ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com
FYI
Two reports put the spotlight on the FDA–an agency authorized to regulate “more than $1 trillion worth of consumer goods, which amounts to about 25 cents of every consumer dollar spent in this country. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and
$18 billion in vitamin supplements. The agency is responsible for monitoring a third of all imported goods, from eggplant to eyeliner, microwave ovens to monoclonal antibodies, slaughterhouses to cellphones. But with fewer than 500 import inspectors and computer systems so old that repairmen must be called out of retirement to fix them, the agency is increasingly beset by a sense of futility.”
Writing in the Sunday Magazine, New York Times reporter, Gardiner Harris, reports: “Even the F.D.A.’s staunchest defenders now acknowledge that something is terribly wrong. Among them is Peter Barton Hutt, who served as the agency’s general counsel during the Nixon administration and is widely considered the dean of the F.D.A. bar in Washington. I’ve interviewed Hutt dozens of times over the years, and he has always defended the F.D.A. No more. “This is a fundamentally broken agency,” Hutt told me earlier this year, “and it needs to be repaired.”
“The breakdown is not simply about money. This summer 1,442 people around the country were sickened by tainted tomatoes — or possibly jalepeño peppers. Such scares have become familiar, and the inability to quickly find the sources of contamination has been one of the agency’s signal failures. A
2002 law requires produce processors and distributors to keep track of where food goes and comes from, but the government has yet to mandate standardized record-keeping. As a result, in response to a scare, investigators must pour over a blizzard of contradictory packing slips and incompatible computer programs as they race to save people.”
“The F.D.A. relies almost entirely on its own inspections of foreign plants. This was not much of a problem 30 years ago, when most medical products consumed in the United States were made here and F.D.A. inspectors could drive around to plants in their district. Most of those plants have since
moved abroad, and now decades can pass between inspections. Testifying before Congress in April, Dr. Janet Woodcock, director of the F.D.A.’s drug center, spoke with rare frankness about the ability of the agency to do its job abroad. “The F.D.A. of the last century is not configured to regulate
this century’s globalized pharmaceutical industry,” she testified.”
Furthermore, “The F.D.A.’s apparent inability to keep names straight is no trivial matter. One reason the agency failed to inspect the Changzhou plant that produced deadly heparin, for instance, was that someone mixed up the facility’s name and concluded that the plant had already been inspected.
Chinese plant names, a vestige of its once strictly controlled economy, are often very similar, and translations can vary. For instance, there are 57 separate drug master files — the basic F.D.A. record of a plant’s name, location and approved product — with “Shanghai” in the name. Some are obvious repeats, like the ones for “Shanghai No. 6 Pharmaceutical Factory” and “Shanghai Number 6 Pharmaceutical Factory.” But others could be separate plants. Or maybe not. It’s just too hard to tell.”
More mind boggling still–
How does the Administration and Congressional leadership explain the fact that the FDA still lacks a rudimentary reliable computer system????????
Gardiner Harris reports: “Compounding the problem is the F.D.A.’s antiquated technology. Its computer
systems are so awful that officials have no way of knowing which names, or which plants, are real. To determine which factories need to be inspected, agency investigators must consult two incompatible databases, one of which lists 3,000 foreign drug plants exporting to the United States and the other
6,800. Which number is right? Nobody really knows. Officials have told House investigators that their best guess for the number of foreign drug plants exporting to the United States is 2,967, while the Government Accountability Office recently guessed 3,249. Neither can the agency tell in many cases
when the plants were last inspected (or, more important, which have never been inspected), where they are located or what products they make.”
See: The Safety Gap at: http://www.nytimes.com/2008/11/02/magazine/02fda-t.html
Surely, the United States of America–a nation that spends $10 billion a month on a war the public opposes; a nation that coughs up close to a trillion dollars to bail out banks–which , again the public opposes; surely the US government could afford to provide the FDA with viable computer technology to protect the public health!!!!!!!!!
Jonathan Cantu, of the Government Accountability Project writes (below) that the FDA needs some guts, not PR.
“After the failures of Vioxx, the respiratory drug Ketek, bacteria-laden spinach and a roster of other safety lapses, it’s obvious why the agency is seeking a reputation boost. But this won’t come about through Madison Avenue spin jobs. This PR debacle is a microcosm of the inherent problem at FDA
that must be addressed: Officials are more concerned with limiting bad press and helping corporate friends than with safeguarding public health. There is a clear path to fixing these fatal flaws, but it won’t happen overnight. A new generation of FDA leadership must provide sustained support for
decisions based on sound science rather than politics or the marketing imperatives of drug companies.”
We agree, “a new generation of FDA leadership” is essential if the agency is to return to making science-based decisions–rather than helping increase corporate profitability.
Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974
