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 By now, millions of Americans have heard the good news that hearing aids will
soon be available over the counter and will likely hit the shelves by the end of
2022. The newly finalized rule by the Food and Drug Administration (FDA) gives
patients the option of bypassing costly exams at the doctor’s office.
While the rise of over-the-counter hearing aids should be celebrated by consumer
and patient advocates, this rule change is just the beginning of the fight for
patient-centered care. Federal agencies are determined to force patients to
spend hours in the waiting room to access crucial technologies that could save
or improve their lives. It’s time for lawmakers and bureaucrats to put consumers
first and lower health-care barriers.
Hearing aids are not the only game-changing health-care product stymied by
federal gatekeeping rules. According to a 2020 report by the Cato Institute,
“the FDA requires consumers to obtain prescriptions before purchasing naloxone,
a safe, effective drug that reverses opioid overdoses. The drug reverses
depressed respiratory rate and blood pressure by knocking opioids off the
recipient’s opioid receptors and binding itself to those receptors.” Even though
the medication has been on the market for decades and poses negligible risks to
individuals not suffering an opioid overdose, the agency still sees it necessary
to require a doctor’s signoff.
States have designed workarounds and “standing orders” to ease non-prescription
access, but even these fixes come with costly reporting requirements for
pharmacies. In addition, community organizations often find themselves in a
legal gray area when it comes to quickly dispensing the life-saving medication
to patients suffering overdose. Similar to hearing aids, it is easy for
liberalization opponents to point to worst-case scenarios in which patients
don’t properly use these products or get confused. But, requiring doctor’s
visits for everything under the sun is not the answer. Patients can wait a month
or longer just to see a family medicine doctor and may need to shell out
hundreds of dollars if their insurance is skimpy/nonexistent.
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The FDA is beginning to acknowledge this new reality in the realm of at-home
testing. Thanks to a slew of medical innovations, patients can take tests for
everything from COVID to allergies to cholesterol ... without seeing their
doctor first. New types of blood tests can extend this progress to cancer
detection for malignancies that often go undetected and typically require
invasive exams. Patients cannot get their hands on multi-cancer early detection
blood tests without first getting a sign-off from their doctor. And, even if
they were able to, these tests may soon become more expensive and less available
thanks to the actions of the Federal Trade Commission (FTC).
The agency has made clear that it will fight test sequencing companies’ attempts
to acquire test developers, even if integrating the two services would lead to
significant efficiencies for consumers down the road. This fight has already
spilled over into federal court, costing innovators time and money that could’ve
been spent screening patients and designing even better tests. While the FTC is
concerned about industry concentration, the most practical barriers to patient
access come from the gatekeeping imposed by other agencies such as the FDA.
Instead of burying developers in legal fees and onerous rules, federal officials
should work together to expedite access to patients. This would mean allowing
investment dollars to flow into the health-care sector while keeping
prescription requirements at a minimum. Allowing over-the-counter sales of
hearing aids is just the first step in a revolution that will empower patients
and change lives.
David Williams is the president of the Taxpayers Protection
Alliance.
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