FDA: Researchers To Disclose Ties To Rx Companies
The Food and Drug Administration is proposing a new rule that would require drug and medical device companies seeking FDA approval "to disclose if anyone involved in clinical research on the products had a financial interest in them," Bloomberg News/Washington Times reports. "This regulation will help assure that the process is thoroughly open and aboveboard," said FDA Lead Deputy Commissioner Michael Friedman (Copp, 2/3). The new rules, which would require doctors to disclose whether they received "stock, consulting fees or other financial support" from drugmakers, will "take effect in a year," the New York Times reports. In addition, "the FDA must be informed when researchers have any proprietary interest, like a patent, in the products they are studying." The FDA must also be informed if "clinical investigators have more than $50,000 equity in a drug company during the time of their studies, or for one year afterward, or whether the company has given the researcher more than $25,000 in consulting fees, grants or equipment during the time of the study or for one year afterward."
In The Know
The FDA will keep the financial information of physicians private, the New York Times reports, unless "the agency determines that a potential conflict might have influenced the outcome of a study." FDA External Affairs Deputy Commissioner Sharon Smith Holston said, "We want to err on the side of protecting the individual, unless we feel that the public interest outweighs the privacy interest."
Biotechnology Industry Organization official Alan Goldhammer said, "Our members are fully supportive. Our reading is that it appears to be very reasonable." The Pharmaceutical Manufacturers Association of America had no comment on the rules. Consumer advocates say the new rules are "long overdue." Executive Director of the Center for Science in the Public Interest Michael Jacobsen said, "That they had no policy on this is shocking. It's critical that the FDA know this information and it's also important that the public know" (Stolberg, 2/3).