FDA: Reduce Radiation Exposure
The Food and Drug Administration has launched an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: CT, nuclear medicine studies, and fluoroscopy. The FDA said it will issue targeted requirements for device manufacturers to develop safer technologies and to provide training to support safe use. In addition, the agency said it will help develop a patient medical imaging history card for patients to track their own medical imaging history and share it with their physicians. The FDA also recommended that professional societies continue to develop diagnostic radiation reference levels for medical imaging procedures and increase their efforts to develop one or more national registries for radiation doses. “The goal of FDA's initiative is to support the benefits associated with medical imaging while minimizing the risks,” Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
Cephalon Reveals M.D. Payments
Drug manufacturer Cephalon said it paid more than 900 physicians for speaking services or consulting in 2009. Most physicians received less than $10,000, while 17 earned more than $100,000, the drug company said in its online disclosure. Although the 2009 figures include only fees for speaking and consulting for Cephalon, the company said it has begun tracking other “items of value” it provides to health care professionals, including meals, educational items, and payments for research studies, and will disclose those online beginning in March 2011. In posting the payments online, Cephalon became the first drug manufacturer to report payments to physicians under a corporate integrity agreement with the Department of Justice. The 2008 agreement resulted from a $425 million settlement of charges that Cephalon marketed three drugs for unapproved uses. Other drug makers will be disclosing payments to physicians under similar corporate integrity agreements.
FEMA to Pay $475 Million to La.
A federal arbitration panel has ruled that the Federal Emergency Management Agency must pay nearly $475 million to replace Charity Hospital in New Orleans, which sustained massive damage in Hurricane Katrina. The panel's decision, which is binding, gave Louisiana nearly all the money it had requested and means the state can afford to build the new $1.2 billion academic medical center it wants to replace Charity Hospital. Louisiana officials had pressed FEMA for 4 years to agree to replace Charity rather than repair the facility, but FEMA had argued that the state could repair the hospital for much less money. The binding arbitration between the state and FEMA was mandated by language inserted into the federal stimulus bill last year by Louisiana Sen. Mary Landrieu (D).
Report: U.S. Not Ready for Attack
The United States is unprepared for a major attack with biological weapons and has fallen behind in its capability to rapidly produce vaccines and therapeutics, which are essential for responding to a biological threat, a congressionally appointed commission said. “H1N1 came with months of warning. But even with time to prepare, the epidemic peaked before most Americans had access to vaccine. A bioattack will come with no such warning,” said the report from the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism. “A revolution in biotechnology continues, expanding potentially dangerous dual-use capabilities across the globe.” The commission gave the government an “F” grade for failing to develop the capability to effectively counter a biological attack.
More Americans Buy GI Drugs
Almost 10% of Americans purchased at least one prescription gastrointestinal drug in 2007, compared with fewer than 7% in 1997, according to the Agency for Healthcare Research and Quality. Total expenses for prescription GI drugs rose from $7 billion in 1997 to $18.9 billion in 2007. The total number of prescriptions filled increased from nearly 78 million in 1997 to more than 158 million in 2007, the report said. The average expenditure for a single GI prescription drug increased from $90 to $120, and the average annual expense per person rose from $386 to $653 for those with at least one GI-related prescription. Those aged 65 years and older were most likely to use prescription gastrointestinal drugs, the AHRQ report said.
FDA Warns Lilly on Promos
The FDA has warned Eli Lilly and United Therapeutics that a Web page and two patient videos were in violation of the agency's promotional rules. Adcirca (tadalafil) is indicated for improving exercise ability in pulmonary artery hypertension patients. The FDA cited the Web page for failing to include any contraindications, warnings, or precautions for the drug, which “misleadingly suggests that Adcirca is safer than has been demonstrated,” said the warning letter. The two patient videos “seriously misrepresent what is known about the efficacy of Adcirca,” the FDA said.