FDA asleep at the wheel

It was an avoidable tragedy. So why did it happen?

To date, 23 people are dead and more than 300 others sickened following an outbreak of a rare form of fungal meningitis, which has affected patients in at least 17 states. The source: tainted steroid injections produced by the New England Compounding Center (NECC) in Framingham, Mass. Americans have reacted with alarm and dismay. But should anyone really be surprised? 

Once again, the Food and Drug Administration (FDA) has been asleep at the wheel. And the results were all too predictable.

To date, the FDA has offered up condolences and explanations, but no accountability. That’s simply not acceptable. The warning signs, and they were everywhere, were ignored by the FDA, as well as by Congress. Sound familiar? Well, unfortunately, we are seeing that same alarming pattern repeated when it comes to prescription drug abuse — now the fastest-growing drug problem in America, according to the Centers for Disease Control and Prevention (CDC).

As a nation, it’s time to get our heads out of the sand when it comes to these very serious public health issues.

For decades, there has been a regulatory distinction between drug compounders, technically known as compounding pharmacies, and drug companies. But as we learned all too tragically in the case of the NECC, this is oftentimes a distinction without a difference.

In theory, drug compounders provide highly specialized, customized medicines that are designed for patients with specific needs. They are supposed to be individualized, made-to-order prescriptions. But in practice, companies like the NECC have been cranking out large quantities of medicines, such as the tainted steroid injections in question, and then mass-distributing them around the country. In this particular case, 17,500 vials of medicine were shipped to 24 states. Individualized? That doesn’t pass the laugh test.

And that’s the rub. While it’s true, as the FDA pleaded in its defense, that compounders are not subject to the agency’s regulatory oversight, there’s also a “yeah, but” to take into consideration. These companies are not subject to FDA regulation so long as they are providing individual prescriptions, not drugs that are being mass-produced.

In reality, the NECC operated like a drug company, but masqueraded as a compounder. The FDA has suspected this for years but refused to take action. The results were predictable and deadly, putting an estimated 15,000 Americans at risk. And today, we still don’t know how many people will die or become sick, because it can take months for a fungal infection to develop.

Here’s what’s so troubling: The FDA raised questions about this same company’s sterile practices years ago. There was an on-site inspection and an FDA warning letter sent, but the NECC claimed to be in complete compliance. And so that was that. No apparent follow-up. No meaningful investigation. No worries. And then people started dying all across America.

In its defense, the FDA has long contended that each individual state is primarily responsible for overseeing compounding pharmacies. But guess what? Just this year, the agency also claimed to have broad authority to prevent the mass distribution of drugs made by compounders. So which is it? And if the FDA has such authority, then why didn’t the agency exercise it to shut down the NECC, which clearly had gone rogue? 

Last week, the House Energy and Commerce Committee, on which I serve as chairwoman of the subcommittee on Commerce, Manufacturing and Trade, has launched a far-reaching investigation into this deadly but avoidable tragedy. It demands our immediate attention. Remember, we’re not talking about botched treatments for a cold or the flu. Fungal meningitis is a very scary health condition, infecting the membranes that protect the brain and spinal cord. It can lead to a painful death.

Unfortunately, history has repeated itself. In 2002, five people became ill and one person died following a similar scare involving the Urgent Care Pharmacy in Spartanburg, S.C., which sold contaminated, bulk-produced injectable drugs. So the FDA has long known — but also long ignored — the dangerous practice of mass-produced compounded drugs.

Legitimate compounding pharmacies do fill an important void in our healthcare system by providing custom-made, individual prescriptions for people who have specialized needs. But it’s time to distinguish the legitimate compounders from companies like the NECC, which are nothing more than wolves dressed up in sheep clothing. These companies, with their arrogant, throw-caution-to-the-wind attitudes, should be treated the same as a drug manufacturer or shut down.

The FDA serves a critically important mission, and it has thousands of hard-working, dedicated employees. But it’s time for the agency to step up its efforts to better protect the American public. Whether it’s going after rogue companies or leading efforts to prevent the spread of prescription drug abuse, FDA officials need to look in the mirror and ask themselves a question. What’s more important: investigating a tragedy or preventing it? So far, we’re only getting bulk-produced answers.

Bono Mack serves as chairman of the House subcommittee on Commerce, Manufacturing and Trade.