Stronger FDA oversight might have prevented the fungal meningitis outbreak… (CJ Gunther / European Pressphoto…)
So far, 31 people have died of fungal meningitis and nearly 400 more have been sickened by contaminated steroid shots made by the New England Compounding Center in Framingham, Mass. Could these deaths and illnesses have been avoided?
It’s a distinct possibility, argues Boston University law professor Kevin Outterson in a commentary published online this week by the New England Journal of Medicine.
Outterson, who specializes in healthcare law and pharmaceutical markets, says that a 1997 law would have given the U.S. Food and Drug Administration more authority to regulate compounding pharmacies – except that some of its provisions were overturned by the Supreme Court in 2002.
“It’s possible that if the Supreme Court hadn’t struck down [the law], the tragedy at NECC could have been averted,” Outterson wrote.
The case was called Thompson vs. Western States Medical. At issue was whether Congress could forbid compounding pharmacies from advertising the drugs they sold.
The ban was put in place because these pharmacies are supposed to fill prescriptions only for drugs that aren’t readily available – producing low-dose pills, for example, or a liquid form of a medicine that is normally sold in a capsule. Under these circumstances, “advertising was unnecessary,” Outterson explained.
But seven pharmacies challenged the 1997 law – an amendment to the Food, Drug and Cosmetic Act known as Section 503A – as an unconstitutional restriction of free speech. In a 5-4 vote, the justices agreed. The other provisions of the law wound up in regulatory limbo.
The FDA did issue a policy guide asserting its authority to require the compounding pharmacies to follow certain rules. Among them:
* The pharmacies could not make significant quantities of drugs before having prescriptions for them in hand.
* The pharmacies could not use manufacturing or testing equipment designed for large commercial operations.
* The pharmacies must follow the laws and regulations of the states where they operate.
NECC appears to have violated all three of these conditions with its production of preservative-free methylprednisolone acetate, Outterson wrote.
The FDA is not well-equipped to protect consumers from unscrupulous – or merely sloppy – compounding pharmacies, he said. There are thousands of compounding pharmacies in the U.S., but they don’t have to submit any records to the FDA; in fact, they don’t even have to tell the FDA that they’re in business. If inspectors want to visit a manufacturing facility, pharmacies can go to court to keep them out for months at a time.
“If Section 503A had not been struck down, both the FDA and Massachusetts would have been more directly involved in regulating NECC for more than a decade,” Outterson wrote.
New legislation is needed to give regulators a fighting chance to protect public health, according to an editorial published along with Outterson’s commentary. The journal threw its support behind a new bill sponsored by Democratic Congressman Edward J. Markey of Massachusetts. If passed, the Verifying Authority and Legality in Drug (VALID) Compounding Act would make pharmacies like NECC that “operate as drug manufacturers” accountable to FDA regulations, according to the editorial.
“Regulators need a strong mandate to protect the public health,” the editorial says. “Too many patients have suffered and died as a result of compounding errors, which should be made a thing of the past.”
In a final note, Outterson noted that there isn’t good medical evidence that injections of steroids like the one made by NECC really work to relieve back and joint pain. A 1991 study in the New England Journal of Medicine concluded the treatment is “of little value,” and a 2009 analysis in the journal Spine found that “there is insufficient evidence to support the use of injection therapy in subacute and chronic low-back pain.”
Regarding the current outbreak, Outterson wrote: “These problems cannot be laid entirely at the feet of compounders when clinicians persist in clinical practices despite weak evidence of efficacy.”
You can read the commentary online here, and the editorial here.
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