A New Day for the FDA?

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This is a pivotal moment in the history of the federal Food and Drug Administration.

Almost every month now a new crisis highlights just how difficult it has become for America’s leading public health agency, designed more than 100 years ago, to identify and stop unsafe food, drugs, medical devices and other products before they cause injuries or even deaths.

Last March, for example, there were mounting reports of infections caused by a virulent strain of E. coli, a dangerous food-borne bacteria. The illnesses were linked to Nestlé’s Toll House refrigerated cookie dough. But the recall of some 300,000 cases of the dough did not begin until June 19—after 66 illnesses had been confirmed in 28 states. This E. coli strain can cause a severe complication called hemolytic uremic syndrome, or HUS, which can lead to kidney failure and death. So far 28 people have been hospitalized and seven have been diagnosed with HUS, though no one has yet died.

Shaken public confidence in the FDA

As is so often the case, it took illnesses and a crisis before the FDA could move quickly to get dangerous products off the market.

Today, constant news reports on injuries from products that millions of people eat, drink or use—from tainted spinach and peanuts to a recall of the blood thinner heparin—have shaken public confidence in the FDA. Eighty percent of Americans polled by Harris in the 1970s believed in the FDA’s ability to protect the public health. By 2006, just 36 percent did.

“Everybody at the agency knows we need to do a better job,” concedes Susan Winkler, the FDA’s former chief of staff who left the agency last week. “What we do need that does require wholesale change is an investment in both the resources and the authority of the FDA. … Those two fundamental issues need to be addressed, and then you can evaluate the performance of the agency.”

Now, the Obama administration—with bipartisan support in Congress—appears to be moving to restore and revive the ailing agency. President Obama, who has promised a full review of the FDA, has already asked for a substantial increase in its budget for 2010 even as he named Margaret Hamburg, M.D., an experienced doctor with a history of guarding public safety, to head the agency.

Agency faces trouble

But the FDA’s list of problems is daunting.

Resources, staff shortages, and lack of adequate legal authority share some of the blame. For years the FDA’s congressional appropriation has been only $2.1 billion, less than a quarter of the $8.8 billion that goes to the Centers for Disease Control and Prevention. A raft of reports—from the Institute of Medicine’s 2006 review of the FDA inadequate drug safety systems to the 2007 Science Board report “Mission at Risk”—have called for a “substantial increase” or a doubling of the FDA’s congressional appropriation, and a 50 percent increase in its staff.

To make up what has been the FDA’s chronic budget shortfall, a 1992 law levied fees on prescription drugmakers.

So-called user fees will also be required this year of food makers and tobacco companies, to pay for part of regulation costs. While user fees have provided staff and funding, “the impact on the FDA as an institution is highly destructive,” says Peter Hutt, who studied the user-fee system for the Science Board.

Rich and poor departments

Having the regulated industries help pay for the regulators creates the appearance of a conflict of interest, and has left rich and poor departments within the FDA, says Hutt. New drug review, for example, is well funded. But the FDA’s budgets for surveillance and enforcement of food, drug and medical device safety as well as oversight of imports and inspections come up short. The number of FDA food-safety inspections dropped 47 percent from 2003 to 2006, according to the AP. As for the 18 million shipments of imported goods, maybe one percent is visually inspected—on a good year.

For its part, the FDA’s old guard believes it’s been making the system work as best it can with what money and authority Congress has given it.

But many in Congress and the medical community feel that the FDA’s reliance on crisis management reflects “poor performance as a regulatory agency.” As congressional investigators put it, the agency’s operating style in an increasing complex, global economy “invites catastrophe.”

Joining the criticism, some FDA physicians and scientists have charged that agency senior staff have allowed unsafe and ineffective medical products to go on the market. These FDA scientists wrote to President Obama, and several times to members of Congress, detailing a “culture of wrongdoing and cover-up” by top FDA officials.

The FDA's new commissioner

Now, Hamburg, 53, the former director of the New York City Department of Health, steps into this hornets’ nest to become the new commissioner of the FDA. “One of my priorities coming into this new position,” Hamburg has said in an interview, “is to move the agency into the 21st century.”

She concedes that morale inside the FDA is low. “There’s a sense of having been struggling against considerable odds in terms of lack of resources and other concerns.” But she has also found “excitement to roll up sleeves” and take on new challenges including the regulation of tobacco products, signed into law June 22 by the president, “and the opportunity to strengthen food safety.”

Hamburg gets high marks as both a scientist and an administrator. “I do not recall another FDA commissioner who has come in with a public health background this extensive, and who has also run a large public health agency,” says Peter Barton Hutt, former chief counsel at the FDA.

As health commissioner, Hamburg designed a tuberculosis control program that reduced New York’s TB rate by 46 percent and created a program that increased child immunizations. Later, in 1997 she worked at the federal Department of Health and Human Services, where she created a bioterrorism response plan and led the planning for a flu pandemic.

She is known as a strong, confident leader, someone capable of achieving bipartisan support to get the resources the FDA so badly needs.

Deputy Commissioner Sharfstein

Her deputy commissioner, Joshua Sharfstein, former Baltimore commissioner of health, came on board in March as Hamburg awaited confirmation. With the nation still reeling from an earlier $1 billion peanut recall, Sharfstein immediately ordered a pistachio recall, once Kraft Foods reported salmonella in nuts that had been shipped. Dr. Michael Klag, dean of the Johns Hopkins Bloomberg School of Public Health, described Sharfstein in the New England Journal of Medicine as a “nuts-and-bolts guy. He gets under the hood and makes the system work.”

The new commissioner and her deputy bring new leadership and expertise that may help restore confidence in this vitally important agency—an agency Americans depend on to oversee the safety and effectiveness of more than $1 trillion in products. From medicines to mangoes, makeup to microwave ovens, the products the agency regulates represent about 25 cents of every consumer dollar spent, including more than one-third of all U.S. imports (see box).

FDA critical to older Americans

Although the FDA affects the lives of every citizen, its successes—and particularly, its failures—are critical to the health and longevity of older Americans. “They are the largest consumers of drugs, and the patients who take multiple drugs,” says former FDA Commissioner Jane Henney, M.D., a professor of medicine at the University of Cincinnati. “They are also more susceptible to food-borne illness.” Indeed, at least eight of the nine people who died this year after eating peanut butter tainted with salmonella were over age 59.

Is the FDA’s budget growth big enough?

While recent measures added more than $300 million to the FDA’s 2009 budget, the FDA’s 2010 budget request by the Obama administration is $3.2 billion, a 19 percent increase over 2009. If passed by Congress, this would boost staff, particularly for safer medical products and food safety. But few longtime FDA observers believe this will be enough to completely halt the agency’s downward spiral.

Still, there is optimism in Washington and among many in the medical community that Hamburg and Sharfstein can get the resources the agency needs to do a better job. To do so, the duo will have to tame the FDA’s critics in Congress, get new laws passed to better define and increase the FDA’s authority—particularly over food safety—and persuade lawmakers to open the federal funding taps in this worst of economic times.

Hamburg sees her role as that of advocate with Congress and the public. “The FDA is an extraordinary agency, and it’s been underappreciated,” she says. “I want to restore the luster that the FDA has had, and restore the confidence of the public in the agency.” It’s a tall order. But observers are hopeful that Hamburg might be just the fresh face the FDA needs to bring the agency up to the standard of today’s world, and make it the public health agency Americans believe it should be.

Amanda Spake reports on health and medicine.