For the safety of all the public, for the safety of our officers, we need to understand intimately all that can be learned
– William Bratton
You may have noticed that transparency has been a topic of interest lately (for summary, see here). So back in May when the FDA unveiled draft proposals on disclosure policies, it was read with great interest within these walls.
I have since followed public comments to the docket in question (FDA-2009-N-0247). From what I’ve seen, these responses fall into two camps. There is the “status quo” camp and the “make all data available now” camp.
The July 20th comments from Public Citizen’s Health Research Group (HRG) struck me as typical of the second camp. Maybe it’s the recent heat, maybe it’s the recent controversy, but many public interest groups feel that more data should be made public, especially safety data, as soon as it is gathered (i.e., pre-approval). I’m not at all opposed to more data, especially safety data, being released, but I feel compelled to comment on some of these comments. Let’s use tidbits from HRG’s:
“The clinical data from one drug will rarely enable another firm to take any short-cuts or realize any savings on clinical trials of a different drug. Therefore, the release of clinical data will not cause the sponsor competitive harm.
In particular, the safety data, which is of the highest public concern, will rarely have any bearing on work on another drug, even if related.”
Having participated in strategy meetings for various products at all stages of development, I respectfully disagree. Companies look for any information on their competitors’ products and will use it to their advantage. Who can blame them? For example, you may not think that public postings on www.clinicaltrials.gov would have much information useable by competitors, but I’ve met people who’s only job responsibility is to search that very site for intelligence on their competitors.
To quote the Drug and Device Law (again).
“If you think the pioneer/generic wars are bad now, imagine how they’ll be when everyone knows exactly what applications are pending for what.”
Don’t get me wrong, I’m not saying that I’m in the “status quo” camp. I like the idea of increased transparency (especially for safety data), but it does not have to come at the cost of inhibiting innovation. Furthermore, if you’ve ever collaborated with the FDA, you know that safety is their primary concern.
So, is there a middle ground? I’m hopeful. The FDA has really been pushing their transparency agenda, which should result in more data getting into the hands of the public for analysis.
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