PhRMA Opposes Clinical Investigator Finance Rule

While supporting fully the position of the US Food and Drug Administration that unbiased data resulting from clinical research is essential to the drug discovery, development and review process, the Pharmaceutical Research and Manufacturers of America strongly opposes the proposed rule on financial disclosure by clinical trial investigators.

The PhRMA says in a letter to the FDA that the rule is unnecessary, overly intrusive, burdensome and a hindrance to clinical research. It also states that at no time has the FDA indicated that bias of research data related to investigator compensation is a problem. The concern seems to be that it might be a problem.

The proposed regulation on financial disclosure by clinical investigators was published by the FDA last September (Marketletter October 3), and has resulted in considerable opposition, especially relating to the $5,000 threshold for disclosure which is proposed by the agency. The FDA is understood to be particularly concerned about situations which give the investigator a stake in the outcome of a study, such as payments that would be larger in the event of a favorable result, an equity interest in the product, payment in the form of shares or stock options in the company, or payment in the form of royalties.