The U.S. Army is probing payments by pharmaceutical companies to military physicians in the wake of a recent settlement between Novo Nordisk and the Justice Department over charges that the drugmaker "illegally promoted" its hemophilia drug, reports Pharmalot.
In that case, Novo Nordisk was accused of promoting its NovoSeven medication for unapproved uses such as blood trauma, intercranial hemorrhage and other surgeries by making payments to influential military physicians and personnel. Such off-label use was illegal and dangerous, said the settlement, and while it was helpful to reduce the amount of blood transfusion needed in trauma patients, it did not prolong life. In some cases, the payments were disguised as educational grants by being channeled through nonprofits.
As part of the settlement, the drugmaker paid $25 million and signed a corporate integrity agreement, which is closely monitored by the Justice Department. Such off-label marketing by drugmakers has resulted in multi-billion-dollar settlements in recent years between large pharmaceutical companies Pfizer and Merck and the Justice Department.
The use of NovoSeven has been defended by some military physicians, who insist that it's safe and useful in treating trauma patients.
The command stated in a release saying, “the Army surgeon general and commanding general United States Army Medical Command re-opened the AR 15-6 investigation to include a systematic review of honoraria in the medical research environment.”
The Army had put its investigation of the incident on hold during the Justice Department probe.
Oversight of Disaster Pipelines Was Guided By Industry-Funded Studies
The operators of the nation's 2.3 million miles of pipelines carrying natural gas shaped and provided funding for numerous safety studies conducted by the federal agency that regulates the industry, reports the San Francisco Chronicle. Those studies, run by the federal Pipeline and Hazardous Materials Safety Administration, help guide national and state safety rules and procedures for those pipelines.
Three deadly accidents in the past three years involved decades-old pipelines that might have been replaced -- saving lives -- had the outcomes of the federal agency's research, and the policies they influenced, been different.
CPR For TBTF
How do you resuscitate a too-big-to-fail bank that is near collapse?
That is the subject of an all-star panel Tuesday assembled by the Federal Deposit Insurance Corporation's Sheila Bair to advice the agency on the issue. Among the attendees: former Fed chairman Paul Volcker, MIT economist Simon Johnson and former Citigroup chairman John Reed. Bair said the panel “brings together some of the best and brightest minds to augment the groundwork that the FDIC has already put in to place to handle an extremely large and complex failure,”
Other items on iWatch News's useful Financial Reform Watch this week: a SEC vote on Wednesday on whether to require hedge fund advisers to register with the agency and a House Oversight Committee hearing the same day on the implications of the GM bailout.
FDA Goes Global To Handle Flood Of Imports
The Food and Drug Administration unveiled on Monday a new global strategy to address the challenges posed by rising imports of food, drugs, vaccines and medical devices amid a highly complex global supply chain.
“Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” said Commissioner of Food and Drugs Margaret A. Hamburg in a release. "There has been a perfect storm - more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented."
Part of the strategy involves building international coalitions of regulators focused on product safety and quality and building data systems to help share information about these products. Among the agency's new mandates -- inspecting more than 19,000 foreign food facilities in 2016.
Salazar Expected To Ban Uranium Mining For 20 Years
It's widely expected that Interior Secretary Ken Salazar will announce on Monday a new long-term ban (up to 20 years) on uranium mining. In a midday press conference at the Grand Canyon, he will address the controversy over the boom -- there was a 2,000-percent increase in new mining claims in the Grand Canyon area between 2005 and 2009, reports the American Independent.
Since the U.S. relies on imports of uranium to fuel the nuclear industry, Salazar has been under pressure to drop the ban, but the Japanese nuclear disaster changed that calculus.
More Cops On The Wall Street Beat
The number of regulatory cops on the beat on Wall Street is growing fast, reports the Wall Street Journal.
The New York Federal Reserve has about 150 regulators -- or regulatory "embeds" -- working at Bank of America, Goldman Sachs, Morgan Stanley, JPMorgan Chase, Deutsche Bank among others and that number is expected to double by this fall.
And the Office of the Comptroller of the Currency has about 500 bank examiners working on location at big banks -- and that number is expected to rise by 10 percent. From the Wall Street Journal:
"Regulators have inspected their companies for safety and soundness, financial performance and the quality of management and directors for decades. The on-site reviews are thorough and can produce friction between the bank examiners and their subjects, according to bankers and regulators. The Fed's latest how-to "Commercial Bank Examination Manual" is 1,808 pages long, and examiners have the power to "review all books and records maintained by a financial institution."