In late June, FDA approved the marketing of a device to treat breathing difficulty in people with severe emphysema. The device, called the Zephyr Endobronchial Valve, closes during inhalation, keeping air from getting into damaged areas of the lung. During exhalation, it opens and lets out air to relieve pressure.
This device has unique features, but there’s not too much unique about FDA clearing a new device for marketing in response to a company’s application. They do stuff like that almost every business day.
And yet, if you think of regulatory agencies as nothing but annoying and unnecessary roadblocks standing in the way of industry plans – I don’t, but some folks who do are holding sway in public policy discussions these days – agency announcements like this one remind you that you’d rather FDA not be involved at all in the process of pre-approving products for marketing.
A revolutionary suggestion? Not really. In fact, new drugs didn’t used to be required to get any clearance before marketing. Then the law was changed to require drugs to be cleared only on the basis of proof to FDA that they were safe. Later, the law was changed again to require proof of effectiveness as well as safety, and that’s the system we have today.
Similarly, medical devices didn’t used to require clearance before marketing. After the requirement was added to the law in 1976, it has been tweaked and altered and amended and altogether made more complex.
Those who think about such things wonder aloud now and then whether all this complex prior approval of devices and drugs really adds protection of public health, and proposals to change or eliminate FDA reviews and approval arise with some regularity.
Interestingly, though there are always some voices advocating this type of radical shift in FDA’s powers, word is that drug companies aren’t among them. They would rather FDA does stay in the approval business. It makes for a fairer market for them because they don’t have to compete with charlatans, and they like the imprimatur of the government’s blessing.
So let’s ask ourselves: What would happen if the law was changed and FDA was put out of the business of approving devices and drugs before they could be marketed. Let’s speculate:
Would companies still conduct clinical trials of their products of the type they now need to support applications for FDA approval to assure they were safe and effective? Probably they would, in part to avoid hurting people or being accused of marketing a worthless product, and in part to persuade doctors that the product was worth using.
And I betcha a private standard-setting organization, perhaps the American Medical Association or ASTM, would suddenly get into the business of reviews and granting their own organization’s approvals of products. And then, I would bet, a big retailer like Walmart would announce that it wouldn’t sell drugs that didn’t have the AMA or ASTM seal of approval, and voila, you have replaced a government bureaucracy with a private one.
Would such a system save money? Probably not, if the same scale of clinicals were still being conducted, but for those who hate having government doing things, this would feel better.
Given the current political climate, in which “regulation” is often a dirty word, don’t be surprised to see proposals to eliminate or limit FDA’s product approval roles get new traction in the coming months and years. If these changes get made, let’s see how many of the predictions above come true.
INFORMATION ONLY. NOT LEGAL ADVICE