The Food and Drug Administration has been in the spotlight lately because of problems in two of its most important areas of responsibility: making sure that the nation’s food supply is uncontaminated and that its prescription drugs are safe.
The recent outbreak of E. coli infections linked to California-grown spinach has exposed weaknesses in federal food safety regulation.
Separately, a blue-ribbon panel of the Institute of Medicine has found serious gaps in the way the FDA monitors prescription drugs to catch rare but potentially deadly side effects that come to light only after medications are on the market. The institute is part of the National Academies, which advise the government on scientific and technical issues.
Question: How can one federal agency have so many problems in its lap?
Answer: The FDA’s regulatory responsibilities are vast, while its budget and staff have been squeezed in recent years. The agency is responsible for products that account for a quarter of all consumer spending, including fresh and packaged foods, prescription drugs, medical diagnostic machinery and devices such as pacemakers. It even covers pills for pets and farm animals.
And when something goes wrong with an FDA-regulated product, people are often directly harmed, sometimes killed.
Q: Some say the FDA overreacted by warning consumers not to eat any fresh spinach when the search for contamination focuses on a few fields. Did the agency abuse its power?
A: A warning against eating any fresh spinach may be a blunt instrument, but FDA officials said they had to take sweeping action quickly because initially they couldn’t be sure how widespread the problem might be. And the early cases included one death.
Q: So why didn’t the FDA prevent the E. coli contamination?
A: Spinach and other farm produce is not as closely tracked and regulated by the government as are meat and poultry, which are overseen by the Department of Agriculture. The FDA’s system for ensuring that farm produce is safe rests on voluntary adherence to good agricultural practices by growers, packers and shippers. By comparison, meat and poultry producers must follow mandatory federal food safety regulations.
And although meat plants have an on-site inspector, other FDA-regulated producers can expect to see an inspector once every five to 10 years, on average.
Q: Will the government now put an inspector in every spinach field?
A: No, but FDA officials have indicated that some kind of closer regulation may be needed. The final form could take months to work out. Industry would be closely involved, because federal regulations are usually developed from standards that companies are already employing. Mandatory standards for spinach, lettuce and other leafy greens may not only benefit consumers, but could also serve to protect companies that follow sanitary practices.
Q: What about prescription drugs? Doesn’t FDA approval mean that a medication is “safe and effective”?
A: Maybe that language should have an asterisk. What it means is that a drug is safe and effective as far as the FDA knows from data available at the time of approval. Prescription drugs are usually tested on a few thousand volunteers at most, and the volunteers are often fairly healthy. The U.S. patient population can be quite different; it includes patients who are very sick and people taking many other medications. Also, rare but potentially serious side effects may not emerge in discernible numbers until several hundred thousand patients have taken a medication.
Q: Would adding that asterisk take care of the problem?
A: It would be a start. The Institute of Medicine panel found that the FDA devoted too much energy and resources to studying drugs before approval, and not enough to monitoring the medications once they were on the market. The panel recommended what amounts to conditional approval for new prescription drugs, with a special symbol to denote their newness and with advertising restrictions for two years after approval.
It also said the FDA needed to greatly increase the number of scientists who follow post-approval safety, and it recommended that Congress grant the agency powers to compel drug companies to carry out additional tests on approved medications.
Q: Is there any link between the FDA’s drug and food safety problems?
A. There seem to be two links: lack of leadership and lack of resources.
The agency, frequently the focus of political controversy, has been under acting commissioners for most of the Bush presidency. The Texas cancer surgeon who now heads the FDA, Andrew C. von Eschenbach, is seen as a capable leader, but his confirmation by the Senate is up in the air. An acting chief can keep the wheels turning but generally lacks the clout to make major changes.
As for resources, an internal FDA analysis found that funding for its food and drug safety responsibilities had not kept pace in the face of rising personnel costs in recent years. In the food division, the number of staff in field offices has decreased from 2,217 in 2003 to 1,962 currently.
Some outside advocates, representing consumer groups and industry, have suggested the government may need to double the FDA’s $1.5-billion annual budget. (The agency receives an additional $400 million in user fees from drug companies that submit products for approval.)
Q: Will that happen?
A: Chances are slim of getting that much money at a time when the military is fighting in Iraq and Afghanistan, and when the government is also running substantial budget deficits. Next year, Congress must renew the law that governs FDA user fees, and these issues will be joined in earnest then.