Overnight Health Care — Sponsored by PCMA — FDA tries to shame companies it says may delay generics

Overnight Health Care — Sponsored by PCMA — FDA tries to shame companies it says may delay generics
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Welcome to Overnight Health Care, sponsored by the Pharmaceutical Care Management Association.

It's Thursday in Washington where Republicans on Capitol Hill are trying to reach a deal to move ahead on immigration. Centrist Republicans want a vote on a bill to protect "Dreamers," but conservatives want a vote on a tougher immigration bill. And the fight could threaten the farm bill.

In the health care world, the focus is still on President TrumpDonald John TrumpSchiff: Surveillance warrant docs show that Nunes memo 'misrepresented and distorted these applications' Chicago detention facility under investigation following allegations of abuse of migrant children Ex-Trump aide: Surveillance warrants are 'complete ignorance' and 'insanity' MORE's drug pricing plan. Trump unveiled the plan in a speech last week, but it's dominated the health care conversation. Today, the FDA posted a list of drug companies it's accusing of gaming the system to delay generics, and Speaker Paul RyanPaul Davis RyanPelosi: 'Thug' Putin not welcome in Congress Interior fast tracks study of drilling's Arctic impact: report Dems unveil slate of measures to ratchet up pressure on Russia MORE (R-Wis.) gave some interesting hints on a drug pricing measure in Congress.

 

FDA names and shames.

One of the actions that administration officials touted last week in Trump's drug pricing plan is now under way; companies that some believe are "gaming" the system to delay generic drugs are being publicly shamed. 

The FDA published a list of drug companies that it said could trying to delay competition from cheaper generics.

"No patients should be priced out of medicines they need to support their health," FDA Commissioner Scott Gottlieb said in a statement.

"We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval," he added.

The details: The FDA published a list of 52 branded drugs whose makers could be using delay tactics to prevent generic drug companies from getting the samples they need to bring competitors to market. Various drug companies are called out on the list, including Celgene, Novartis and GlaxoSmithKline.

We've got more on the FDA's move here.

 

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Sponsored content - Pharmaceutical Care Management Association

Pharmacy benefit managers (PBMs) are hired by employers, unions, and government programs to negotiate aggressive discounts from drug companies and drugstores. PBMs continue to keep overall spending and out-of-pocket costs down despite massive price hikes by drugmakers. Learn how PBMs are part of the solution to reducing Rx costs at DrugBenefitSolutions.com.

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Lawmakers are looking at their own solution.

Speaker Paul Ryan (R-Wis.) pleasantly surprised some backers of a drug pricing bill in Congress by name-dropping it during an interview at a conference on Thursday.

What we know: Ryan said the Energy and Commerce Committee and the Judiciary Committee are working out a compromise on the legislation, known as the Creates Act.

What we don't know: Ryan did not get into details on what that a final bill could entail.

Some Republicans have previously objected to the bill on the grounds that it would invite frivolous lawsuits against drug companies. A compromise could seek to address that concern.

The bill has been stalled for months. There is support from members of both parties but there has also been an intense lobbying campaign against it from drug companies.

The measure seeks to crack down on delay tactics that drug companies use to slow the pace of cheaper generic drugs hitting the market.

Reason for skepticism: Most observers do not expect Congress to take any major action on drug prices in an election year. But there's always the chance the bill could hitch a ride on must-pass legislation.

We break it down here..

 

Right to Try legislation could get to President Trump's desk soon.

Momentum appeared to stall after both chambers passed different versions of Right to Try legislation.

But on Thursday, House Majority Leader Kevin McCarthyKevin Owen McCarthyHouse leaders clash over resolution backing ICE House backs resolution expressing support for ICE House GOP reverses, cancels vote on Dem bill to abolish ICE MORE (R-Calif.) announced the chamber would take up the Senate-passed bill next week.

What the bill does: It lets very sick patients request access to experimental drugs the Food and Drug Administration (FDA) hasn't approved, and lets them bypass the agency to do so.

The opposition: House Democrats largely voted against the measure, arguing that it could harm patient safety, concerns echoed by patient groups. They also contend the legislation provides "false hope" to patients because drugmakers aren't required to give patients the drug if they asked for it.

