The article on PDUFA in today’s WSJ is headlined “Drug Firms Use Financial Clout To Push Industry Agenda at FDA” conjures up an image of drug companies conspiring to ram useless and dangerous drugs through the FDA. I mean, what else do you with financial clout except water down regulations governing safety and efficacy?
Turns out (and Anna either doesn’t know or doesn’t think it’s important) both biotech and pharma companies would like to devote some user fee money to fund Critical Path programs that would allow the FDA to hire and train scientists who can use new molecular tools and new clinical trial methods leading to more targeted and personalized medicines. Then there is an effort to help the FDA establish collaborations with large health systems to collect clinical data in cooperation with companies after a drug is marketed. Finally, there is talk of devoting some money to promote industry, academic, and agency initiatives like the one created with MIT Center for Biomedical Innovation to develop software for detecting adverse drug effects and reactions of new drugs after they hit the U.S. market or the one with the Critical Path Institute to develop a biomarker to do the same thing before a drug goes into development.
Only a professional scowl like Sid Wolfe (see post above) would complain this is a waste of additional industry funding. Why is it that Mathews couldn’t report on these possibilities?