martes, 26 de febrero de 2019

The definitive guide to today's drug pricing showdown in the Senate




Nicholas Florko

What’s in store for today? 


Your loyal scribe spent his Monday afternoon chasing senators through the Capitol for the latest intel on how they plan to make drug makers squirm at today’s hearing.
Here are my five takeaways:
  1. Both Republicans and Democrats want to know why the U.S. pays more for drugs than other nations — and that question is likely to loom large. Members across the ideological spectrum — everyone from Democratic Sens. Sheldon Whitehouse and Ben Cardin to conservatives like Sens. James Langford and Bill Cassidy brought up the issue in conversations Monday. Exactly how Congress can tackle this issue is still unclear, but something tells me many Democrats aren’t eager to support the Trump Administration’s plan of tying what Medicare pays for drugs to what other countries pay.
     
  2. Chairman Chuck Grassley wants an answer to a simple but contentious question. I caught up with Grassley Monday to ask him what he plans to ask drug makers. His response was to the point: “How do you set prices?” While the teams of attorneys preparing the CEOs undoubtedly have crafted an answer to the question, drug makers have long fought any and all measures to require more explanation of how they set their prices. They’ve even gone to court to fight state laws requiring such disclosures. Grassley’s long been a fan of price transparency, and if he decides to pick a fight (like by using his subpoena power to get more intel), it could set off a huge political battle. (Remember, staff for Grassley and Wyden spent 18 months pouring over documents from Gilead over how the company set its price for the Hepatitis C drug Sovaldi.)
     
  3. There’s an increased interest from Republicans in particular on patent and exclusivity issues. Cassidy is expected to ask questions about so-called evergreening and how rebates are used to thwart competition for lower cost drugs — commonly known in wonky circles as the “rebate trap.” But Cassidy isn’t likely to be the only one to bring up the issue, one lobbyist following patent issues told STAT Monday.
     
  4. Democrats want to know why drug makers haven't used savings from the Republican tax bill to lower prices. Sen. Bob Menendez (D-N.J.), mentioned this hot topic to me Monday. It’s a well-worn refrain from Democrats that drug makers should have used their tax savings to lower prices, but it’ll be interesting to see how drug makers actually respond when pressed on the issue.
     
  5. Lawmakers are not going to stand for drug makers trying to shift blame to others in the supply chain.Grassley sent a shot across the bow Monday afternoon, tweeting that drug makers shouldn’t “try to blame everyone but themselves/take no responsibility for their role in fixing the problem.” Ranking member Ron Wyden (R-Ore.) towed a similar line in a brief interview with STAT. “The main thing I’m interested in getting tomorrow is whether they’re gonna step up and get beyond the blame game,” Wyden told STAT on Monday.
If that didn’t convince you to tune in later this morning, maybe Sen. Tom Carper of Delaware will.  “You could sell tickets for this one,” Sen. Tom Carper (D-Del.) told STAT. “I’d pay.”

STAT Scooplet: Consumer groups are spending big on ads


Several anti-pharma coalitions are using the publicity around today’s hearing to drive home their push for action to lower drug prices. Chief among them: the patent reform group CAPA, which is paying to wrap today’s Washington Post in a two-page ad.

The group’s message: “Patent Abuse is Standard Practice for Big Pharma.” The ad targets six drugs in particular: Abbvie’s Humira, Bristol-Myers Squibb’s Eliquis, J&J’s Remicade and it’s blood thinner Xarelto, Pfizer’s Lyrica and Sanofi’s Lantus. (As a reminder, CAPA, which launched last month and boasts members including the Association for Accessible Medicines, America’s Health Insurance Plans and Kaiser Permanente, is pushing to make patent reform a larger part of the discussion on high drug prices.)

CAPA isn’t the only one spending big today. The Coalition for Sustainable Rx Pricing is spending in the high five figures to run an ad on CNN and Fox News today. The ad, a mock advertisement for the drug “PriceGougi$ol,” whacks drug makers for spending more on advertising than research and development.

