Lawsuits Related to Vioxx Could Affect FDA Approvals of New Prescription Drugs
The Wall Street Journal on Tuesday examined the potential effects that the Vioxx trials could have on FDA's drug approval process, with the industry interpreting the decisions "as a signal of how deeply a sense of caution on drug approvals has taken hold."
In the first two weeks of September, FDA advisory committees will review several "potential blockbuster drugs," including Orencia, a Bristol-Myers Squibb rheumatoid arthritis drug; Exubera, Pfizer's inhaled insulin treatment; Pargluva, a BMS treatment for type 2 diabetes; and Xinlay, a prostate cancer treatment by Abbott Laboratories. If approved, analysts predict potential sales of more than $1 billion for each drug.
Pharmaceutical companies anticipate that FDA and its advisory committees will "rais[e] the bar on approving new drugs," and both drug makers and FDA have begun to look more at drugs' side effects, according to the Journal. However, FDA says approval rates have not slowed.
Deputy FDA Commissioner Scott Gottlieb said the agency has not changed its review process of drugs, but that scrutiny and criticism of advisory committee members -- academic experts who evaluate specific drugs or issues -- could "have a chilling effect on their ability to have a frank and open scientific discussion" (Wilde Mathews, et. al, Wall Street Journal, 8/23).