Drugmakers Slow to Confirm Cancer Drugs Work May Face FDA Fines


March 30, 2011

Bloomberg

Bloomberg.com reported on drugmakers that win early U.S. approval of promising cancer treatments may face fines up to $10 million if they take too long to confirm effectiveness in follow-up studies. The FDA may also start requiring that such trials be underway before a drug can win expedited approval, according to a report published online in the Journal of the National Cancer Institute. The amount of time saved through the accelerated-approval process isn’t clear from the FDA officials’ report, stated Susan Ellenberg, PhD, professor of Biostatistics, in an accompanying editorial. The regular drug-approval process could take less time than the separate sets of initial studies and follow-ups required for an accelerated approval, she said... Read More