Debate on regulations, inspection should focus on food, medicine
Republicans in Congress made headlines over the summer protesting that excessive regulation was killing small business and hurting job creation. And while it’s true that excessive regulation is sometimes a problem, it’s also true that inadequate regulation or inspection is also a problem — a problem that actually does kill, people.
Finding the right balance of regulations, as well as inspections, and cost is the challenge. It can’t solved with sound bites or campaign rants.
The most recent example illustrating this issue is the outbreak of fungal meningitis that has killed 23 people and sickened 300 others. The deadly illness has been traced to a specialty drug-making company, known as a compounding pharmacy. The company, located near Boston, produced 17,000 vials of a steroid that was injected into people suffering from back or neck pain.
The issue in this case is that the federal Food and Drug Administration regulates major pharmaceutical companies, but compounding pharmacies are a special category of drug-maker regulated by states.
Historically, compounding pharmacies have been small operations, often community pharmacies that produce custom mixes of drugs for patients in cases where big drug makers did not produce the product because the market was too small.
But the New England Compounding Center, the company that produced the tainted steroid, had grown to be a large factory, producing drugs much like a major pharmaceutical company, but avoiding FDA inspection because of the loophole for compounding pharmacies.
While small-scale compounding pharmacies might still deserve special treatment, large-scale operations like the New England Compounding Center, should be subject to FDA regulation and inspection.
Before the tainted steroid case began making news this fall, the issue of regulation or inspection failure was raised by contaminated food that had killed people.
Last summer, 33 people died after eating cantaloupe grown by a Colorado farm. It was the deadliest case of food-based disease in nearly a century.
The Centers for Disease Control and Prevention estimates that about 48 million Americans are sickened by contaminated food each year. About 3,000 Americans die from eating contaminated food each year and another 128,000 are hospitalized.
In 2011, there were 37 recalls of contaminated fruits and vegetables, a substantial increase over the 2 food recalls in 2005.
According to a report by Bloomberg Markets magazine, just 6 percent of the food producers in the United States were inspected in 2011. In that same year, less than half of one percent of food importers were inspected.
Because the FDA lacks adequate staffing for inspection, the food industry contracts with private, for-profit inspectors, called third-party auditors. But the Bloomberg report on foodborne illnesses noted that those inspections often are suspect, involve no government supervision and sometimes only cover areas that the clients have asked to have examined.
A professor of food safety at Kansas State University said, “the third party auditor stickers and inspections are meaningless.” He added that Americans are at risk whenever they go to the grocery store.
No doubt, the vast majority of food and produce in American supermarkets is safe, but the incredible array of food suppliers, including many international growers and processors, presents a huge challenge to federal food safety regulators.
House Republicans have blasted the harm caused by wasteful, excessive and truly stupid regulations. And in July, the White House, seeking to blunt criticism over the issue, asked businesses to submit suggestions to reduce the burden of regulation.
But it’s easy to complain about excessive regulation. It’s harder to find a balance between necessary, effective regulations or inspections and costs.
The examples of a tainted medicine that has killed 23 people and foodborne diseases that kill 3,000 people a year illustrates the need to approach the issue seriously, without hyperbole.