THE PROGNOSIS

President Trump's administration acknowledges the promise of medication-assisted treatment for the huge population of Americans struggling with opioid addiction – a dire situation the president has declared a public health emergency.

But his Food and Drug Administration is throwing a major roadblock in the way of getting more anti-opioid treatments on the market, one drug maker is charging.

This morning, drug maker Braeburn will announce it has filed a petition asking the FDA to deny the medication Sublocade a special status giving its maker, Indivior, exclusive rights to sell the drug until 2024. Sublocade is a long-acting, injectable version of buprenorphine, one of three approved drugs that are highly effective in helping people beat back opioid addiction.

The FDA is considering giving the 2017 version of Sublocade "orphan drug status" – a special protection typically given only for drugs that treat extremely rare diseases as a way of encouraging the development of less-profitable products -- even though the medication could be used by as many as 2 million Americans who abuse opioids. That would mean Braeburn wouldn't be able to sell its similar version of the medication, Brixadi, for several more years. The company argues that’s unfair, considering opioid addiction is hardly a rare disease and Indivior has already collected large profits from oral versions of buprenorphine.

“You can’t say opioid use disorder is an orphan disease because you have over 2 million patients who have that disease,” Braeburn CEO Mike Derkacz told me yesterday.

While “orphan drug” designations have been hugely helpful for patients whose illnesses might be otherwise ignored, drug makers have also manipulated the system to maximize profits.

Let’s zoom out for a moment. There’s broad consensus that combining counseling services with medication-assisted treatment is the best way to help people who are addicted to prescription painkillers, heroin or the synthetic opioid fentanyl.

Health and Human Services Secretary Alex Azar has stressed it must be a central part of the administration’s response to the opioid crisis, and in February the FDA issued guidance praising the effectiveness of buprenorphine and giving advice on how pharmaceutical makers could get more such medications approved.

Yet recent evidence suggests anti-opioid medications aren’t widely available. Even though buprenorphine, methadone and naltrexone have all been found safe and effective, most people who could benefit from the treatments don’t get them and they’re not typically made available in residential treatment facilities, according to a report last month by the National Academies of Sciences, Engineering and Medicine.

Which brings us back to the dispute between pharmaceutical companies Braeburn and Indivior.

Indivior first received orphan drug status back in the 1990s for its medication Subutex, an oral version of buprenorphine. The company was able to receive the designation by arguing it couldn’t reasonably expect to recover its costs of developing the drug – an alternative pathway to getting orphan drug status that has been used only two other times.

But not only did Indivior’s earnings from Subutex subsequently far exceed expectations, the company has been able to get the orphan drug status also applied to its injectable medication, Sublocade, because they both contain buprenorphine. When I asked Indivior for comment, the company sent a statement praising the medication and linking to studies showing its effectiveness, without addressing the orphan drug designation.

“Indivior is committed to helping the patients, families and communities impacted by the opioid epidemic, and delivering new treatment options for moderate to severe opioid use disorder,” Indivior said in a statement.

This much is true: The FDA has wide latitude in whether to grant orphan drug status. And because the status applies to molecules rather than specific drugs, companies can obtain orphan drug status for newer versions of the same drug, if they show they’ve improved the drug in some meaningful way. Congress recently codified this approach in the 2017 FDA Reauthorization Act.

An FDA spokeswoman confirmed the agency had received Braeburn’s petition but declined to comment publicly on the matter. She directed Health 202 to previous statements in which the agency promised to promote medication-assisted treatment by issuing guidance for developing it, encouraging its use through policy changes and working to reduce stigma associated with such treatments.

“To help those suffering from opioid use disorder, the FDA is prioritizing new efforts to advance the development and use of safe and effective MAT,” the agency said.

But if FDA gives Sublocade orphan drug status – thereby giving it exclusive selling rights for five more years – it would restrict similar treatments from coming online during what is widely acknowledged to be a public health crisis, affecting millions of people. That goes against the whole intent of the 1983 Orphan Drug Act, passed by Congress specifically to help people on the margins.

“It’s very unusual or precedented – in my recollection – that a population for what is perceived to be a rare disease would grow to a point where it ends up being 10 times the cap for orphan drug designation,” said Bernard Munos, a former corporate strategy advisor at Eli Lilly.

Not just Braeburn, but all companies who want to sell buprenorphine-only products would be affected. Derkacz contends it would result in fewer anti-opioid medications being available even as the public health agencies try to combat the epidemic.

