Unlike every other country in the world at the time, the U.S. founded its judicial system on the premise “innocent until proven guilty.” Under that guiding principle, the burden of proof – in any enforcement action – lies with the…
Author Archives: Mari Serebrov
The FDA: Stuck in 1984
January 23, 2012 – 12:38 pm
While 2012 has dawned everywhere else in the world, it’s still 1984 at the FDA. With its Bad Ad program, whistle-blower suits and spotters of conference crimespeak serving as its globalwise eyes and ears, the agency has adopted Big Brother…
It’s About the Patient
December 13, 2011 – 8:11 pm
An FDA advisory committee this week gave a half-hearted vote of approval – 9-8, with two abstentions – for Alexza Pharmaceuticals Inc.’s Adasuve (Staccato loxapine). But the vote was conditioned on limiting the inhaled antipsychotic to one dose per day…
Drug Shortages? We Ain’t Seen Nothin’ Yet
October 6, 2011 – 11:18 am
You think the drug shortage is a devil now translation
A Little Bit of Certainty Could Go a Long Way
September 23, 2011 – 11:19 am
Regulatory certainty. It’s something industry needs and investors want to see. It’s also one of the drivers for job creation. But it’s something our government doesn’t seem to get. translation
Unless it’s Affordable, Curing Cancer is Just a Dream
August 30, 2011 – 12:43 pm
Although they’re the stuff of science, statistics too often lack the power to move us. After all, they’re just numbers. So when companies like Dendreon Corp. and Seattle Genetics Inc. price their cancer treatments at nearly $100,000 or more, we…
It’s Time for Biopharma to Speak Up
August 24, 2011 – 11:14 am
Free speech. Most of us take it for granted. Unless you’re a drug company, that is. Since the FDA doesn’t trust biopharma when it comes to drug promotion, the agency believes that, as the watchdog of public health, it’s justified…
Don’t Price Drugs on What the Market Used to Bear
August 9, 2011 – 9:52 am
All those warnings about price pressures and reimbursement woes – they didn’t come from Chicken Little. The sky really could be falling for drugmakers that insist on pricing their products based on what the market used to bear. translation
Putting Overseas Earnings to Work
July 13, 2011 – 3:07 pm
It doesn’t take a PhD in economics to come up with practical solutions to jumpstart our economy and create jobs. But it does take guts – and real-world vision – to implement change that makes a difference. translation
Confessions of a BIO Newbie
June 27, 2011 – 1:27 pm
I confess. When it comes to the BIO International Convention, I’m a newbie. So please forgive me for thinking it was just another conference. translation
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