Diagnostics & Imaging Week Washington Editor

The Obama administration reported over the weekend that it is nominating Margaret Hamburg, MD, for the job of FDA commissioner and Joshua Sharfstein, MD, as deputy commissioner, putting to rest months of speculation over who would take the jobs. The March 14 announcement indicates a greater focus on the part of the Obama administration on food safety than on regulation of drugs and devices, which would not have been the case had the White House tapped Cleveland Clinic (Cleveland) cardiologist Steven Nissen, MD, for the commissioner's job, which had been rumored for weeks.

The March 14 announcement, which was posted at the web site for the White House, quotes President Obama as saying that "in recent years, we've seen a number of problems with the food making its way to our kitchen tables," and that "many of the laws and regulations governing food safety in America have not been updated since they were written in the time of Teddy Roosevelt."

The statement includes the observation that because "our system of [food] inspection and enforcement is spread out so widely among so many people that it's difficult for different parts of our government to share information, work together, and solve problems," but Obama also mentions that FDA "has been underfunded and understaffed in recent years."

The statement notes that Hamburg "was one of the youngest people ever elected to the National Academy of Sciences' Institute of Medicine" and that as the health commissioner for New York City, she "brought a new life to a demoralized agency, leading an internationally-recognized initiative that cut the tuberculosis rate by nearly half, and overseeing food safety in our nation's largest city."

Obama said that as the health commissioner for the city of Baltimore, Sharfstein "has been recognized as a national leader for his efforts to protect children from unsafe over-the-counter cough and cold medications" and "designed an award-winning program to ensure that Americans with disabilities had access to prescription drugs."

The White House also took the opportunity to announce the formation of a new food safety work group that will "bring together cabinet secretaries and senior officials to advise on how we can upgrade our food safety laws" and "a billion-dollar investment" in food safety, "a portion of which will go toward significantly increasing the number of food inspectors."

Former FDA commissioner Bill Hubbard told Diagnostics & Imaging Week that he sees Hamburg and Sharfstein as good picks because their resumes suggest that they're up to the task and because their resumes do not set up a conflict with drug and device makers. "The reporting has been that Nissen was critical of industry," Hubbard noted, which he said may have led to some headwind for that nomination. "You have to think Nissen would have had some opponents," he remarked.

Hubbard, an adviser for the Alliance for a Stronger FDA (Silver Spring, Maryland), said "there are those who will say that any Democratic choice" will be anti industry, "but I don't see either of their backgrounds indicating that. Peggy Hamburg is highly qualified," he said, and "she brings no baggage since she has not been a big player in the food and drug world."

"What people look for is whether these people have worked for industry or whether they've been hostile" toward industry, Hubbard said, noting that neither description fits either candidate readily.

By at least one account, the White House vetted the nomination fairly effectively, at least in political terms. Sen. Ted Kennedy (D-Massachusetts), chairman of the Senate Health, Education, Labor and Pensions Committee, which has jurisdiction over FDA nominations, said in a closely-timed March 14 statement that Hamburg "is a strong leader and respected health professional and she's an excellent choice to put the nation's food and drug safety agency on the right course." Kennedy stated further that she and Sharfstein "will bring dynamic new leadership to an agency that sorely needs it and will return sound scientific judgment to the FDA."

New HHS office to oversee ARRA funds

The Department of Health and Human Services (HHS last week opened a new office to help ensure the timely, organized and transparent distribution of the $137 billion the agency is receiving through the American Recovery and Reinvestment Act (ARRA).

The Office of Recovery Act Coordination (ORAC) will be led by Dennis Williams, a 20-year HHS veteran.

HHS spokeswoman Jenny Backus said ORAC will enhance and streamline efforts to "get critical resources and potential new job opportunities to the American people during tough times."

HHS already has distributed more than $3 billion of ARRA funds to states to support a variety of policies and programs, including community health centers and Medicaid, Backus said. "HHS is committed to moving quickly and carefully to distribute Recovery Act funds in an open and transparent manner," she added.

The National Institutes of Health last week said $1.5 billion in ARRA grants was now available: $1 billion for construction and improvement of research facilities, $200 million for scientific research, and $300 million for the purchase of scientific equipment.

The Obama administration earlier this month released $155 million of ARRA funds for community health centers and last month made $15 billion available to states for Medicaid programs.

CMS opens analysis for HIV screen

The Centers for Medicare & Medicaid Services announced last week that it will undertake a national coverage analysis for screening for the human immunodeficiency virus (HIV).

According to the March 13 announcement, the idea originated at CMS based on a set of guidelines published by the United States Preventive Services Task Force, which CMS says has strongly recommended" such screening. The notice states that CMS is "especially interested as to the types of studies needed if the evidence is determined to be premature for coverage or if the appropriate frequency interval [for testing] is uncertain."

CMS states that the public comment period will run until April 12 and that the agency will publish a proposed decision memo by Sept. 13. The process should be wrapped up by Dec. 12, CMS says, if all goes according to plan.

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