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Wednesday, June 28, 2017

ANALYSIS/OPINION:

Beware of legislation authored by Sen. Elizabeth Warren.

Ms. Warren is the Massachusetts Democrat who recently told Yahoo News, “Right now, we do not have too much regulation” — a view that must be shared by approximately 0.001 percent of business owners in America. Her observation was specifically directed toward the banking sector, but Ms. Warren’s regulatory zeal knows no limits.


Consider, as an important case study, her drive to regulate personal hearing aids, known as PSAPs (personal sound amplification products). Her legislative vehicle is the Federal Drug Administration reauthorization bill, which needs to pass in the next couple months. The bill would impose new FDA regulations on existing PSAPs, preempting state laws and regulations that have been on the books for decades.


AUDIO: Matt Mackowiak with best-selling author Mark Bowden


On the surface, it may be understandable for a Republican to consider such a bill. But this is Elizabeth Warren, a woman with scant experience with the private sector, whom we are talking about.

After studying the bill’s language and implications, an army of conservative organizations, from Gun Owners of America to tea party groups, has mobilized to fight this legislation.

A letter in opposition to the bill, signed by more than 20 conservative groups, included this line: “Senator Elizabeth Warren’s proposed legislation … is just another big government ploy to create more regulations and aid corporate rent-seekers while harming consumers by limiting their choices and driving prices higher.”

There are many solid, substantive arguments against it.

First, this bill puts new federal regulations on a previously existing product, which always drives up cost.

Second, this bill would allow consumers to purchase and insert hearing aids without ever seeing a doctor, which minimizes the seriousness of hearing loss and the risk of citizens treating themselves, without first ascertaining the cause. Without seeing a doctor, a patient needlessly forgoes a prescription and medical guidance. Should this bill pass, doctors would be removed from the equation and patients will be left uninformed, undertreated and at real risk of making terrible medical mistakes.

This is no minor concern. Rep. David McKinley testified at a House subcommittee hearing about his own experience with hearing loss and self-diagnosis. The West Virginia Republican recalled that he tried to treat himself, without meeting with an audiologist, a mistake that cost him his hearing in one ear. A specialist later told him that medicine would have solved his initial problem, and that he made it worse by misapplying a PSAP on his own.

Third, states have regulated hearing aids for decades, and there is simply no need for the FDA to step in and treat them as over-the-counter medical devices. Today states make their own decisions about hearing aid coverage, and patients receive advice from trained medical professionals about the cause and severity of their hearing loss, along with guidance about the appropriate steps to correct it. There is no problem that needs to be solved. On 10th Amendment grounds alone, conservatives should oppose this bill.

PSAPs are already available to consumers over the counter and currently they are not subject to strict FDA regulation. The reason? They are not considered medical devices. Fundamentally, this fight is about being able to market PSAPs as “medical devices,” while increasing regulation and government power.

House Energy and Commerce Committee Chairman Greg Walden, Oregon Republican, has said he wants FDA reauthorization to pass swiftly, without distracting amendments. His best option is to not include Ms. Warren’s amendment, as dozens of groups will be mobilized against this controversial language, jeopardizing the FDA reauthorization bill’s passage.

A compromise may be suitable to all sides, where the bill removes “moderate” hearing loss for such over-the-counter PSAPs. Removing the more serious category of moderate hearing loss, and leaving it to apply in “mild” hearing loss cases would better serve the purpose of the bill’s authors.

But again, on general principles, conservative Republicans should be wary of any regulatory legislation that Ms. Warren is championing, especially one that makes the worthwhile goal of FDA reauthorization more complicated than it needs to be.

Why pick a fight when it’s unnecessary?

Matt Mackowiak is the president of Austin, TX and Washington, DC-based Potomac Strategy Group, a Republican consultant, a Bush administration and Bush-Cheney re-election campaign veteran, and former press secretary to two U.S. senators. He is the host of a new national politics podcast, “Mack on Politics,” produced in partnership with The Washington Times. His podcast may be found at washingtontimes.com/mackonpolitics.


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