Given the controversy over AquaBounty’s GM salmon, I can only assume this headline is sarcastic:
By Kim Carollo, for ABC News, Surprise: FDA Panel Unable to Reach Conclusion on Genetically Modified Salmon
After two days of hearings, several members of an 11-member advisory panel of the U.S. Food and Drug Administration found that there are not yet sufficient data to determine that a genetic modification that enables salmon to grow twice as quickly is safe for the affected fish or for consumers.
The panel, made up of outside experts, did not vote or make a recommendation on whether to approve these fish for human consumption….
Most of what’s in the story (other than the non-decision itself) is not new, and will be familiar to everyone who has been following this story.
It’s worth mentioning that this story gives just a hint at the complexity of the FDA’s decision-making process, which includes at least the following:
- The Commissioner (currently Dr. Margaret A. Hamburg);
- The panel of outside experts, charged with making a recommendation to the Commissioner;
- Staff scientists (who produced the report submitted to the panel)
- Scientists for AquaBounty, who generated data to submit to the FDA;
And then, of course, there’s the public commentary process — a process which critics have said was inadequate, in this case.
As I’ve noted elsewhere, there’s plenty of criticism out there regarding the effectiveness of the FDA in general (see How Good (or Bad) is the FDA?). One of the key worries has been about political and corporate interference. Understanding the key contributors to a regulatory decision — including the key pieces of the FDA’s own process — is crucial to figuring out a) just how good (or bad) the FDA is at its job, and b) how to make the process better.