Von Eschenbach Confirmed for FDA
Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach was finally confirmed by the Senate by an 8011 vote in the wee hours of the 109th Congress. Confirmation came after an 896 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), who has been one of Dr. von Eschenbach's most vocal critics. As chairman of the Finance Committee, he and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. "I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch," the senator said.
FDA Warns on Topical Anesthetics
FDA is warning that topical anesthetics being compounded by five manufacturers may contain high-potency lidocaine, tetracaine, benzocaine, and prilocaine. Patients may experience seizure, irregular heartbeat, and even death when exposed to the agents for long periods or over broad skin areas. Small children and patients with heart disease or severe liver disease are most at risk, said the FDA. Because the drugs are compounded, they are not reviewed by the FDA for safety or effectiveness. However, the five companiesTriangle Compounding Pharmacy, Custom Scripts Pharmacy, Hal's Compounding Pharmacy, University Pharmacy, and New England Compounding Centerare acting like drug makers, because they are compounding standardized versions of FDA-approved and commercially available anesthetics for general distribution, rather than formulating them to meet individuals' needs, said the agency. Two deaths have been connected to anesthetics compounded by Triangle and University, said the FDA. It said its warning should serve as a caution to other companies compounding standardized anesthetic creams. The topical anesthetics are often used as a numbing agent before laser hair removal, tattooing, and skin treatments.
Public NPI Directory Possible
The Centers for Medicare and Medicaid Services is considering publishing a directory of physicians who have National Provider Identifiers. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated that all providers who submit claims or conduct other transactions subject to the law must have an NPI by May 23, 2007. However, the law did not allow for a directory of NPI providers to be published. Physicians have said that such a directory helps facilitate referrals. Medicare's Practicing Physicians Advisory Council has endorsed the idea of publishing a directory. At a PPAC meeting in December, Dr. William Rogers, director of the Physicians Regulatory Issues Team at CMS, said that the agency agreed and that it would pursue development of an online directory for physicians and their office staff.
Poll: No Off-Label Use
About half of Americans said physicians should not be allowed to prescribe pharmaceuticals for unapproved uses, according to a recent
Medicare Advantage Costs More
If the incoming Democrat Congress is looking for funding to expand the Medicare drug benefit, Medicare Advantage may be a ripe target, according to an analysis from the Commonwealth Fund. Researchers at the Commonwealth Fund estimate that in 2005 the federal government paid private Medicare managed care plans, known as Medicare Advantage plans, an average of $922 more per enrollee than comparable beneficiaries would cost under the traditional fee-for-service program, for a total of $5.2 billion. "Medicare should carefully examine whether extra payments to Medicare Advantage plans are the best use of dollars," Commonwealth Fund President Karen Davis said in a statement.