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 David Michaels Weâve been wondering why the US Occupational Safety and Health Administration still hasnât issued new rules reducing worker exposure to silica, beryllium, diacetyl and other well-documented but under-regulated hazards. Now we understand. OSHA is hard at work, using its limited resources to weaken existing standards. OSHA has just issued a proposed rule […]
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. […]
Regulation
Preemption By Preamble â The Bush Administration’s Backdoor Efforts to Kill Law Suits and Protect Manufacturers of Dangerous Products
By David Michaels The federal regulatory system is in shambles. Regulated industries call the shots and career scientists are prohibited from pushing back. With the agencies in retreat, fear of litigation has become an increasingly important mechanism for discouraging bad corporate behavior. Now, âregulation by litigationâ is under attack. Following a Bush Administration edict, a […]
By David Michaels The Bush Administration has gone all out to make sure states play no role in setting health and safety standards. This is not surprising, of course, since many states are far more committed to health and safety protection than the folks who currently run the federal government. Yesterday I talked about California’s […]
The Supreme Courtâs decision in Massachusetts v. EPA was big news this week; Justin Pidot at Gristmill takes an in-depth look at the rulingâs implications, while Kevin Grandia at DeSmogBlog scrutinizes the stances of the parties opposing it. Then, of course, there was Bushâs recess appointment of Susan Dudley to head the Office of Information […]
When President Bush nominated Susan Dudley to head the Office of Information and Regulatory Affairs (OIRA) last year, her nomination didn’t make it out of the Senate committee. (See Celeste Monforton’s post on Dudley’s underwhelming performance before the committee.) Yesterday, Bush avoided Senate opposition by giving Dudley a recess appointment. As head of OIRA, Dudley will […]
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 […]
By David Michaels The Wall Street Journal (sub required) is reporting that the White House will bypass the Senate confirmation process and announce later today that President Bush has given a recess appointment to Susan Dudley to head the Office of Information and Regulatory Affairs (OIRA). The office, part of the Office of Management and […]
By David Michaels The campaign by policy experts to have Congress end the user fee system that funds FDA is picking up steam. The Prescription Drug User Fee Act (PDUFA) allows FDA to collect money from drug makers in exchange for faster reviews of their new products. But PDUFA makes the FDA dependent on the […]