“We want to make sure stakeholders really understand what is at stake here,” Derkacz said. “Having industry doing this nonsensical evergreening stuff with the Orphan Drug Act isn’t good for anybody.”

Correction: An earlier version incorrectly stated Sublocade had been granted orphan drug status. The FDA said Tuesday the approval is still pending.

AHH, OOF and OUCH

AHH: The Justice Department has filed a motion to expedite oral arguments in the case over the constitutionality of the Affordable Care Act, requesting that arguments in the 5th Circuit Court of appeals be scheduled the week of July 8, Politico’s Paul Demko reports.

The administration said in the filing that other parties in the appeal are not opposed to the timeline. The motion comes just weeks after the Trump administration moved to urge the appeals court to fully invalidate the ACA after earlier arguing that just certain provisions should be deemed unconstitutional. A group of 16 mostly Democratic-led states and the District of Columbia have appealed the December ruling by a federal judge in Texas that the health care law is unconstitutional because the individual mandate was invalid.

OOF: One of the issues Trump wants to revive -- his family separation policy -- is also one of his least-popular.

Part of what led to the firing of Homeland Security Secretary Kirstjen Nielsen was reportedly tension between her and the president over Trump’s support for reinstating the administration’s family separation policy. NBC News’s Julia Ainsley and Geoff Bennet report Trump for months has been pushing his administration to revive the separation of families at the U.S. border with Mexico. They add an administration official said Trump believes the policy was effective in curbing asylum-seekers.

But Nielsen was against the push, telling the president “that federal court orders prohibited the Department of Homeland Security from reinstating the policy, and that he would be reversing his own executive order from June that ended family separations,” Julia and Geoff write.

“It is not clear the extent to which the separation policy actually contributed to deterring families from arriving at the border, though, according to multiple administration officials, that was explicitly one of the points of the program,” our Post colleague Philip Bump reports. “What is clear, though, is the policy of pulling apart families at the border is one of the least popular Trump has proposed during his presidency.”

Even Republicans were against the policy. In Quinnipiac University and CNN polls, about two-thirds of Americans said they were opposed to the policy, including a third of Republicans.

OUCH: There were 78 new measles cases reported in the first week of April, according to the Centers for Disease Control and Prevention, bringing the total to 465 confirmed cases this year. It’s already the highest number of cases in the last five years, our Post colleagues Reis Thebault reports.

As of the latest update, measles has been reported in more than a third of states, and the illnesses have mostly been occurring in children.

Public health experts have continued to point fingers at the pockets of unvaccinated children in the country, in part a result of an anti-vaccination movement that has spread because of misinformation.

Peter Hotez, an infectious-disease expert at the Baylor College of Medicine reacted to the latest CDC measles update on Twitter:

HEALTH ON THE HILL

— Executives from top five pharmacy benefit managers will testify before the Senate Finance Committee this morning at its latest high-profile hearing on the cost of prescription drugs. 

The Trump administration says its proposed ban on the rebates that drug manufacturers pay to these firms that manage pharmacy insurance would help lower drug costs. But it could also mean seniors pay somewhat more. Individual premiums for Medicare prescription drug insurance could jump 19 percent next year under the move, while the monthly cost to individual seniors could rise by about $6, our Post colleague Christopher Rowland writes.

"It is not a large amount but would not go unnoticed by seniors on fixed incomes," Chris writes. "It would also give Democrats an opening to slam Trump as insensitive to the elderly in places like Florida, Pennsylvania, Ohio and Wisconsin — states that Trump must win to regain the White House."

But the administration is taking steps that could delay premium spikes on Medicare prescription drug beneficiaries until after President Trump’s 2020 reelection bid, Chris reports. The Centers for Medicare and Medicaid Services has said it would take a year or more to take rebates out of the Medicare system, providing companies time to figure out logistics.

Executives at today’s hearing are expected to argue the proposed rebate rule would mean premium hikes for all seniors, and some of the companies teased their comments yesterday, the last day of public comment on the proposed rule.

“It will increase premiums for seniors, but do nothing to force drug manufacturers to lower prices,’’ said CVS Health in its comment letter. The company, which is the umbrella organization that includes pharmacy benefit manager CVS Caremark, said it may not be realistic for rebates to be removed by 2020 or even 2022.

— Almost a dozen Democratic senators have launched a probe into marketing practices by e-cigarette maker Juul Labs, seeking more information about the company and its deal with Marlboro maker Altria.

