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Congress and Agency Actions in the News
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Politico – Pulse - HELP Committee Split on Who's to Blame for High Drug Costs

  • There was a lot of finger-pointing yesterday as the Senate HELP Committee heard testimony from various industry representatives about who's responsible for the nation's high drug prices, POLITICO's Sarah Karlin-Smith reports.
  • HELP Committee Chairman Alexander focused his questions on the role of pharmacy benefits managers and the drug rebate system, asking whether the practice of PBM's negotiating these discounts on drugs is driving up prices, not translating to consumer savings.
  •  Meanwhile, committee ranking member Patty Murray seemed most concerned about brand drug company tactics used to block competition, including techniques they use extend their market monopolies well beyond the initial FDA-granted exclusivity period or beyond the periods of patent protection for the truly innovative parts of the product.
  •  Ultimately, lawmakers on both sides of the aisle were enraged about the cost of drugs, Sarah tells PULSE, but with little agreement as to the root causes, legislative solutions may remain in the distance. The committee plans to hold at least one more hearing on drug pricing this year.
  •  Catch Sarah on NPR's 1A today, discussing the role of the U.S. drug czar and how the administration is approaching the opioid crisis. 

Politico - Marino Out as Trump's Drug Czar Nominee

  • President Donald Trump on Tuesday announced that Rep. Tom Marino has withdrawn as the administration's drug czar nominee, shortly after media reports revealed how the lawmaker championed a law that hobbled federal efforts to combat opioid abuse.
  • "Rep.Tom Marino has informed me that he is withdrawing his name from consideration as drug czar. Tom is a fine man and a great Congressman!" Trump tweeted on Tuesday morning.


Politico – PulseDems Push DEA, HHS on Washington Post/CBS investigation.

  • Sens. Sherrod Brown, Dick Durbin and Ed Markey put out a letter this morning that asks the agencies to offer a status update on the law that was the subject of the media outlets' investigation. The WaPo/CBS report suggested that the pharma industry helped push the law in a deliberate attempt to weaken the DEA's enforcement of opioid misuse.
  • "We are concerned by these recent news reports, and we write to request that you immediately provide Congress with an update on the law’s impact on the war against addiction," the senators write to Acting DEA Administrator Robert Patterson and Acting HHS Secretary Eric Hargan. "We want to ensure the [DEA] and other related agencies have all of the tools necessary to fight this epidemic."
  •  The senators specifically note that a joint HHS-DEA report about drug misuse that was due to Congress on April 16 is more than six months overdue.


Politico – Pulse

  • Speaking on the Senate floor Monday evening, Sen. Orrin Hatch said DEA and the Justice Department not only signed off on the bill, but provided lawmakers with some of the key language now criticized by the media report as hampering DEA's enforcement abilities. Then-President Barack Obama signed the bill into law on the advice of his DEA administration, Hatch added.
  • The Utah Republican said opponents of the Trump administration rewrote the history of the bill to sink Marino's nomination to be the country's "drug czar" — aided by a group of disgruntled ex-DEA employees.
  •  Hatch also dismissed the notion that lobbying from drug distributors or manufacturers influenced the bill's passage. "I reject the notion that there was some sort of sinister conspiracy at play," Hatch said.
  •  PhRMA also pushed back on the story. The industry group said it did not support or lobby in favor of the Ensuring Patient Access and Effective Drug Enforcement Act, S. 483 (114). The Post/CBS story has a chart that lists $40.8 million in PhRMA lobbying expenses between 2014 and 2016, but there's no indication of how much, if any, it spent on S. 483.
  •  Under-the-radar SCOTUS patent case could have big implications for drug prices, access. That's according to the Initiative for Medicines, Access, & Knowledge (I-MAK), which is out with a new paper on a constitutional challenge to the Patent Trial and Appeals Board. The group says that the board, known as the PTAB, is essential
  •  "The Supreme Court's decision on whether the PTAB can continue to review and appropriately invalidate unmerited patents is a critical upcoming decision that will have long-term impact on drug prices," the group writes. "Unmerited patents result in higher drug prices, keeping lifesaving medicines out of reach of people who need them." 

Politico – Ehealth

  • The Wall Street Journal is reporting that VA Secretary David Shulkin has interviewed with the White House to replace Tom Price as head of HHS. He’s one of several candidates whose names are circulating, including CMS Administrator Seema Verma, FDA Commissioner Scott Gottlieb, former Pennsylvania Sen. Rick Santorum and former Louisiana Gov. Bobby Jindal.
  • What Shulkin told Morning eHealth after an ATA event earlier this month: “I’m very happy at VA. But I serve at the president’s will, and whatever the president needs me for, I would do. But I’m very happy where I am.” 
  • Shulkin has been very tech friendly at the VA. He is opting to replace its VistA EHR with a Cerner system and taken steps to expand the VA’s reach of telemedicine by loosening when providers can see patient through the technology.
  • CVS, EPIC TEAM UP ON DRUG PRICING INFORMATION: Two of the biggest names in retail pharmacy and health IT announced a partnership that will make patients' out-of-pocket drug costs more apparent during visits to the doctor. CVS Health will use Epic's Healthy Planet technology to navigate the complex matrix of health plans, drug formularies and cost-sharing arrangements so patients know how much they'll pay before they get to a pharmacy. It could also help prescribers identify the lowest-cost drug, if appropriate. 
  • The partnership, which will be available for Epic-using clinicians on patients who have CVS as their pharmacy benefits manager, will also funnel more clinical information on patients to pharmacists while feeding pharmacy purchases — like over-the-counter medications and medical equipment — into EHRs.


APhA - FDA Urges Clinicians to Help Limit Opioid Prescriptions

  • Speaking at a special session of the annual meeting of the National Academy of Medicine, FDA Commissioner Scott Gottlieb, MD, asked health care providers to help the agency find ways to limit both the number of opioid prescriptions and the duration of those prescriptions.
  • "Some limits on duration of use are an inevitability," said Gottlieb. He noted the pharmaceutical industry is supporting limits to duration of use, the supply chain has imposed restrictions, and about 20 states have put limits on first-time opioid prescriptions.
  • FDA's authority to more strictly regulate opioid prescribing is currently somewhat limited, but the agency is going to do what it can to reduce the total exposure to opioids, said Gottlieb. He called on clinicians to help FDA "build expert guidelines" that would spell out the appropriate duration of use for different clinical circumstances.
  • Those guidelines could then be incorporated into drug labeling.
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