Safety Hinges on Improved Regulation

Posted March 9, 2008 at 10:59pm

As Congress works to address growing health care concerns, ensuring the safety of our nation’s food and drug supply must be a top priority. This requires a strong Food and Drug Administration — one that’s able to fulfill its mission of protecting the health and safety of the American public.

Today, the FDA is responsible for regulating more than $1 trillion in consumer products, or close to 25 cents of every U.S. consumer dollar spent. Though the responsibility is enormous, anything less than effective oversight is unacceptable — and dangerous.

Since last year, when I became chairman, the Energy and Commerce Committee has investigated the safety of the food and drugs that Americans consume every day, as well as the FDA’s ability to ensure the safety of these products. Over the course of our investigation, it has become frighteningly clear that the FDA badly is in need of reform. Without the necessary changes, the health and safety of the American people remains at risk from tainted food and drugs.

FDA’s regulatory efforts have fallen particularly short when it comes to food and drugs imported from abroad. In today’s global economy, 80 percent of active pharmaceutical ingredients used in U.S. prescription drugs are imported from abroad. Yet the FDA’s regulation of foreign drug manufacturers is woefully inadequate. For instance, in 2006, the Government Accountability Office found that the FDA inspected only 15 pharmaceutical producing and pharmaceutical-ingredient producing firms in China, despite the fact that China may now have more than 700 firms shipping drug products to the United States. In fiscal 2007, the FDA inspected just 10 percent of 3,000 foreign drug manufacturers.

The consequences of unsafe drug imports can be tragic, as we recently saw when four people died and hundreds became ill after taking the blood-thinner heparin. Much of this drug’s main ingredient came from a Chinese plant that the FDA had not inspected.

The FDA’s failures are by no means limited to drugs imported from abroad; domestically produced drugs also are at risk. Whether one looks at the increased suicide risk in adolescents from antidepressant drugs, or liver deaths from the drug Ketek, or heart attacks and strokes from Vioxx and Avandia, there are persistent and deeply troubling concerns regarding the FDA’s drug-approval process.

Americans are equally, and justifiably, concerned about the safety of their food supply. As in the area of pharmaceuticals, food imports from abroad have ballooned in recent years and the FDA’s regulatory efforts have not kept up. Today, the U.S. imports more food from abroad than ever before. Yet, frighteningly, the FDA inspects less than 1 percent of imported food at the border, tests just a small fraction of that 1 percent and visits only a handful of foreign food processors each year.

The FDA’s regulation of domestic food also is insufficient. Today, the FDA inspects food manufacturers at most every 10 years. The FDA conducts almost no inspections of retail food establishments and only limited inspections of food-producing farms.

The dangers posed by holes in our food safety net have never been clearer — or larger. Last year was marked by recalls related to: contaminated pet food; peanut butter and pot pies infected by salmonella; botulism in canned food; salmonella in leafy greens and spinach; packaged salads at risk for E. coli; imported Chinese ginger contaminated with a dangerous pesticide; and warnings about dangerous antibiotics in imported Chinese seafood. Clearly, in both the areas of food and drugs, the FDA currently is incapable of carrying out its mission. This paralysis stems from a lack of resources, insufficient staffing and, most of all, inadequate leadership. The Energy and Commerce Committee intends to correct this unfortunate situation through vigorous oversight and legislation.

Unfortunately, the administration has proposed — against its own FDA commissioner’s recommendation — a woefully inadequate increase of $51 million in new budget authority for the FDA in fiscal 2009, an amount that is seven times less than what the members of the commissioner’s own advisory board recommended.

To begin to address these issues, Reps. Frank Pallone (D-N.J.), Bart Stupak (D-Mich.) and I have introduced the Food and Drug Import Safety Act, legislation that would help ensure the safety of food and drug imports. The bill specifically would create a user fee on imported food and drug shipments in order to hire additional personnel to perform inspections at both the U.S. border and abroad. Those importing food and pharmaceuticals into our nation profit tremendously. It is reasonable to expect that they fund the tests to ensure imports are safe.

The committee’s oversight also has prompted the FDA to make some positive changes. I was pleased that the FDA recently announced plans to station inspectors overseas. The need for an overseas presence is one of the key recommendations to come out of the committee’s investigations into food and drug safety to date. Of course, the devil is in the details and the committee will monitor carefully how the FDA funds and implements this proposal.

I am also pleased that, through legislation and oversight, the committee persuaded the FDA to abandon its ill-conceived proposal to close seven of its 13 field laboratories. Now is the time to put more resources in the field, not less.

In that vein, I cannot support proposals that would take the responsibility for food safety away from the FDA. While the FDA has considerable flaws, it also employs some of the most proficient inspectors in our government. The goal of legislation should be to build upon their expertise and provide them the resources they need, not to further weaken this vital agency.

Americans trust the FDA to ensure that the drugs in their medicine cabinets and the food on their kitchen tables are safe. Sadly, as of now, it appears this trust is misplaced. My colleagues and I plan to correct these problems and ensure that the FDA is capable of performing its vital mission. The American people deserve no less.

Rep. John Dingell (D-Mich.) is chairman of the Energy and Commerce Committee.