Sens. Elizabeth Warren (D-Mass.), Ron Wyden (D-Ore.), Richard Blumenthal (D-Conn.) and Dick Durbin (D-Ill.) and others said in a letter yesterday that they'd look into whether Juul is violating regulations and promises made to the FDA ahead of Altria’s purchase of a 35 percent stake in the e-cigarette company, CNBC’s Angelica LaVito reports.

“While JUUL has promised to address youth vaping through its modest voluntary efforts, by accepting $12.8 billion from Altria—a tobacco giant with such a disturbing record of deceptive marketing to hook children onto cigarettes —JUUL has lost what little remaining credibility the company had when it claimed to care about the public health,” the senators wrote.

In a statement, a Juul spokesman said the company welcomes “the opportunity to share information” about its efforts. “We agree that companies such as ours must step up with meaningful measures to limit access and appeal of vapor products to young people,” the spokesman said. “That’s exactly what we’ve done, and we will do more to combat teen use to save the harm-reduction opportunity for the 34 million adult smokers in the United States.”

— Sen. Bernie Sanders (I-Vt.) is set to introduce tomorrow a revised version of his “Medicare for all” bill, a measure that would establish a single-payer government-run health care program.

Sanders, one of a growing number of Democratic candidates for president, was the first to introduce a Medicare-for-all bill, back in 2017. Many now-presidential contenders, including Sens. Cory Booker (D-N.J.), Kirsten Gillibrand (D-N.Y.), Kamala Harris (D-Calif.) and Elizabeth Warren (D-Mass.) have signed onto the legislation.

TRUMP TEMPERATURE

— The 2020 Democratic candidates have been touting their policy proposals on social media as much as in their stump speeches, and our colleagues Kevin Schaul and Kevin Uhrmacher put together an in-depth interactive graphic that breaks down what they’ve been running on so far.

Of the 15 Democrats included in the analysis, a look at policy-related posts on social media found a range of 2 to 23 percent of candidates’ policy posts have focused on health care. Sanders leads the list with 23 percent of his posts about policy including a mention of health care, including references to things like Medicare-for-all, the opioid crisis and women’s health. Inslee trails the group, our colleagues found: 2 percent of his policy-related posts are about health care.

Former congressman John Delaney (D-Md.) mentioned health care in 20 percent of his policy posts, Sen. Kristen Gillibrand (D-N.Y.) in 12 percent of her policy posts and Sen. Elizabeth Warren (D-Mass.) in 4 percent of her policy-related social media posts, to name a few. Our colleagues also tracked other issues related to health care, including gun control, social justice issues and criminal justice. Check out some of those results below:

AGENCY ALERT

— Acting Food and Drug Administrator Ned Sharpless shared a letter he sent to staff as he took the helm of the agency yesterday, announcing he’d be addressing all its members at a meeting on Tuesday.

He thanked Scott Gottlieb, who left the agency on Friday, starting a new gig at the American Enterprise Institute.

Sharpless, who was the National Cancer Institute director, said it was a “privilege for me to now lead FDA, given this agency’s long tradition of promoting innovation.”

— And here are a few more good reads: 

Politics
The California Democrat will try to parlay youth and liberal policies but will have to battle to become better known in early-voting states.
Annie Linskey
Five of the pharmacy benefit manager industry's top executives head to Capitol Hill this week for a pair of back-to-back hearings on high drug prices.
Stat
MEDICAL MISSIVES
ER visits for children who attempted suicide or had suicidal thoughts doubled over a nine-year period in the USA, a new study says.
USA Today
Health & Science
With climate change, some of the parasites will remain active through winter and expand their habitats into new areas.
Rosa da Silva
INDUSTRY RX
The lack of transparency puts patients at risk, some say. Institutions say disclosure could scare some people away from seeking needed medical care.
New York Times
Bayer says hundreds of studies prove it safe, but plaintiffs claim the research was skewed by company cooperation with scientists. Two juries have found in favor of plaintiffs who developed lymphoma.
Wall Street Journal
STATE SCAN
There have been 285 cases of measles in Brooklyn and Queens since October, most of them involving members of the Orthodox Jewish community.
NBC News
DAYBOOK

Today

  • The Senate Judiciary Committee holds a hearing on "The Need to Pass the Pain-Capable Unborn Child Protection Act."
  • The Senate Finance Committee holds a hearing on drug pricing.

Coming Up

  • The House Energy and Commerce Subcommittee on Oversight and Investigations holds a hearing on the rising cost of insulin on Wednesday.
SUGAR RUSH

Why Kirstjen Nielsen’s loyalty to Trump wasn’t enough to save her job: