Gottlieb Eyes Prices, Not Lives

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I thought the FDA was going to be championing a new generation of life-saving medications, not a flood of generics, Dr. Scott Gottlieb.

Do you remember the fanfare accompanying the passage of the 21st Century Cures Act in December 2016?

For that matter, do you remember when Congress actually passed legislation?

As you'll recall, the FDA was given $500 million over nine years along with the charge to foster discovery and innovation while speeding new medications to market.

Apparently, that's not how commissioner Gottlieb sees his mission now.

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It turns out the real goal is going after Washington's favorite whipping boy — high drug prices.

You might have thought he would have prioritized scourges such as cancer, Alzheimer's, MS, and ALS.

To be fair, getting around to these diseases may still be on the FDA's agenda, but for the moment, Gottlieb has his eye on bringing out even more generic versions of drugs we already have.

Here's what the commissioner wrote in a recent blog: “There are a number of branded medicines that are peptides, where exclusivity has lapsed, but these drugs face little or no competition.”

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He went on to say: “We'll soon release other important policies aimed at spurring competition to complex drugs.” I guess the idea is the more copies we have of a drug, the less likely a single manufacturer will create a scandal with a sudden price hike. Maybe.

I don't have anything against generics. I trust brand names, but I can see the logic of limiting patent protection.

I can also see the FDA needs to ensure generics are as close to the original drug as possible.

But I don't understand why Gottlieb has apparently chosen to make price controls the FDA's new mission, especially at a time when we're making such great progress against many diseases that were once considered untreatable.

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It's like a general leaving the battlefield on the brink of victory to chew out the supply sergeant for spending too much on K-rations.

We all get it. No one likes taking medications in the first place, and we'd just as soon not pay for them, either.

As far as our critics are concerned, medications could be free and they'd still be too expensive. The trouble is that talking about cheap drugs is usually just cheap talk.

President Donald Trump promised to rein in drug prices during his campaign.

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Beyond berating Merck's CEO about “rip-off” prices, however, I'm not sure what he's done.

Congress had a chance last summer, but didn't even consider the issue.

Payers could lower prices whenever they want. Instead, they play formulary games that often increase their members' actual out-of-pocket costs.

I can see why Gottlieb wants to chime in on the pricing controversy. He has every right to — as a doctor. But not when he's speaking as FDA commissioner. It's not his job.

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No commissioner I can remember has extended the agency's purview beyond evaluating therapeutic safety and efficacy.

Let's encourage Gottlieb to shift his attention away from trying to save money and back to saving patient lives.

Reducing prices shouldn't be the FDA's goal.

Let's focus once again on driving new life-saving products to the market as quickly as possible.

Sander Flaum is a principal at Flaum Navigators. 

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