What it’s like to prepare for one of these hearings


My colleague Lev Facher and I spent this past weekend getting a crash course on what it’s like to prepare for a congressional oversight inquiry. (My guess is that the seven execs coming before the committee later today did, too.)

Here’s what we learned: There’s an entire cottage industry of law firms, lobby shops, and PR outfits staffed by former lawmakers and congressional aides, all of which specialize in making sure execs don’t put their foot in their mouth when they’re talking to lawmakers.

The story, which is chock full of details from more than a dozen former lawmakers, staffers and lobbyists, is worth your time. But I can’t help sharing my favorite detail here: the “murder boards,” where CEOs are forced to sit through hours-long mock hearings so they can practice reciting their canned answers and keeping their cool, all while the consultants they’re paying try to bait them and berate them the way lawmakers might.

Read more.

And if you’re wondering who spent the weekend getting "murder boarded":


My colleague Damian Garde and I have the go-to guide on the seven execs testifying. I promise, these aren’t details you’re going to get just by reading their bios online — we dug into everything from one CEO’s tumultuous experience testifying before British Parliament to how investor types are banking on another CEO to keep things on the rails.

If you’re looking for one figure to focus on today, here’s my pitch for why you should be watching Pfizer’s newly minted CEO Albert Bourla.

First, he’s only been CEO of Pfizer for a month, so it’ll be interesting to see his first real foray into the drug pricing debate. Second, he’s taking over for Ian Read, the former CEO who famously sparred with Trump over drug pricing (Which raises an obvious question: will we see more of that?) Third, if past is prologue, lawmakers will have tough questions for Pfizer. And fourth, Pfizer is often seen as something of a bellwether for other companies in the sector.  They’re “the largest one of the bunch and typically they are looked to as a sort of signal for the industry,” one drug industry lobbyist explained to STAT.
 
Read more.


And in case that wasn’t enough wasn’t CEO talk for you, I spoke with NPR’s Weekend Edition about this topic as well. You can listen to that here.

A look at FDA user fees’ lackluster impact on drug prices


New research from the Pew Charitable Trusts asks and answers an important, albeit wonky, drug pricing question: What impact has FDA’s generic user fee program had on drug prices? And the answer is a bit sobering...

As a refresher, Congress created the generic drug user fee program in 2012 to help FDA get generic drugs onto the market more quickly, with the ultimate goal of eventually driving down the price of those drugs. Pew found that during the first five years of the user fee program, FDA approved nearly 17 percent more generics (which is good!) but here’s the catch: The majority of the drugs approved were the fourth, fifth and sixth copies of a brand drug to hit the market, which have minimal impact on the price of the drug they copy. (The most impact is from the second and third generics that hit the market.)
 
Despite the creation of the generic user fee program, FDA has had a much harder time getting the first few generics for a drug into market — more than 500 drugs still lack any generic competition, according to FDA data.

Worth your time


Health insurers give six-figure payouts to brokers who are supposed to help employers get a good deal on insurance plans for their employees. But the convoluted system drives up costs for patients. ProPublicauntangles the web. — Ike Swetlitz

Dr. Richard Sackler, the enigmatic former president of Purdue Pharma, was "well aware" of many physicians' false view that the pain drug OxyContin was weaker than morphine. Yet according to transcripts published last week in STAT and ProPublica, the company made no effort to accurately market the drug.  — Lev Facher

It's not strictly a Washington story, but it's hard not to be fascinated by the super-secretive health company Atul Gawande is helming for Amazon, J.P. Morgan Chase and Berkshire Hathaway. STAT's been all over a Massachusetts lawsuit that's unveiled a lot of new details about what the company is up to. — Erin Mershon 

A hat tip to KHN for this look at the potential parallels between today's hearing and hearings held sixty years ago on the same topic. — Nicholas Florko

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