EDITOR’S NOTE — An occasional look at how Washington works — or doesn’t.
By RICARDO ALONSO-ZALDIVAR and MIKE BAKER
Associated Press Writers

WASHINGTON (AP) — Tainted peanuts. Unsterilized syringes. Salmonella in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.

Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis. The agency that regulates products worth 25 cents of every dollar spent by U.S. consumers seems overwhelmed by its own mission.

Some say the FDA is broken, and others want to break it up — by moving food safety to a new office.

“You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above,” said Rep. John Dingell, D-Mich., who as the longest serving member of Congress has investigated many agencies, including the FDA.

“Bet yourself a new hat or a fine dinner that you are going to have a scandal a month,” Dingell added. “They are running around like a lot of headless chickens.”

Others, even some critics, see tentative improvements. Many defenders acknowledge the FDA is struggling.

“‘Broken’ is the kind of word that’s sort of a fighting word,” said Dr. Frank Torti, the cancer researcher serving as acting FDA commissioner. “We have recognized for a long time that more is needed. Because of a lack of (legal) authorities and inadequate resources, it’s really hard to do the job.”

Restoring the FDA’s reputation will be a major challenge for an Obama administration that strode into town promising competent government.

The decline didn’t happen overnight. There’s no single, simple cause. In 2007, an independent group of science advisers concluded that the FDA was in danger of failing in its mission. “American lives are at risk,” said their report. It wasn’t the first alarm.

As the pharmaceutical and food industries went global in recent years, the FDA fell behind on inspections. Its legal powers failed to keep up with fast-changing industries. Its own scientists said it grew too cozy with drug companies and tuned out signals of safety problems.

Money for research grew scarce. The agency struggled to answer such seemingly simple questions as how far from a cow pasture a farmer should plant his spinach patch to keep out bad germs. Internal computer systems were allowed to decay, although they are essential to monitoring drug safety trends or blocking shady imports.

The FDA drifted. During the Bush administration, it went long periods without a permanent commissioner who could be an advocate before Congress. Lawmakers piled new responsibilities on the agency, often without the funds to carry them out.

This past year’s safety problems — homegrown and imported — illustrate the FDA’s weakness.

Last winter, heparin from China contaminated by a mysterious ingredient prompted an international recall. The blood thinner, used to treat people during heart surgery and kidney dialysis, was triggering life-threatening allergic reactions.

Summer brought a salmonella outbreak blamed first on tomatoes, and later on hot peppers as well.

This winter, it was salmonella again, in peanut products. A small company’s apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients.

More than 2,100 people were sickened in these incidents. At least nine deaths have been blamed on tainted peanuts alone.

Last week, another problem surfaced. Federal prosecutors in North Carolina obtained guilty pleas from two employees of AM2PAT, a company that manufactured syringes in unsterile conditions and covered it up with phony paperwork.

Prosecutors say hundreds of patients were sickened and five died. The FBI is looking for the company’s owner, who may have fled the country.

Different products were involved in the incidents, but some of the same FDA shortcomings: inspections, legal authority and technology.

The pharmaceutical plant in China that made the heparin was never inspected by the FDA, partly because the agency confused its name with a similar name belonging to another factory. It was unclear how many foreign drug facilities fall under the FDA’s jurisdiction because one government database lists about 7,000 and another, 3,000.

Sending inspectors to China used to involve first waiting for permission from the Chinese government. The situation has improved, under a U.S.-China agreement that led to the opening of FDA offices there.

The tomato outbreak last summer underscored other kinds of gaps. Produce companies are not required to have a food safety plan. And the FDA lacks legal authority to require a system for tracing foods back to the farm. Investigators had to sift through piles of paper records as losses mounted for tomato growers. Dingell said the FDA looked like the Keystone Kops.

In the peanut butter outbreak, the FDA has been slowed because of the length of time it takes to identify positively a strain of salmonella. The agency wants to replace current lab tests that can take a week or more with technology that cuts the wait to a day or two.

FDA inspectors quickly descended on the small Georgia facility at the center of the peanut outbreak. But they didn’t get the whole story immediately. The FDA had to invoke bioterror laws to get lab reports that ultimately showed the company shipped tainted peanuts. Meantime, the agency had no authority to order a food recall.

“The FDA has been trying to do so much with so little for so long that they really have lost the vision of what would make an effective food safety program,” said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, which wants to set up a separate food agency.

Congress has been pumping more money into the FDA the last couple of years. And the Obama administration seems willing to consider big changes, especially on food safety.

The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children’s cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York’s health commissioner.

“One area where we could see bipartisan cooperation might be the strengthening of the FDA,” said Dr. Paul Stolley, a former department head at the University of Maryland medical center who had a stint as a visiting scientist at the FDA. “I don’t think ideological differences should interfere.”

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Baker reported from Raleigh, N.C.

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On the Net:

FDA Science Board report — http://tinyurl.com/yvnk28

Copyright 2009 The Associated Press.

