- The Washington Times - Tuesday, February 15, 2022

If the COVID-19 pandemic taught us anything, it’s that the U.S. Food and Drug Administration is in desperate need of reorganization. Instead of doing its part to keep Americans healthy, its hide-bound approval processes and overly cautious approach to innovation put us all at risk.

Some have argued for years, with mixed success, that the agency’s process for approving new medications and medical devices is so cumbersome it elevates the costs of getting new therapies to market. And that helps make them too expensive for some people to use once they become available. A streamlined and, therefore, less expensive approval process would reduce the cost of medical innovation, with savings passed to the consumers reducing the price of health care without government mandates or the imposition of pharmaceutical price controls.

That, sadly, is the kind of approach that makes too much sense for it to fly in Washington.

All this has real-world implications. In 2017 Congress passed the Over-the-Counter Hearing Aid Act, bipartisan legislation written by Sens. Chuck Grassley, Iowa Republican, and Elizabeth Warren, Massachusetts Democrat. When implemented, hearing aids can be sold in drug stores and big-box chains because the onus shifts to consumers to determine their level of hearing loss.

When it goes into effect, the price of hearing aids is expected to drop from the thousands of dollars to a few hundred — a boon for the nation’s roughly 44 million hearing-impaired people.

Hearing aids have gotten smaller, better and less obtrusive over the last few decades, making it less obvious that they are in use and letting people be less self-conscious about wearing them. Technological innovation coupled with sensible regulation reduces the cost of a medical device essential for participating in the warp and woof of everyday life. Everyone’s a winner, right?

Yet the FDA has spent five years working on the rules for a deregulated market, as oxymoronic as that sounds, and is not done yet. President Biden gave the FDA a much-needed nudge shortly after coming into office but, without a Senate-confirmed Biden appointee to lead the agency in place to push it all through, not much has happened.

The delay is perhaps due to a conflict between consumer and corporate interests. As the over-the-counter rule currently stands, hearing aids could be sold that amplified sounds of up to 120 decibels. Comparatively, that is as loud as a NASCAR race or a jackhammer or a chainsaw, which, as most everyone knows, can damage your hearing.

The consumer electronics companies that would manufacture the new devices, like Massachusetts-based Bose, want the rule to be issued as it now stands. That’s not a view shared by most of the thousands of people — including a fair number of doctors and health care advocates — who offered public comment on the proposed rule. They, like many experts, said a level of 110 decibels would be safer.

Ms. Warren could help get a sound and safe rule out the door by talking about it, yet she is oddly and uncharacteristically silent about the delay. That’s left some people wondering if she’s the champion of consumers, as she portrays herself, or corporations.

The provisions of the OTC Act should have been implemented long ago. It’s a sound policy, but it’s not clear which comments the FDA is hearing. Ease of access and lower costs matter. So does safety. It is possible to strike a balance between the two without holding things up.

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