After months of refusing to say how much the agency needs to get things done, FDA commish Andy von Eschenbach has writte a letter to Congress asking for an immediate infusion to inspect imported food, drugs and devices,The New York Times reports.
The request was made in a letter to Senator Arlen Specter, a Pennsylvania Republican, and offers a detailed spending plan for such things as opening new foreign offices, increasing inspections and constructing new databases to track drug hazards, the paper writes. Here is the letter.
Presidential appointees rarely diverge so forcefully from the president’s own spending plans, or at least avoid doing so in writing. Andy’s action surprised some observers and was taken as perhaps a sign of Bush’s waning influence in the closing months of his presidency. “In 30 years at the agency, I never saw anything like this happen before,” William Hubbard, a former deputy FDA commish, tells the Times.
In February, Bush asked Congress to provide the FDA with an allocated budget for fiscal year 2009 of $1.77 billion, which included an increase of $50.7 million over the prior year, which isn't enough to cover increased agency salaries, the paper reminds us.
On May 1, Specter wrote Andy a letter asking Andy to detail how much the agency needed “to protect the public’s health.” In a handwritten aside in the letter’s margin, Specter wrote, “Andy, I know the situation is extreme. I want to get you financial help now.”
In a May 5 response, Andy wrote that he was providing his budget request “without regard to the competing priorities that the agency, the president, and their advisors must consider as budget submissions to the Congress are developed.”
Julie Zawisza, an FDA, says Andy was simply responding to a request for info from a senator. “These resources will accelerate the changes required for FDA to protect and promote the health of all Americans in a rapidly changing world that poses new, emerging threats to the safety of food and medical products,” she tells the paper.
Ever since the Bush budget proposal, Andy has suffered bipartisan criticism, following scandals over tainted Heparin and food that have produced calls for more foreign inspections of foreign plants.
At a House Energy and Commerce Subcommittee on Investigations hearing last month, Andy was chastised by John Dingell, a Michigan Democrat who chairs the commerce committee, for not providing a figure needed to inspect imported goods. “You cannot do your job, you are not doing your job, how much money do you need to do it?” Dingell chided him. Andy answered: “That would require me to give you a business plan.” (Back story here).
In the Senate a week earlier, Robert Bennett, a Utah Republican, asked the same thing, the Times notes. Andy refused to give a number, but he did say that the agency could not efficiently absorb a $375 million increase in its budget next year. In his letter to Mr. Specter, however, Andy says the FDA could absorb an additional $275 million in just the next few months.
Last week, Herb Kohl, a Wisconsin Democrat who chairs the Senate appropriations subcommittee with jurisdiction over the FDA, sponsored a measure to provide an extra $275 million this year as part of an emergency supplemental appropriations intended to finance the war in Iraq, the paper writes. This may be the only way to provide extra money to the FDA, since appropriations bills for next year may stall.
Kohl’s bill mirrors Andy’s letter to Specter. Both call for $125 million to finance food safety activities; $100 million for medical product and drug safety activities; $40 million for modernizing the science and work force; and $10 million to upgrade agency facilities and laboratories.
Advocates for increased food and drug oversight said they were thrilled. “We are one step closer to an F.D.A. that has the resources to serve the needs of American consumers,” Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, tells the Times.
Told of the letter, Dingell wondered “why the commissioner is beginning to finally recognize what has been painfully obvious to everyone else,” he tells the Times. “This is similar in enlightenment to when St. Paul got knocked off his mule by a bolt of lightening on the road to Damascus.”