BY SETH BORENSTEIN and BRETT J. BLACKLEDGE
Associated Press Writers

WASHINGTON (AP) — The U.S. government has increasingly relied on food-safety inspections performed by states, where budgets for inspections in many cases have remained stagnant and where overburdened officials are trained less than their federal counterparts and perform skimpier reviews, an Associated Press investigation has found.

The thoroughness of inspections performed by states has emerged as a key issue in the investigation of the national salmonella outbreak traced to a peanut processing plant in Blakely, Ga. The outbreak, which has highlighted weaknesses in the nation’s food-safety system, is blamed for 600 illnesses and at least eight deaths in 44 states.

The House Energy and Commerce investigations subcommittee, which is to hold a hearing Wednesday on food safety, scheduled a meeting Tuesday to issue a subpoena for Peanut Corp. of America President Stewart Parnell, said a senior aide to a member of the panel. The aide, who spoke on condition of anonymity because panel members were still being notified, said Parnell was otherwise refusing to appear at the hearing.

State investigators performed more than half the Food and Drug Administration’s food inspections in 2007, according to an AP analysis of FDA data. That represents a dramatic rise from a decade ago, when FDA investigators performed three out of four of the federal government’s inspections. The Agriculture Department is responsible for meat and dairy safety.

Increased inspection responsibilities have not been accompanied by big spending increases in many states responsible for the bulk of the nation’s food production.

The FDA covers some costs for states to perform inspections. But in Pennsylvania and Ohio, for example, each state’s own food safety spending increased only slightly since 2003, less than the rate of inflation; in California and Massachusetts, just barely more than inflation; and in New Jersey, spending has remained about the same. Those are among states with the largest numbers of food-processing plants.

“It clearly is a passing the buck kind of thing and somebody is dropping the buck along the way,” said Cornell University food safety professor Joseph Hotchkiss.

A Georgia health inspector noted only two minor violations at the Peanut Corp. of America plant in October, and inspection reports indicate officials spent no more than a few hours inside the plant during visits there. But after the FDA became suspicious of the plant’s role in the outbreak months later, it found roaches, mold, a leaking roof and other sanitation problems. The federal agents spent days at the plant.

“To say that food safety in this country is a patchwork system is giving it too much credit,” said Sen. Tom Harkin, D-Iowa, chairman of the Agriculture Committee. “Food safety in America has become a hit or miss gamble, and that is truly frightening. It’s time to find the gaps in the system and remedy them.”

The FDA never followed up on the Georgia inspections because the problems discovered by the state “were considered to be somewhat resolved,” Michael Chappell, head of the FDA’s enforcement division, said during a congressional hearing last week.

The FDA relied on Georgia to inspect the Peanut Corp. plant in Blakely between 2006 and 2008, just as it relies on other states. But Georgia failed to identify problems, even as the company’s own internal testing repeatedly found salmonella in its products and Canada rejected a shipment of its peanuts because of metal contamination.

“Many of these state contract inspections are much briefer, much less intensive inspections than the FDA does,” said former FDA deputy commissioner Michael Taylor, who supports contracting to the states.

Taylor said the FDA doesn’t have enough money to perform its own inspections. But he acknowledges problems with state visits and has urged a dramatic overhaul of federal and state food safety.

The number of federal field food inspectors dropped by more than 400 between 2003 and 2007, according to the FDA’s budget. But the number of businesses requiring oversight increased by 7,200 between 2003 and 2007, according to the Government Accountability Office, the investigative arm of Congress.

“What’s happened is the agency can do fewer and fewer (inspections) itself, so if it’s going to do anything it has to use the states,” said Bill Hubbard, a former associate FDA commissioner who now lobbies for increases in FDA funding. “The states can do it much more cheaply, but the states may not do as it thoroughly.”

Some states, such as New York and Florida, earn high praise among food safety experts for conducting professional inspections. And in some cases, state enforcement laws give state officials more authority than the FDA’s inspectors have under federal laws.

Florida’s food safety director, Dr. Marion Aller, said her inspectors are as good as the FDA’s. But even though Florida recently raised fees it charges for inspections, she acknowledged the state’s food safety budget “has not kept pace with the growth in the industry.”

“We are not inspecting 100 percent of the firms at 100 percent of the desired times,” she said.

In the wake of the Georgia case, food-safety inspections are facing new scrutiny from Congress. The FBI said Monday it has joined the criminal investigation involving the owner of the Georgia plant.

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Associated Press writer Jim Drinkard contributed to this report.

Copyright 2009 The Associated Press.
Summary

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

“The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

“Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the scientists wrote.

FDA spokeswoman Judy Leon said in response: “We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members’ concerns and take appropriate action.”

Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes — which is the agency’s reputation.

The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House.

In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA’s in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.

Top FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along,” the letter said.

A spokeswoman said the Obama transition team had no comment.

Copyright 2009 The Associated Press.