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Finally, Drug Pricing Consensus: There's No 'Silver Bullet' For This Werewolf

Executive Summary

All sides have resorted to the mythological phrase throughout the debate, and industry can only hope that the phase of the moon changes soon.

A regular gun with lead bullets won't put down a werewolf; at least that's what legend says. One must pierce the heart of the fearsome, mythological creature with a silver bullet to the heart, as its purification properties can purge the monster of its demonic DNA.

Unfortunately, no silver bullet exists to defeat the unique werewolf of high drug prices. At least that's what a growing chorus of voices in the Rx policy sphere is saying.

Rep. Frank Pallone, D-N.J., is among the frustrated monster hunters, noting that "one thing alone" will be a solution to more affordable drug prices.

Speaking at the Center for American Progress a few moons ago, Pallone – who serves as ranking member of the House Energy and Commerce Committee – laid out a menu of legislative items he would like to see Congress take up.

He first touted the creation of a robust generic marketplace as "a major way to try to deal with drug prices effectively," while noting that the House "addressed generics to some extent in the user fee bill."

The House-passed version of the user fee bill includes several provisions related to generics, including eight-month priority reviews for abbreviated new drug applications (ANDAs) when no more than three approved generics exist or the reference product is on the US FDA's drug shortage list and the establishment of a breakthrough-style review program for generics. (Also see "User Fee Bill Or Drug Pricing Bill? House Members Makes Both Cases" - Pink Sheet, 12 Jul, 2017.)

Pallone also discussed a series of proposals that did not make it into the user fee reauthorization bill, such as legislation that would stop innovators from using Risk Evaluation and Mitigation Strategies to prevent generic sponsors from obtaining samples of the brand product, allow the Centers for Medicare and Medicaid Services (CMS) to negotiate Medicare Part D drug prices directly with pharmaceutical companies and authorize "CMS and participating state Medicaid programs to partner with private sector contractors to negotiate supplemental rebates from drug manufacturers."

The congressman also cautioned Democrats not to treat Medicare drug price negotiations as the silver bullet to solving drug pricing.

Hardly The First To Use The Phrase

Pallone has not been the first in the drug pricing policy circle to vocalize the increasingly used phrase for solutions to kill the one-of-a-kind werewolf.

In a statement on a Democrat-proposed bill called the "Improving Access to Affordable Prescription Drugs Act," Sen. Elizabeth Warren, D-Mass., said that, "There's no silver bullet to lower drug prices, but this bill offers a menu of solutions to tackle the drug pricing problem and help bring down health costs for everyone."

The term has also been used by Republicans. Sen. Bill Cassidy, R-La., used the phrase at the Alliance for Patient Access' biosimilar summit in April.

"There is no silver bullet," Cassidy said. "There are a lot of marginal things you can do in the aggregate that will lower costs. And we are looking for those marginal things."

A Senate Republican staffer used the term in January in noting that no single solution exists to solve the pricing problem and preserve innovation. (Also see "Trump, Congress And The Search For Common Ground On Drug Pricing" - Pink Sheet, 18 Jan, 2017.)

The phrase has additionally picked up steam among industry itself. Biotechnology Innovation Organization CEO wrote in a New York Times letter to the editor in May that, “There is no silver bullet for rising health costs.” Steve Miller, Chief Medical Officer at Express Scripts, said in a December 2016 statement that no silver bullet exists "to solving the problem of high drug prices."

Drug firms, and the health care industry in general, can't be happy about having their products analogized to demonic beasts. Companies can only hope that the phase of the moon changes and the public moves on to other worries – or that Congress is populated by Taylor Lautner fans.

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