APIs), because its quality control unit failed to detect that an employee had manipulated testing data on incoming raw materials. The failure could affect drugmakers that use the company as a supplier. Xian has been asked to provide a list of all lots of APIs shipped to the U.S. that were released based on nonexistent, inaccurate or unreliable test data, according to a Jan. 28 warning letter posted recently to the FDA’s website.

    From: Drug GMP Report

    1. This is three fold problem.

      1. Hiring Interview failed to identify the employee, who was tempted to manipulate test data.

      2. Training of employees, with an emphasis on an apparent small mistake on their part could have very very serious and far reaching negative outcome.

      3. Lack of solid System to review analysts work carefully AND/or lack of appropriate training of analytical data checker to check all data for all steps up to he first data point

      XIAN LIBANG COULD HAVE CAUGHT THIS MISTAKE, IF THEY HAD APPROPRIATE SYSTEMS AND TRUE TRAINING PROGRAM IN PLACE.

      THAT IS WHY I ALWAYS EMPHASIZE TO UPPER MANAGEMENT THAT ” GMPs ARE NOT REGULATION BUT A “CULTURE” THAT IS A MUST TO BE DEVELOPED THROUGH OUT AN ORGANIZATION, FROM TOP TO BOTTOM.”

      THank You

      Ramesh

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