On the other side, supporters argue that terminally ill patients should have every tool at their disposal to help them.

Among the prominent supporters are groups backed by conservative mega-donors Charles and David Koch.

Read more on the interesting politics of the bill here. 

 

 

A watchdog group says CMS is pulling a disappearing trick with certain ObamaCare-related websites.

A Department of Health and Human Services web page that provided information about how Medicare coverage is affected by ObamaCare was removed from the federal Medicare website, according to a report from the Sunlight Foundation.

The report notes that in December 2017, a page titled "The Affordable Care Act & Medicare" was removed from the Medicare website without notice. It no longer exists.

A link that led to this page and descriptive text about the Affordable Care Act, called "Medicare & the Marketplace" were also removed from the Medicare website. It still exists, you just can't navigate there.

CMS response: "We decided, based on outdated content and low usage, that the ACA & Medicare page was no longer relevant or needed and took action to remove the page on 12/21/17," the agency told The Hill, and pointed to the current "Medicare & the Marketplace" page that they said was more "relevant."

This isn't the first time: The Sunlight Foundation has been publishing a series of reports about information being removed from federal health websites, including information about lesbian and bisexual health from the Office of Women's Health.

 

NIH Director Francis Collins says he has suspended a study on the possible benefits of moderate drinking after reports agency officials lobbied the beverage industry to fund it.

Concerns were raised after a recent New York Times story claimed NIH officials directly solicited donations from alcoholic beverage manufacturers to fund a $100 million study on the health effects of moderate alcohol consumption.

Key quote from Collins: "For NIH, our reputation is so critical. And if we are putting ourselves in a circumstance where that could be called into question, I felt like we had to look at that very seriously and come up with another strategy."

Why it matters: Public health experts argue such an arrangement would violate the agency's policies, which are designed to prevent outside influence on research results.

We have more on the controversy here.

 

Childbirth rates in the U.S. have fallen to a 30-year low, with only 3.8 million births last year.

New numbers from the Centers for Disease Control and Prevention show that the general fertility rate, or the number of live births per 1,000 women of childbearing age, was 60.2 percent, down 3 percent from 2016, reaching another record low for the nation.

Also in the report:

  • Researchers have been trying to figure out for years why the U.S. has faced declining fertility rates. "The rate has generally been below replacement since 1971," the CDC said.
  • The trend of women waiting longer to have children is continuing -- birth rates dropped for women aged 15–39, but increased for women aged 40–44.
  • Teen pregnancy rates are also dropping.

Click here for more on the report.

 

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Sponsored content - Pharmaceutical Care Management Association

Pharmacy benefit managers (PBMs) have outlined several policy solutions to ensure patients receive opioid prescriptions when safe and medically appropriate. One important solution would be requiring e-prescribing of controlled substances in Medicare (S. 2460 / H.R. 3528, the Every Prescription Conveyed Securely Act). A new study by the Opioid Safety Alliance finds this could save taxpayers $13 billion over 10 years.

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Roundup

The Food and Drug Administration (FDA) on Wednesday approved a medication to lessen the side effects of opioid withdrawal.

Health officials in the Democratic Republic of the Congo (DRC) said Thursday that an outbreak of the Ebola virus had spread to an important port city, opening a new and potentially deadly front in the epidemic.

President Trump donated his salary for the first quarter of 2018 to the Department of Veterans Affairs, the White House said Thursday.

 

What we're reading

Insurers figured out how to make a profit from ObamaCare last Yyear (Bloomberg)

There's a fight brewing between the Trump administration and drugmakers (The Washington Post Health 202 newsletter)

San Francisco will bring anti-addiction medication to users on the streets (The Washington Post)

 

State by state

Gov. LePage asks Maine court to toss suit aimed at forcing Medicaid expansion (Bangor Daily News)

Medicaid expansion would benefit 194,000 people in South Carolina, new study finds (Post and Courier)

ACLU, state spar before Supreme Court over Maine's ban on Medicaid-funded abortions (Portland Press Herald)