For years now, there's been talk of a centralized repository for all drug-testing data, one that's easily searchable and open to all comers--a sort of public library for the pharma-study set. If the databased were to become a reality, pre-approval studies, post-marketing studies and every clinical trial conducted anywhere in the world would be easily accessible and easily analyzed. Safety problems, or the lack thereof, would be easier to spot, or so the theory goes.
Now, as a September 30 deadline looms for legislative package of FDA funding and drug safety measures, House and Senate negotiators are duking it out over this very database. The House wants to specify exactly how the database would be configured; the Senate's version just calls for its establishment. Whether they'll agree in time to push the database into existence is anyone's guess.
- read the Los Angeles Times article
Related Articles:
PDUFA debate highlights drug safety issues. Report
Senate toughens drug safety supervision in PDUFA bill. Report
Waiting game continues for biogenerics. Report