IT’S PAINFUL ENOUGH when a disease like West Nile virus sweeps the country, as it did this summer, causing 168 deaths. But the current fungal meningitis outbreak is noteworthy for something else. It marks a lapse in the responsibility of government to protect against such a disaster. As of Tuesday, 15 people have died and 233 have been sickened by a contaminant in steroid injections for back pain, shipped to clinics in 23 states by the New England Compounding Center of Framingham, Mass. Other medications also may have been tainted.
In general, compounding pharmacies mix or alter ingredients to make custom medications to fit the needs of an individual patient. But since the early 1990s, some compounding pharmacies have expanded dramatically, shipping bulk medicines to hospitals and clinics without individual prescriptions. In effect, they became the equivalent of small drug-manufacturing companies.
At the federal level, regulation of drug manufacturing is carried out by the Food and Drug Administration (FDA), which ensures that medicines are safe and effective. The FDA requires lengthy clinical trials and enforces rigorous manufacturing standards. Congress gave the FDA some oversight power in 1997 over compounding pharmacies, but several of the firms challenged the law in court. At issue was the FDA’s power to regulate their brochures and advertising. In 2002, the Supreme Court ruled for the pharmacies. Two appellate court decisions since then conflict about whether the original law is valid and enforceable. Congress has failed to clarify the situation.
The compounding pharmacies are not required to inform the FDA that they are in business, nor to register with the FDA or to disclose what products they are making. This makes it difficult to inspect them or enforce the rules before something goes wrong. The FDA has moved after problems arise, such as with a tainted product or a mislabeled one. But compounded drugs are not FDA-approved. The agency’s enforcement effort has been more reactive than proactive.
The states are largely responsible for licensing and regulating day-to-day operations of compounding pharmacies. But this oversight also is weak. For example, under Massachusetts rules, the New England Compounding Center should have possessed a prescription for each injection. However, Reuters published e-mails over the weekend that show the firm solicited bulk orders and failed to obtain proof that each dose was backed up by a prescription. The company shipped 17,676 injections, of which more than 13,000 reached patients after May 21.
The federal government, Congress and the states all bear some blame for this lapse of oversight. There are proven methods to prevent contaminated medicine from reaching patients — methods that were simply not used in this case. Congress can remedy the situation by putting the regulation of large-scale drug compounding unequivocally under FDA control. The health and safety of Americans demand that government not fail a second time.