FDA Food Inspections
Are Seen as Inadequate

JANE ZHANG / Wall Street Journal 17jul2007

WASHINGTON — Congressional investigators are expected to tell a House subcommittee today that the Food and Drug Administration's ability to ensure the safety of the U.S. food supply is "minimal" and agency plans to overhaul its inspection regime could make a bad situation worse.

FDA officials, under fire for the recent string of high-profile food scares involving both domestic and imported foods, have been asked to appear before a House Energy and Commerce investigations subcommittee hearing to discuss the agency's food inspections.

Committee staff reviewed the system extensively and found that a shrinking inspection staff examines less than 1% of all imported food. A typical inspector in the FDA's San Francisco office examines nearly 1,000 food entries a day — roughly one every 30 seconds, the committee report found. The agency, it says, allows importers to take possession of their high-risk goods and arrange for testing by a private laboratory. Before melamine-contaminated pet food killed and sickened thousands of pets, the FDA had never inspected those ingredients from China.

The FDA is trying to reorganize its field operations, but the report says some of its measure may backfire. Only a small percentage of its senior scientists are willing to be transferred if the agency closes seven of 13 laboratories. And in boxes of documents delivered to congressional investigators to explain the reasoning behind the closures, the agency didn't appear to have conducted any cost analysis.

The committee investigators also raise questions about the adequacy of the FDA's mostly voluntary approach to domestic and imported food. Because of lack of authority, FDA inspectors had been refused by some companies to access their records and test results. With the exceptions of several food categories, "FDA has no rules governing testing protocols, record retention...manufacturing, quality assurance and control, or the right to examine any records that a food-processing firm chooses to keep voluntarily," the report said.

The report was based on reviews of documents, interviews with industry experts and current and former FDA employees. Investigators also visited FDA laboratories and field offices.

The report, part of today's hearing, comes as Democrats are critical about how the White House has handled food safety. Funding for the FDA's food program has been stagnant, and the agency's effort to fix problems has been limited by funding shortfalls, bureaucratic delays and lack of political will.

FDA spokeswoman Julie Zawisza said the agency hasn't seen the report, but its senior officials, including Commissioner Andrew C. von Eschenbach, will testify. "We look forward to addressing the issues the committee will raise."

source: p.A9 17jul2007

Congress Expected to
Probe FDA Bonuses

AP 17jul2007

WASHINGTON — The Food and Drug Administration is giving workers more than $8 million in bonuses to keep them from defecting to pharmaceutical and other regulated industries, at the same time the agency is being pressed to spend more on food and drug safety.

The retention bonuses, worth $5,000 or more per employee, are triple what it paid in 2002 and more than any other federal agency pays. As recently as 2005, the FDA accounted for more than 40 percent of the overall $21.6 million the government paid in retention bonuses, according to FDA and other government records.

The retention bonuses are only part of an overall financial incentive program, including recruitment and relocation bonuses paid its employees, that has grown sharply at FDA in recent years. In 2002, the agency gave out just $3.2 million in bonuses worth $5,000 or more. That grew to $9.5 million last year.

FDA officials say the bonuses are necessary to keep vital employees from moving to the private sector; congressional critics say the money would be better spent on improving safety.

The bonuses are expected to be an issue at a congressional hearing Tuesday to examine the FDA's efforts to protect the nation's food supply, as the total nearly matches the additional amount the agency is spending to strengthen food safety next year. A spate of high-profile outbreaks of foodborne illness, including salmonella-tainted snack foods that sickened dozens of toddlers, has drawn scrutiny from Congress.

"Congress puts in extra money in for food safety and what does FDA spend it on? Bonuses," said Rep. Bart Stupak, D-Mich., chairman of the oversight and investigations subcommittee of the House Committee on Energy and Commerce.

FDA food safety center employees receive just a fraction of the bonuses — $265,000 overall last year. Instead, employees in the drugs office, where the agency reviews new drugs seeking federal approval, claim the vast majority, or nearly $5.8 million in 2006.

The FDA has long complained about turnover in its Centers for Drug Evaluation and Review, especially among medical officers. Agency officials contend the incentives help recruit new employees and more importantly encourage veterans from leaving to work for drug companies, universities, law firms and others that value their decades of experience and sought-after technical expertise.

"It allows us to compete in the private sector and it allows us to hang onto people that are going to leave and go to the private sector — so they stay with us a little longer until we get their replacement ready or hire someone else from the outside," said John Dyer, the FDA's chief operating officer.

In most cases, retention incentives cannot equal more than a quarter of an employee's base pay, according to the Office of Personnel Management. However, they can equal up to half the base if the need is critical. Dyer said that even with the bonuses, employees earn 10 percent to 20 percent less than what they could get in the private sector.

In 2005, the most recent year for which data are available, two departments — Defense and Health and Human Services — accounted for $18.5 million of the $21.6 million in retention bonuses paid by the federal government, according to OPM.

While the Defense Department doled out more of the retention bonuses, HHS paid more overall — an amount equal to nearly 55 percent of the government total, or $11.9 million. The FDA, which is part of HHS, in turn accounted for roughly $8.7 million of that.

The FDA has been especially generous with its medical officers, including doctors who help the agency review drug applications. The FDA has long lamented its difficulties in keeping its drug reviewers, whom the pharmaceutical industry routinely poaches. In some years, the FDA has lost as many as one in five of its drug reviewers.

source: 17jul2007