FDA Expected To Approve Fewer Prescription Drugs In 2007

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Pharmacy / Pharmacist
Article Date: 06 Nov 2007 - 10:00 PDT

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Dow Jones on Thursday examined how 2007 "is shaping up to be a slow year" for launches of new medications. FDA this year likely will approve 18 new medications, compared with 22 in 2006 and 20 in 2005. According to Dow Jones, although FDA has made no systematic changes in the review process, some observers maintain that the agency is "holding back on new drug approvals due to a greater emphasis on safety concerns" since Merck withdrew its COX-2 inhibitor Vioxx from the market in 2004 because of a link between the medication and increased risk for cardiovascular events.

Other observers maintain that the "industry itself simply has failed to come up with enough innovative new products, despite billions of dollars spent on research," Dow Jones reports. In response, some pharmaceutical companies have begun "taking steps to increase the chances experimental therapies will get the FDA green light" by "shifting the focus of research efforts to diseases that are difficult to treat, such as cancer and Alzheimer's, and running longer trials to more fully vet potential side effects of drugs," according to Dow Jones.

Some pharmaceutical companies also have changed their research and development processes. However, "industry watchers say more change is needed, and it could be years before it's known whether the changes were the right ones," Dow Jones reports. Kenneth Kaitin of the Tufts Center for the Study of Drug Development said, "Small tweaks to the R&D paradigm aren't going to suffice," adding, "The industry needs a radical overhaul in the way they approach drug development" (Loftus, Dow Jones, 11/1).

Dow Jones on Thursday also examined how several small and medium-sized pharmaceutical companies "have been caught off-guard by what's seen as a tougher stance by the FDA" on approvals of new medications (Georgiades, Dow Jones, 11/1).

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