FDA outrages critics over sneaky rule change on drugs, medical devices

It’s a short paragraph, fine-print tucked in a 10,000-word document on tobacco product regulations. But these 245 words (see Intended Use Regulations, ง 201.128) have lit up critics of the U.S. Food and Drug Administration. They say officials are trying to pull a fast one, seeking to relax labeling rules for drugs and medical devices. This could make it tougher to hold manufacturers accountable for their products’ harms. The proposed FDA rule change, critics say, relieves companies from providing “adequate labeling” for non-FDA-approved uses of their products that they know about. This applies to detailed explanations inserted with drugs or devices.

Although the change might give companies greater “free speech” in discussing their products and allow for more “off-label” uses, which doctors like, critics decry this alteration. They say the agency needs to get tougher on off-label uses and to force companies to be more rather than less transparent about them

I’ve written, for example, about the abominable practice by some physicians who write prescriptions for powerful anti-psychotic medications for tots; the drugs never have been tested in children. No one will defend this use, though it is increasing and may be a dangerous use of drugs to restrain difficult infants and toddlers. Medical device manufacturers have come under fire when their products were used off-label for unintended uses, resulting in one case in thousands of claims of patient harms.

I’ve written recently how, while most of the world was distracted by year-end holidays, FDA officials were allowing advocates from the industries the agency is supposed to regulate to rewrite key rules. A Senate investigation also just slapped the agency hard for its too cozy relationships with medical device manufacturers, laissez-faire oversight that lawmakers blamed for contributing to a device-linked infectious outbreak that sickened and killed dozens at hospitals across the country. The Senate panel also ripped hospitals and the device maker for their ineffectual responses.

If I read the FDA answer to the Minneapolis Star-Tribune, which deserves credit for dogging the proposed rule change, the agency is saying something  lame: We’re not enforcing this part of the law, so let’s get rid of it; we have other powers that could keep in check any issues. That’s an odious admission. An agency failing to enforce its own regs?

When a Senate panel led by Sen. Patty Murray (D.,-Wash), examined FDA oversight in the recent, deadly medical device case, the agency eventually held its palms in the air and shrugged. It said that to fix the multiple reporting and regulatory issues that patients got sick and died over, well, that would take a while and cost a lot of money. Fortunately, Murray seems undeterred. Among the proposals she and others are considering, ironically, call, for example, for more labeling on medical devices. Investigators say it may be time for each device to bear a unique number, a bar code that would be recorded when it is used in a procedure. This would allow experts, for example, to track faster and attack better problems when devices make patients sick or cause them to die. Prescription drugs carry such bar codes; not all medical devices do so.

With the big money and the burgeoning business in drugs and medical devices, the FDA, candidly, has tough responsibilities to carry out. But it’s distressing to see that it takes lawmakers, journalists, and the civil justice system all too often to put a lash to its bureaucrats to get them not to cut corners, not to go easy, and to fall down on their critical role in protecting Americans’ health and well-being.

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