Drug firms feeling sting of tougher FDA - Triangle Business Journal:

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Pozen investors reacted as if the drug had been sendingthe company's shares down by 60 But investors in pharmaceutical companies had better get used to the fact at least for now, drugs are facin more rigorous scrutiny on the way to approval. Stun by widespread criticism after the withdrawalof Merck'd pain medication Vioxx in Septembere 2004, the FDA has tightened regulatory conditions. Drug industry executivess say the FDA is approving only those drugs that are clearly superiorf to competitors or those that are targetesd at an unmetmedical condition. In Inspire Pharmaceuticals got an approvable letter for its diquafosoll tetrasodiumophthalmic solution.
Subsequent to a meeting with the FDA in Inspire executives said they plan to give additiona data tothe FDA. In April, Salid Pharmaceuticals received an approvable letter from the FDA forits pre-colonoscopgy treatment MoviPrep. The FDA wanted some manufacturinb deficiencies be corrected before the drug coulcbe approved. Salix has since refilee its application. While additional trials may result insafetr medicines, drug company executivess are not happy about the situation.
A singlse additional trial can add millions of dollard toa company's costs, says Mark Sirgo, chief executivew of , a Morrisville companu that was told in May to returnb with more data for its treatment for nausea and vomiting. "j do think that post-Vioxx, the environment has gotten more saysMarc Shapiro, an attorney with the Durham office of Hyman, Phelps & McNamara, a law firm that handles FDA work for drug The FDA's requirements can range from orderingt larger patient trials to asking for more extensive developmeng plans. A big concernb for the FDA seems to bea drug'w safety record, says Joshua Baker, chief executive of , a Cary drug developmentt firm.
Kimberly Rawlings, a spokeswoman for the FDA, wouldr not comment on specifics, saying only that "the FDA drug review procesz is appliedconsistently ...." While they're grumbling now, most drug industryu officials think the phase is a passing one and that the FDA at some pointf will relax its stance.