Tagged U.S. Congress

Best Reads Of The Week With Brianna Labuskes

Happy Friday! Ending a week in which I’ve been wondering if we all have been dropped into the first act of a supervillain movie since the news that the mysterious brain-injury-caused-by-sound has seemingly spread from Cuba into China.

Here’s some other whodunits — health policy thrillers, right? — for this three-day weekend.

Lawmakers were busy: Ahead of Memorial Day, the Senate sent a bill that would overhaul the VA health system and expand the Choice Program to President Donald Trump. While the legislation sailed through the chambers, critics say it’s too drastic a move toward privatized care, a hot-button topic that’s not going anywhere soon (especially with the Koch brothers’ billions behind it). On the other side of the building, the House approved a “right-to-try” bill (… coincidentally also backed by the Koch brothers … ), reviving the measure that had stuttered over the past few months.

• The New York Times: Senate Sends Major Overhaul of Veterans Health Care to Trump

• The Associated Press: Congress OKs Letting Terminal Patients Try Unapproved Drugs


Consider: $685 billion a year. That’s what it costs taxpayers to make health care affordable for Americans, and the price tag is expected to nearly double in the next decade. So, while some Republicans are refusing to touch a fresh attempt at repeal with a 10-foot pole this close to the midterms, others are trying to reclaim the topic that’s clearly going to be at the top of voters’ minds. High premium increases loom large in the next few months as each side races to control the conversation.

• The Wall Street Journal: New Push to Topple Affordable Care Act Looms 

• Bloomberg: It Costs $685 Billion a Year to Subsidize U.S. Health Insurance

And, for what it’s worth, despite Republicans’ attempts to chip away at the health law, the uninsured rate held pretty steady last year.

• The New York Times: Despite Attacks on Obamacare, the Uninsured Rate Held Steady Last Year


Requiring pharma companies to list their drugs’ prices in ads seems like a simple request. As with most things in the dark and confusing labyrinth that is the drug-cost pipeline, though, it’s a bit more complicated. The proposal, which is part of Trump’s blueprint to lower prices, at first seemed like an idle threat. But HHS Secretary Alex Azar keeps bringing it up. Companies are getting nervous, and are left asking — would the rule even be legal?

• The New York Times: Requiring Prices in Drug Ads: Would It Do Any Good? Is It Even Legal?


Adding work requirements to states’ Medicaid programs may be the hot new trend, but a new report shows that it will cost states and the government tens of millions of dollars. And despite garnering savings in the long-run, that money will come entirely from people losing coverage and access to care. On the flip side of things, red states are getting a serious reality check on just how far they can go with changes to their programs.

• Modern Healthcare: States Face Big Costs, Coverage Losses From Medicaid Work Requirements

• The Hill: Red States Find There’s No Free Pass on Medicaid Changes From Trump


The miscellaneous file is bursting with must-read stories, so it’s lucky there’s an extra day in the weekend to fit them all in: Patients addicted to opioids were promised free rehab but were instead put to work 16 hours a day for no pay at adult care homes changing diapers and dispensing medication; some new mothers in China are being forced to pay their medical bills before they’re allowed to see their babies; depression medication, insulin and birth control are ending up in our rivers and streams from poor wastewater disposal practices; scientists are on tenterhooks as they watch the effectiveness of the new Ebola vaccine play out in real time; and a captivating profile surfaced on a doctor who has been accused of putting his quest to make history ahead of the needs of some patients.

• Reveal: Drug Users Got Exploited. Disabled Patients Got Hurt. One Woman Benefited From It All

• Stat: Pharmaceutical Manufacturing Plants Are Sending Lots of Medicine Into the Water Supply

• The New York Times: Want to See Your Baby? In China, It Can Cost You

• The Washington Post: New Ebola Vaccine Faces Major Test in Congo Outbreak

• ProPublica: A Pioneering Heart Surgeon’s Secret History of Research

And make sure you’re following the L.A. Times’ comprehensive coverage of the controversy at the University of Southern California —

• Los Angeles Times: Students Warned USC About Gynecologist Early in His Career: ‘They Missed an Opportunity to Save a Lot of Other Women’


Have a great holiday weekend, and if you’re planning on soaking up any rays, stick with lotion instead of trying any of those sunscreen pills.

Drugmakers Blamed For Blocking Generics Have Milked Prices And Cost U.S. Billions

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Harvard Medical School instructor Ameet Sarpatwari. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5 percent to 26.3 percent for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

(Story continues below.)

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60 percent more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40 percent per unit in just four years, the Medicare data show, and cost $75,200 per beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.

