New Focus on Drug Safety Slows Drug Approvals

As regulators work to impose requirements meant to minimize the side effects of medications, a new focus on drug safety is delaying the approval of some new medicines.

In an effort to improve drug safety oversight, last year, Congress passed a new law giving the FDA more money and authority over drugmakers.

“That’s taking a considerable amount of time on every new application. The process will streamline and go away over time,” according to a statement Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in an interview with Reuters.

Generally speaking, drug decision dates come six or ten months after a drugmaker has filed an application and are considered goals but not solid deadlines. Managers have been granted discretion to miss some drug approval dates if needed.

Since March, the agency has been hiring more staff to go through the backlog of new drug applications. 

Industry analysts speculated Woodstock’s return to lead up the FDA’s drug division would help move along drug approvals after what many saw as a slowdown following Merck & Co’s 2004 withdrawal of the popular arthritis drug, Vioxx. 

The FDA has been criticized as being slow to respond to problems with medications such as Vioxx, which Merck withdrew after research discovered the drug more than doubled heart attack and stroke risk in patients.

Following the revelation that a Chinese plant that made contaminated heparin had never been inspected, Janet Woodcock announced, earlier this month, that there were 332 inspections of foreign plants in 2007, more than ever before in agency history.   

The FDA is concerned about clinical trials being conducted outside of the U.S., but has not  allocated more funding for clinical trial inspections.  

A report issued late last year by an expert panel concludes that the FDA, so often portrayed as the final safety net that ensures the safety of the American food and drug supply, is broken.

The 56-page report entitled,  "FDA Science and Mission at Risk,"  basically concludes that the agency is putting American lives at risk by cutting inspectors overseas and domestically. It called on Congress to increase funding to the FDA.    #