If the COVID-19 pandemic has taught us anything, it’s that the United States Food and Drug Administration is in desperate need of an overhaul. Instead of doing its part to keep Americans healthy, its limited approval processes and overly cautious approach to innovation are putting us all at risk.
Some have argued for years, with mixed success, that the agency’s approval process for new drugs and medical devices is so cumbersome that it increases the costs of bringing 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 costly approval process would reduce the cost of medical innovation, with the savings passed on to consumers, reducing the price of health care without government mandates or the imposition of pharmaceutical price controls.
This is unfortunately the kind of approach that makes too much sense to fly to Washington.
All of this has real-world implications. In 2017, Congress passed the Over-the-Counter Hearing Aids Act, bipartisan legislation drafted by the senses. Chuck Grassley, Republican of Iowa, and Elizabeth Warren, Democrat of Massachusetts. When implemented, hearing aids can be sold in pharmacies and large chains, as it is the consumer’s responsibility to determine their level of hearing loss.
When it takes effect, the price of hearing aids is expected to fall from thousands of dollars to a few hundred – a boon for the country’s estimated 44 million hearing-impaired.
Hearing aids have become smaller, better and less awkward over the past few decades, making it less obvious to use them and allowing people to be less embarrassed to wear them. Technological innovation coupled with reasoned regulation reduces the cost of an essential medical device to participate in the fabric of daily life. Everyone is a winner, right?
Yet the FDA has spent five years working on rules for a deregulated market, as oxymoronic as that may sound, and it’s not done yet. President Biden gave the FDA a much-needed boost soon after taking office, but without a Senate-confirmed Biden appointment to lead the agency in place to move all of this forward, he won’t not much happened.
The delay may be due to a conflict between consumer and business interests. As the over-the-counter rule currently stands, hearing aids could be sold that amplify sounds up to 120 decibels. Comparatively, it’s as loud as a NASCAR race or a jackhammer or a chainsaw, which as almost everyone knows can damage your hearing.
Consumer electronics companies that would make the new devices, like Massachusetts-based Bose, want the rule published as it is now. That’s not a view shared by most of the thousands of people — including a good number of doctors and health care advocates — who have publicly commented on the proposed rule. Like many experts, they said a level of 110 decibels would be safer.
Ms Warren could help get a strong and secure rule by talking about it, but she’s oddly and uncharacteristically quiet about the delay. This has caused some people to wonder if she is the champion of consumers, as she stands, or of businesses.
The provisions of the TBT Act are long overdue. It’s a good policy, but it’s unclear what comments the FDA is hearing. Ease of access and cost savings matter. Security too. It is possible to find a balance between the two without delaying things.