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 An editorial in the latest issue of Nature takes up a problem that public health advocates have been battling for years: confidentiality orders that keep important scientific data hidden from the public, scientists, and even regulatory agencies. One recent case of such data being kept secret, which Nature reporter Jim Giles covers […]
 Among the victims of the tragedy at Virginia Tech were five faculty members: James Bishop Jocelyne Couture-Nowak Kevin Granata Liviu Librescu G.V. Loganathan Librescu was a 76 year-old Holocaust survivor who blocked his classroom doorway from the gunman while his students leapt to freedom. The Roanoke Times has profiles of all the victims here.
Scientific Integrity & Ethics
Was NIHâs Contractor Conflicted? And Does It Make a Difference? The Controversy Continues
By David Michaels The controversy continues over NIHâs review of Bisphenol A (BPA), and the agencyâs firing of Sciences International. Members of the NIHâs BPA Expert Panel have joined the discussion, through comments to the Pump Handle, assuring the public that their work was not not influenced by any potential conflicts. In addition, todayâs Washington […]
By Dick Clapp Opponents in the debate over conflict of interest in cancer research are duking it out, and the current forum for their fight is the American Journal of Industrial Medicine. The article that touched off this particular scuffle was âSecret Ties to Industry and Conflicting Interests in Cancer Research,â by Hardell L, et […]
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 David Michaels The National Toxicology Program (NTP) has fired Sciences International. Last month, Marla Cone wrote in the Los Angeles Times about allegations that the consulting firm, hired by the NTP to run the Center for the Evaluation of Risks to Human Reproduction (CERHR), had significant conflict of interest. The allegation was that Sciences […]
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. […]
The owners-operators of the Kentucky Darby Mine No. 1, Ralph Napier, Connie G. Napier, and John D. North, were assessed a $336,000 penalty by the U.S. Mine Safety and Health Administration (MSHA) for violations related to the May 20, 2006 explosion and death of five coal miners. Press reports indicate that MSHA officials met for four […]
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 […]