Posts tagged - Scott Gottlieb

Had Enough of BigPharma? Here’s More

Scott Gottlieb jumps from top FDA regulator to big bucks with Pfizer

Here we are in the middle of a BigPharma crisis — with people dying of opioid addiction, prices on pharmaceuticals skyrocketing, Congress raking in BigPharma campaign money and one-sixth of the American public taking useless  and dangerous antidepressants — and Scott Gottlieb, who served less than two years as FDA Commissioner and who resigned because he “wanted to spend more time with his family” has, predictably, two months later, passed through the “bigpharma revolving door” and joined Pfizer’s Board of Directors. He’ll now make the really big bucks and help the drugmaker speed new drugs through FDA approvals in the “good old boy” network.

Elizabeth Warren, one of the Democrats running for president, has called for him to resign. How about just making it illegal for the director of a federal regulatory agency to jump ship to a regulated industry or vice-versa? One of the perks of FDA employment, for example, is that drug companies often hire FDA staffers who approve their drugs.

Gottlieb will make a minimum of $335,000 a year if last year’s salaries hold, probably much more for his prize stash of FDA intelligence and inside information. Time to stop this stupidity and corruption! Block the revolving door and vote against anybody who takes big money from BigPharma!

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Drugs Approved Faster, Expect More Safety Issues

Since FDA Commissioner Scott Gottlieb has taken over, drug approvals have accelerated according to Bloomberg News, with 34 news drugs approved so far — double last year’s rate. Gottlieb, appointed by President Trump, has a long history of working for and with the pharmaceutical industry so the pro-industry fast tracking was to be expected. Trump has also pledged to “slash restraints” on new drug development.

Now the only conundrum for investors is whether stocks will rise because of so many new drugs coming on the market, or fall because of increased competition that could lower prices.

Regardless, the net result will be more drugs flooding into the country with less scrutiny, and less testing. Nearly one-third of FDA-approved drugs already had to be revisited after safety-related “incidents.” Psych drugs and those on accelerated approval fared even worse. In addition, 90% of new drugs coming onto the market are no more effective than the old drugs they are to replace. But the race to get a piece of the $1 trillion (with a “t) per year pharmaceutical pie is irresistible.

 

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FDA Steps in to Stop Gaming of Orphan Drug System

The FDA is changing the rules on orphan drugs, according to a story on NPR. Makers of orphan drugs – which are developed for rare diseases that affect less than 200,000 people – get special treatment from the FDA, such as tax credits, waivers of fees and a seven-year monopoly on the drug. But orphan drugs can command huge price tags to consumers, and an investigation is under way after critics said some of the orphans — such as the psychopharmaceutical Abilify — were already licensed for common use by the FDA. New Commissioner Scott Gottlieb also announced other measures to be implemented.

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