The FDA plans to pull one more veil off any potential conflicts of interest among the experts recruited for the regulatory group's influential review panels. The agency posted a proposal to require panel members to disclose the names of any companies or institutions that could create a conflict for them. For the past two years, panel members have only had to state whether they worked for a sponsor or competitor of a drug or device being reviewed.
The agency also plans to provide an idea of the financial interest involved in a potential conflict, offering ranges like $0 to $5,000. Regulators will be able to grant conflict waivers for up to 13 percent of the members meeting on a panel--up from the 5 percent cap it works with now.
"By making fully informed decisions when considering waivers of conflict of interest, and by improving the transparency of those waivers that are granted, FDA can both obtain needed input and maintain external credibility," says FDA Commissioner Margaret Hamburg in a letter posted on the agency's website.
FDA panel members bear a big responsibility in the review of drugs and devices. While their votes aren't binding, regulators typically abide by their opinions.
- here's the story from Bloomberg