Author Archives: Mari Serebrov

If no one reads it, what’s the purpose of a drug label?

Robert Califf said it when he was serving as FDA commissioner. Patient advocates have said it when testifying before Congress or commenting at public meetings. And this week, experts on the FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) said it again:…

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Real-world optics of biopharma price hikes

While reducing prescription drug prices won’t fix the overall growth in health care spending in the U.S., bringing those prices down is a top priority for most Americans heading into this year’s midterm elections. There’s a reason for that. Because…

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Drug quality from a patient’s perspective

Dirt. Excrement. Glass. Hair. Insects. Mold. Rodent infestation. Scouring pad fibers. Unknown particulates. They’re words too often mentioned in FDA warning letters that describe manufacturing conditions for supposedly sterile drugs. A few years ago when I was a cancer patient…

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Importation a cliché, not a CAPA

The right hand not knowing what the left hand’s doing. Robbing Peter to pay Paul. Talking out of both sides of the mouth. . . . They’re all clichés that aptly describe how the U.S. Congress too often works. Especially…

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No choice, no free market

Inundated with heart-wrenching stories about constituents who can’t afford the prescription drugs they need to live, U.S. lawmakers spend a lot of time lamenting a free market that isn’t working and then debating ways to “fix” it. Reality check: A…

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Myth busters take on drug prices, or do they?

Hoping to debunk biopharma’s biggest justification for high drug prices, Public Citizen released a report Monday showing that the 20 biggest drug companies collectively generated more than $100 billion in annual profits from 2013 through 2015, nearly double what a…

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Is ‘what the patient pays’ the right barometer for pricing drugs?

Just a few months ago, Mylan NV got caught in a net of its own making when it raised the U.S. list price for a two-pack of its Epipen to $608, a 550 percent increase over several years. The hue…

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Yes, there’s a doctor in the House (and Senate)

It was out with the old and in with the new Tuesday as the 114th U.S. Congress gave way to the 115th. Among the new delegates taking their seats in the House were a few more doctors, a dentist and…

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Left on the garbage heap of the 114th Congress?

Add this to the list of things the 114th U.S. Congress likely won’t get done before it fades into history on Jan. 3: Providing relief from the inter partes review (IPR) intimidation racket. It’s not for want of trying. But…

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Will biosimilar carve-outs put R&D for older MAbs on ice?

Unintended consequences. It’s a term that’s bandied about all too often in Washington these days, as it’s become the PC way for lawmakers and agencies like the FDA to save face when they have to admit, “Oops, we didn’t think…

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