The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52 percent from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

(Story continues below.)

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.

Co-sponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not stepping into this arena and saying that?”


KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation.

Podcast: KHN’s ‘What The Health?’ Much Ado About Drug Prices

President Donald Trump’s blueprint to reduce drug prices frames almost as many questions as answers, but it does shine light on a vexing and complicated problem. Meanwhile, Vermont passed a law to do something that’s not in the president’s plan: import cheaper prescription drugs from Canada. The state will need federal permission to do that, which is unlikely to be granted.

And Timothy Jost, emeritus professor of law at Washington and Lee University in Virginia, discusses the state of the Affordable Care Act and what might be in the health law’s immediate future.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Joanne Kenen of Politico and Rebecca Adams of CQ Roll Call.

Among the takeaways from this week’s podcast:

  • It is not yet clear how many of the myriad proposals in Trump’s 44-page prescription drug price proposal will be implemented, but the plan does jump-start the discussion across a wide range of drug issues.
  • Although Trump walked back his promise to move Medicare toward negotiating drug prices, his drug proposal would move some drugs administered in physicians’ offices — currently paid under a formula — to be handled by the Part D prescription drug plans, for which insurance companies negotiate prices.
  • The drug price initiative is welcomed by Republican candidates who think it will be a potent defense against Democratic charges that GOP efforts on the Affordable Care Act are driving overall health care spending up.
  • With the increasing reports that in the not-too-distant future one or more justices will retire from the Supreme Court, abortion-rights activists are nervous about how a new court would view the issue and are working hard to avoid a big federal lawsuit that could overturn Roe v Wade.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too.

Julie Rovner: Kaiser Health News’ “For The Babies Of The Opioid Crisis, The Best Care May Be Mom’s Recovery,” by Sarah Jane Tribble

Joanne Kenen: Science Magazine’s “Hoping to Head Off an Epidemic, Congo Turns to Experimental Ebola Vaccine,” by Jon Cohen

Rebecca Adams: Kaiser Health News’ “Under Trump Proposal, Lawful Immigrants Might Be Inclined To Shun Health Benefits,” by Christina Jewett and Melissa Bailey and Paula Andalo

Anna Edney: Vox.com’s “The Blockbuster Fight Over This Obscure Federal Program Explains America’s Drug Prices,” by Dylan Scott

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Podcast: KHN’s ‘What The Health?’ Much Ado About Drug Prices

President Donald Trump’s blueprint to reduce drug prices frames almost as many questions as answers, but it does shine light on a vexing and complicated problem. Meanwhile, Vermont passed a law to do something that’s not in the president’s plan: import cheaper prescription drugs from Canada. The state will need federal permission to do that, which is unlikely to be granted.

And Timothy Jost, emeritus professor of law at Washington and Lee University in Virginia, discusses the state of the Affordable Care Act and what might be in the health law’s immediate future.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Joanne Kenen of Politico and Rebecca Adams of CQ Roll Call.

Among the takeaways from this week’s podcast:

  • It is not yet clear how many of the myriad proposals in Trump’s 44-page prescription drug price proposal will be implemented, but the plan does jump-start the discussion across a wide range of drug issues.
  • Although Trump walked back his promise to move Medicare toward negotiating drug prices, his drug proposal would move some drugs administered in physicians’ offices — currently paid under a formula — to be handled by the Part D prescription drug plans, for which insurance companies negotiate prices.
  • The drug price initiative is welcomed by Republican candidates who think it will be a potent defense against Democratic charges that GOP efforts on the Affordable Care Act are driving overall health care spending up.
  • With the increasing reports that in the not-too-distant future one or more justices will retire from the Supreme Court, abortion-rights activists are nervous about how a new court would view the issue and are working hard to avoid a big federal lawsuit that could overturn Roe v Wade.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too.

Julie Rovner: Kaiser Health News’ “For The Babies Of The Opioid Crisis, The Best Care May Be Mom’s Recovery,” by Sarah Jane Tribble

Joanne Kenen: Science Magazine’s “Hoping to Head Off an Epidemic, Congo Turns to Experimental Ebola Vaccine,” by Jon Cohen

Rebecca Adams: Kaiser Health News’ “Under Trump Proposal, Lawful Immigrants Might Be Inclined To Shun Health Benefits,” by Christina Jewett and Melissa Bailey and Paula Andalo

Anna Edney: Vox.com’s “The Blockbuster Fight Over This Obscure Federal Program Explains America’s Drug Prices,” by Dylan Scott

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.