OUR VIEW
It’s a funny thing about regulations: If it is not mandatory that anyone follow them, then they really aren’t regulations.
We have to wonder whether Congress fully understands this. Consider the recent passage of legislation intended to address future problems like last year’s deadly outbreak of fungal meningitis caused by contaminated steroidal medication.
In the heat of public scrutiny, authorities felt compelled to take action after New England Compounding Center (NECC) distributed the medication to health providers throughout the country, leading to 64 deaths and more than 750 people made ill after taking the medication. In Tennessee, 16 people died and 153 were sickened.
But what did lawmakers actually do for public safety? Essentially nothing.
The bill is intended to bridge the gaps between U.S. Food and Drug Administration oversight and that of state pharmacy boards when large compounding companies sell and distribute in other states.
U.S. Sen. Lamar Alexander wrote recently in this newspaper in support of the bill, which was sent to President Obama to sign last week. “Once this bill is signed into law, there will be no confusion over who is in charge of overseeing a particular facility that makes sterile drugs,” the Tennessee Republican said.
But there is a problem: The bill makes it optional for companies like NECC to register with the FDA as an “outsourcing facility,” which would subject them to inspections and quality control before they ship. Under the bill, a company could decline to register, engage in unsafe practices and face no consequences until the tainted drugs reach the health provider — or worse, are injected in patients.
Yes, an unregistered company still falls under the oversight of the pharmacy in their home state. But so did NECC. It didn’t help.
The International Academy of Compounding Pharmacists and patient advocates have complained of this toothless legislation, but most of the attention has been on the fact that any bill could pass both houses of our ineffectual Congress.
Perhaps it passed because it’s merely a placebo, meant to make the public believe something has been done to safeguard its health, but with no political consequences.
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