 By Susan F. Wood, PhD  Two things appear to be major bones of contention in determining the final version of what is now named the “FDA Revitalization Act of 2007” (FDARA). And they both related to public transparency and public accountability.Â
 By Susan F. Wood, PhD In an article in the New England Journal of Medicine today, Sheila Weiss Smith points out that the FDA has not been responsive to the Institute of Medicine (IOM) report on Drug Safety. That study and its recommendations took on the question of how to improve our nation’s drug safety […]
 By Susan F. Wood, PhD  The Journal of Womenâs Health published a special report and an editorial last month on the FDAâs Office of Womenâs Health (FDA OWH) that provide information and insight into the multiple roles of such an office, and the importance of maintaining the scientific research funded there. The special report, âThe […]
The Boston Globe, home town paper of Senator Ted Kennedy, Chair of the Senate Health, Environment, Labor and Pensions Committee, ran two important commentaries on the FDA this week.  First was an editorial  yesterday strongly urging Congress to pass a strong FDA reform bill, including restricting financial conflicts of interests for advisory committee members. Today the […]
This week, Congress has been wrestling with the reauthorization of the Prescription Drug User Fee Act; Merrill Goozner at GoozNews reports from Capitol Hill about the questions that FDA Acting Deputy Commissioner for Policy Randall Lutter couldnât answer at a hearing and about the provisions that should be in the bill but arenât. Matt Madia […]
By Susan Wood The recent study in the NEJM clearly points out that our drug safety system is in need of repair. We shouldnât need these constant reminders, from Vioxx to Ketek and now to Avandia. Indeed FDA reform legislation is moving through Congress as we speak. But does it do what we need it […]
When you go to the Department of Motor Vehicles and pay your fee to register your car, are you allowed to negotiate with the DMV as to how the agency will use your fee? Of course not. So why is the drug industry allowed to negotiate with the FDA about how the agency will use […]
The FDA certainly wasnât the biggest newsmaker this week, but it did create some buzz in the blogosphere â mostly due to the Prescription Drug User Fee Act, or PDUFA, which is up for Congressional reauthorization. Matt Madia at Reg Watch and Merrill Goozner at GoozNews are tracking PDUFAâs progress through the Senate. Corpus Callosum […]
By Susan Wood Next week both the Senate and House are moving forward on legislation to reauthorize the Prescription Drug User Fee Act (PDUFA), along with other key FDA legislation. The Senate will be âmarking upâ a large omnibus piece of legislation that combines PDUFA with drug safety legislation, pediatric legislation, and medical device legislation. […]
By David Michaels The Prescription Drug User Fee Act (PDUFA), through which the FDA collects money from drug makers in exchange for faster reviews of their new products, gets skewered again â this time in a piece by Christopher Moraff in the American Prospect Online. (We’ve been covering the issue here at TPH; more materials […]