Welcome to the October installment of "FDA News in Review," where each month we look at the agency's latest decision, approvals, warnings and recalls. Over the last few days one of the hottest topics in pharma has been the issue of preemption, which is being argued before the Supreme Court in the case of Wyeth v. Levine [1]. Those in favor of preemption think the FDA approval shields drugmakers from legal challenges in state court. But what do FDA staffers have to say? According to memos obtained by the Wall Street Journal, the FDA's labeling decisions aren't always based on the best possible information. "[M]uch of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," wrote one top official.
Another important story this month was the FDA's continuing difficulty meeting drug approval deadlines. So far this year the agency missed deadlines for Promacta, Nplate, Telavancin, Entereg, Cimzia, Lexiscan, Kynapid and alogliptin. The FDA says staffing shortages are to blame; critics say the agency is hesistant to approve drugs because of recent safety issues with some high-profile therapies. There were a number of approvals announced this month, however. The agency gave the ok to Genzyme's Myozyme, Lev Pharma's Cinryze and Bayer's Kogenate, among others.
Links:
[1] http://www.fiercepharma.com/tags/wyeth-v-levine
[2] http://www.fiercepharma.com/story/memos-show-fdaers-fought-lawsuit-pre-emption/2008-10-30
[3] http://www.fiercepharma.com/story/industry-voices-creating-center-excellence-china/2008-10-27
[4] http://www.fiercepharma.com/story/fdas-weak-oversight-foreign-pharma-plants/2008-10-22
[5] http://www.fiercebiotech.com/story/regulatory-environment-helps-small-biotech/2008-10-30
[6] http://www.fiercepharma.com/story/adverse-event-reports-hit-record-high/2008-10-23
[7] http://www.fiercepharma.com/story/nyt-devices-get-cursory-fda-scrutiny/2008-10-27
[8] http://www.fiercepharma.com/story/genentechs-raptiva-gets-black-box-warning/2008-10-17
[9] http://www.fiercepharma.com/story/no-more-cold-remedies-kids-under-4/2008-10-08
[10] http://www.fiercepharma.com/story/stent-drug-makers-team-clot-study/2008-10-16
[11] http://www.fiercepharma.com/story/ranbaxy-waves-white-flag-feds/2008-10-10
[12] http://www.fiercepharma.com/story/promised-fda-misses-deadlines/2008-10-20
[13] http://www.fiercepharma.com/story/fda-lets-dying-lawyer-have-tysabri/2008-10-17
[14] http://www.fiercebiotech.com/story/daiichi-lilly-still-no-word-prasugrel/2008-10-17
[15] http://www.fiercebiotech.com/story/fda-delays-review-takedas-alogliptin/2008-10-10
[16] http://www.fiercepharma.com/story/genzymes-myozyme-approved/2008-10-22
[17] http://www.fiercebiotech.com/story/lev-pharma-wins-fda-approval-cinryze/2008-10-13
[18] http://www.fiercebiotech.com/story/watson-wins-regulatory-ok-rapaflo/2008-10-09
[19] http://www.fiercebiotech.com/story/akorn-wins-fda-ok-topical-eye-anesthetic/2008-10-08
[20] http://www.fiercebiotech.com/story/bayer-gets-kogenate-approval/2008-10-13