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Sharfstein’s FDA replacement: Why not Cleveland Clinic’s Steven Nissen?

12:08 pm by | 0 Comments

Dr. Steven Nissen

He’s a long shot. But Cleveland Clinic cardiologist Dr. Steven Nissen may be exactly what the troubled U.S. Food and Drug Administration needs.

Conventional wisdom is that the departure of FDA Deputy Commissioner Joshua Sharfstein represents an olive branch to newly empowered Congressional Republicans, who viewed Sharfstein as hostile to the industry. Sharfstein sought to crack down on drug and device companies and was once a staffer with a Democratic Congressman. So the safe bet is that Sharfstein’s replacement will be someone who’s viewed as more industry friendly and therefore more palatable to Republicans.

Tapping Nissen, who’s essentially hated by Big Pharma, would signal the exact opposite from President Obama. A Nissen nomination would symbolically show that Obama won’t back down from a fight with Republicans — and perhaps temporarily quiet a liberal base that sees him as at best too willing to cave to the GOP, and at worst, weak, ineffectual and just another opportunistic politician without any strong core beliefs.

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Plus, Nissen’s affiliation with the prestigious Cleveland Clinic, recognized as the nation’s top heart hospital for 16 consecutive years, only adds to his cachet. Obama has praised the Clinic for providing high-quality care for a low cost (and Obama also bench-pressed 260 pounds during a visit to the hospital’s gym).

Sharfstein is leaving the U.S. Food and Drug Administration to head Maryland’s health department. John Taylor, the FDA’s top lawyer, has been appointed as acting deputy commissioner for 60 days, and may very well be eventually chosen for the permanent post.

Nissen declined comment through a Cleveland Clinic spokesman.

It’s not as if talk of Nissen joining the FDA is a new thing. Shortly after Obama’s election, industry insiders speculated that Nissen was among the leading candidates for the agency’s top job. “Big Pharma would go to the mat to stop Nissen, but he has plenty of cred on Capitol Hill after raising alarms about drugs, including GlaxoSmithKline’s Avandia, J&J’s Natrecor, and Pargluva, a diabetes medicine that Merck and Bristol-Myers Squibb failed to bring to market,” the Wall Street Journal reported at the time.

In particular, Nissen rose to national prominence as an early critic of Vioxx, a painkilling drug that Merck later pulled off the market. He also garnered attention by publishing a 2007 paper that argued that diabetes drug Avandia causes heart attacks. The FDA last year allowed Avandia to remain on the market, but with significant restrictions.

The public stands Nissen took against those drugs show he’s not afraid of a fight when he believes he’s right — something Obama’s critics on the left may not say about the president.

There’s at least one thing for Republicans to like about Nissen — like many GOPers, he’s been a harsh critic of the FDA. “I think the FDA has lost its way in terms of its mission,” he told the Plain Dealer two years ago. “It is truly a failed agency. We have to change the culture.”

And Nissen has been specific about some of the changes he’d like to see at FDA. He supports a fixed six-year term for the agency’s chief as a means of insulating the FDA from political pressure. He’d also like to see a change to the FDA’s funding mechanism. The FDA generates much of its budget through user fees imposed on drug companies that some critics believe give the industry too much influence.

And then there are the suggestions that really tick off Big Pharma. First, Nissen would  like to see more transparency from the agency on its decision to approve or not approve drugs. He’s called on the FDA to publish the letters it sends to drugmakers that detail why a drug has or hasn’t been approved, as well as data from drugmakers’ clinical trials.  Additionally, he supports giving the FDA the power to restrict direct-to-consumer advertising of drugs during their first two years on the market — a position that quite possibly may have resulted in his photo being placed on a few dartboards in Big Pharma boardrooms.

Alas, sadly for drug-industry critics, a Nissen nomination is likely not be. Taylor is already receiving support to be appointed Sharfstein’s permanent replacement, and with Taylor already holding down the spot on an interim basis, he appears the most logical and likely choice. And it certainly doesn’t hurt his case with Republicans that Taylor has worked in regulatory positions under both Bush administrations.

But if the Republicans are spoiling for a fight about the FDA, Obama shouldn’t balk from giving them one. Nissen has shown he isn’t afraid of a fight — and knows how to win them.

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Brandon Glenn

By Brandon Glenn MedCity News

Brandon Glenn is the Ohio bureau chief for MedCity News.
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