Medical Device Daily Washington Editor

The Obama administration said 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 regarding 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 Medical Device Daily 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."

BPA bills resurface in Congress

The question of whether bisphenol A (BPA) constitutes a health hazard continues, but Congress is weighing in with the Ban Poisonous Additives Act of 2009, which apparently has not yet been assigned an index number for either House or Senate versions. The bill, which would ban BPA from food and beverage containers, is a repeat of a bill by the same name introduced last year, but its prospects for passage this year may be improved, given the change of party in the White House.

Several national governments are on record on the question, with Canadian authorities indicating that the substance, which has been in use since the 1930s, is toxic. However, the governments in Germany and Japan have concluded that the available evidence shows no definitive link to toxicity. FDA reviewed the matter last year, but in a statement posted at the agency's web site dated Oct. 28, 2008, FDA indicated that "additional research would be valuable" and "is already moving forward with planned research to address the potential low dose effects of bisphenol A." However, the agency's view at that time was also that "the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies."

The fate of the bill is difficult to predict, but any ban of BPA in food and beverage containers could be followed by a similar move in medical devices, mostly in intravenous equipment and containers.

Representatives of Becton Dickinson (Franklin Lakes, New Jersey) and Baxter Healthcare (Deerfield, Illinois) were not available for comment.

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.

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