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A clinical research group says that to reduce costs and delays in the drug development process, the FDA should consider fundamentally redesigning the current clinical trial model, including allowing investigational drugs to go to market on a conditional basis.
The final version of the National Institutes of Health’s (NIH’s) plan to fight the obesity epidemic calls for a $400 million commitment this year and a $440 million commitment in 2005 to fund a multipronged approach that combines pharmacologic, surgical, behavioral and other medical antiobesity strategies.
Gov. Arnold Schwarzenegger has sent a letter to HHS detailing two different approaches that he believes would help low-income uninsured Californians buy prescription drugs by forcing pharmaceutical manufacturers to negotiate prices.
HHS and the FDA said they would “vigorously” defend themselves against allegations that the agencies are not acting quickly enough to establish a program that would allow the legal importation of prescription drugs from Canada.
A Democrat on the House Energy and Commerce Health Subcommittee has asked HHS Secretary Tommy Thompson to reconsider his decision to abide by the National Institutes of Health’s (NIH’s) finding that it would not intervene to authorize generic competition with Abbott Laboratories’ AIDS drug Norvir.
An audit report released last week by HHS’ Office of Inspector General (OIG) revealed that a half dozen states overpaid $12.7 million in durable medical equipment (DME) Medicaid claims because their payment systems were not updated to current levels.
Sen. John Kerry (D-Mass.), Democrat presidential nominee, outlined a plan for reducing the cost of prescription drugs that includes negotiating lower prices for federal and state governments and legalizing the importation of Rx drugs.
Estimates for Medicare outlays for the five-year period 2005 through 2009 were increased by $67 billion, the White House Office of Management and Budget (OMB) said in its midsession review of the 2005 budget.
The secretary of HHS has decided he will not overrule the National Institutes of Health’s (NIH’s) decision to deny a request by an advocacy group to break patents on Abbott Laboratories’ AIDS drug Norvir and authorize generic competition, an HHS official said last week.
An average of 195,000 patients died annually from preventable medical errors in hospitals between 2000 and 2002, according to a report by a healthcare quality rating company.