Have you heard? War­ren has an­other reg­u­la­tory over­reach idea

The Washington Times Daily - - POLITICS - MATT MACKOWIAK

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.

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-the­counter 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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