Scott Gottlieb, the Trump administration's FDA commissioner,generally gets a big thumbs-up from the pharmaceuticalindustry. But he may end up making some drugmakersunhappy.

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Related: 'Postmarket safety event' affected nearly one-thirdof FDA-approved drugs

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An ex-FDA official, physician, industry consultant, and biotechinvestor, Gottlieb is seen as industry friendly and was certainlypreferable to some other less experienced and moreextreme candidates the White House floated. But he seemsto have a mandate that includes getting drug prices under control-- a topic he mentioned in his initial remarks to FDA staff onMay 15.

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President Donald Trump, meanwhile, has gone from terrifying thepharma industry with pricing criticism to increasingly conspicuoussilence. A White House budget plan releasedTuesday essentially ignored drug pricing.

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Gottlieb's focus seems to be on bringing prices down byincreasing competition. That's going to help some pharma companies.But competition is only good when you're on the right side ofit.

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The FDA has a limited mandate when it comes to drug prices.Anything it can do would be small potatoes compared to lettingMedicare negotiate drug prices -- which was a Trump policy aim atone point. But the president has clammed up about that proposal andon prices in general.

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Gottlieb's speech mentioned some ways the agency could bolstercompetition and get cheaper drugs to patients. They include beingmore flexible about drug approvals, getting generics to market morequickly and boosting competition for complex drugs. He hasalso previously advocated a quicker path to market for both new andgeneric drugs.

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Related: Pharma lobby ousts 22 drugmakers amid U.S. pricingdebate

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The budget echoes another Gottlieb proposal pharma loves:loosening a prohibition on drugmakers sharing data with insurersbefore drugs are approved. That could help firms get greater marketaccess for new medicines more quickly.

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Such steps would favor companies with a strong portfolio of newmedicines on sale and in the pipeline. They will benefit most froma faster approval process for new medicines and the expanded use ofexisting products. And if pre-approval talks with insurers lead tobetter drug launches, then these firms will reap outsize rewards.

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Related: Trump calls drug pricing 'astronomical' andpromises changes

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Drugmakers that rely too much on older and competition-pronemedicines may be less thrilled with a new-look FDA. They will behurt disproportionately by faster generic approvals, and by anytargeting of the legal and regulatory tactics companies use topreserve drug sales as long as possible.

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That firms with newer and growing drugs tend to win out isnothing new. But Gottlieb's plans would amplify the rewards ofbeing on the right side of that spectrum, while worsening the painof firms with aging assets.

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A subset of companies that might be in extra trouble are thosethat rely on expensive biologic medicines -- complicated drugs madewith living cells rather than via chemical processes. These aresome of the best-selling drugs in the world, but have faced littleor no generic competition in the U.S. Long-lived patents accountfor some of that, but these drugs are also trickier toreplicate.

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The process for getting a so-called biosimilar approved and onthe market is substantially tougher than that for a regulargeneric. And the small number of biosimilars that have made it tomarket are not as easy to substitute for the original product.Gottlieb's speech specifically cited getting biosimilars toconsumers as a priority. If he speeds up the process, then thatwill have a major impact on some blockbuster drugs.

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The biggest loser in this regime may be specialtypharma -- companies selling expensive medicines they don'ttypically develop in-house. These firms often focus on olderand more obscure products. They've also become notorious in recentyears -- thanks to the prominent troubles of companies such asValeant Pharmaceuticals International Inc. -- for raising pricesdramatically. When you've got a small or declining market for amedicine, it's the one way to generate growth.

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Many of these firms have already had a rough couple of years dueto criticism of their pricing practices, crackdowns from privatepayers, and an overall uptick in generic approvals.

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If Gottlieb targets firms that have "inappropriately gamed" thegeneric drug process to preserve sales for their older medicines,then specialty pharma firms are likely to face a particularpinch.

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Trump might just be off the drug pricing warpath temporarilybecause he has a few other things on his mind. But until he comesback, it makes more sense to watch Gottlieb to gauge theadministration's temperature on drug pricing.

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This column does not necessarily reflect the opinion ofBloomberg LP and its owners.

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Copyright 2018 Bloomberg. All rightsreserved. This material may not be published, broadcast, rewritten,or redistributed.

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