Congress is struggling to deal with the slow-motion collapse of Obamacare and put in place a viable alternative, but there are other bills with potential to impact the health and welfare of millions of Americans moving through Congress. Last week the Senate Committee on Health, Education, Labor & Pensions (HELP) advanced legislation to reauthorize FDA user fee agreements that also contained troubling provisions related to hearing aids, and the House is expected to advance it out of committee this week as well.
While there’s a strong argument to be made that excessive FDA regulations reduce public access to needed medications and drive up cost, allowing the user fee authorization to expire would only exacerbate the matter because they account for sizable portions of the budgets for reviewing applications. Losing that revenue would slow the already glacial agency even further and keep needed drugs and medical devices off the market longer than necessary. That’s why HELP Chairman Lamar Alexander rightly called for only non-controversial provisions to be included in the reauthorization bill.
Nevertheless, Senator Elizabeth Warren’s Over-the-Counter Hearing Aid Act was included despite its divisiveness and opposition from free-market groups. It promises to expand access to hearing aids and reduce costs, but runs the risk of accomplishing neither and instead making things worse.
Perhaps most troubling, the OTC Hearing Aid Act overrides state-level preferences and denies local authorities the right to establish and maintain their own rules. It’s fair to say that many states have set overly restrictive regulations that limit access and keep hearing aids out of financial reach for many, but undermining federalism is no answer. Even if the federal government improved upon those rules in the short-term, they would always have the authority to make them more restrictive later, at which point there would be no recourse. With rule-making conveniently centralized, lobbying efforts in that direction would only intensify, and unlike state-level policies, bad rules adopted at the federal level cannot be circumvented by moving elsewhere.
The Warren bill also includes overly vague grants of regulatory authority to the Health and Human Services Secretary. It calls for regulations providing for the “reasonable assurance of the safety and efficacy” of the OTC hearing aids, while also setting power “output limits.” This may sound nice in theory, but in reality provides a loophole sufficient through which to drive a red tape-loaded truck.
The Trump administration might not want to use the new authority to overstep into the market, but future administrations with a more interventionist mindset will have access to the same statutory authority. Bureaucrats are not medical experts and cannot predict where technology will move next, nor react quickly enough when advances are made. Placing all of our regulatory eggs in a single basket makes it more likely that future innovations will be prevented from emerging.
Market competition is the best regulator, and government should intervene only when absolutely necessary.
Personal sound amplification devices (PSAPs) differ from hearing aids in that they are not considered medical devices, and thus not subject to FDA regulation. Though they have proven effective for some with mild to moderate hearing loss, they are marketed for activities like hunting or bird watching. Nevertheless, in practice they have long provided a relief valve for people with certain kinds of hearing loss unable to pay the high cost of harder to access hearing aids.
The fact that PSAPs are not currently subject to FDA controls means they are only a fraction of the cost of hearing aids. The obvious lesson to take from this is that FDA regulation imposes heavy costs that get passed on to consumers. Yet the Warren bill that is supposed to make hearing aids more accessible increases FDA authority and regulation, and even extends it to the previously thriving PSAP market, rather than taking the opposite and more logical approach.
Rather than pile on new regulatory burdens, Congress would be better served by focusing on ensuring the FDA can process applications in a timely manner. That task would be made much easier by excising the controversial OTC Hearing Aid Act from its FDA reauthorization bill.