Monday, December 12, 2016

CONGRESS - I the FDA Getting a Funding Increase?

"Major health bill would fund medical research, hasten FDA approvals" PBS NewsHour 12/6/2016


SUMMARY:  In Congress, lawmakers are close to passing a major bill that would increase funding for the FDA, the NIH, and the effort to fight opioid abuse.  The measure would also introduce more flexible standards for drug approvals, reducing the need for costly clinical trials.  Lisa Desjardins reports and Hari Sreenivasan speaks with Sydney Lupkin of Kaiser Health News and Ed Silverman of STAT News for more.

HARI SREENIVASAN (NewsHour):  While most attention has been focused on the action at Trump Tower in Manhattan, lawmakers at the U.S. Capitol are close to passing a major bill that would lead to big changes for drug approval, medical research and much more.

Lisa Desjardins kicks off our coverage with this report.

LISA DESJARDINS (NewsHour):  Weeks from the end of its term, Congress is on the verge of passing a whopper of a bipartisan bill.

SEN. MITCH MCCONNELL, Majority Leader:  This legislation promotes critical investments in research.

SEN. HARRY REID, Minority Leader:  We're going to pass the Cures Act.

LISA DESJARDINS:  A godsend to supporters, a spending spree or corporate giveaway to critics, here's a look at the 21st century medical cures bill.  It is a mammoth $6 billion measure, now four major pieces of legislation packed in one, starting with a giant nearly $5 billion shot of funding to the National Institutes of Health for research.

That includes almost $2 billion for the 'Moonshot' effort led by Vice President Joe Biden to find a cure for cancer praised in a White House Web video today.

VICE PRESIDENT JOSEPH BIDEN:  A lot of lives will be affected by this bill, God willing.

LISA DESJARDINS:  That's one reason many Democrats are on board.  Another?  The bill now includes $1 billion to address the opioid epidemic.  It's a national crisis that's been in funding limbo for months.

A third major piece?  Mental health reform, including a new assistant secretary position for mental health and substance use.

Republican Tim Murphy, a psychologist, has pushed for this for years.

REP.  TIM MURPHY (R-Pa.):  This doesn't end the scourge of mental illness, but this puts us on a path to really make some substantial change and give people help.

LISA DESJARDINS:  Now for what Republican leaders love, the bill's core, reforming and speeding up the Food and Drug Administration's drug approval process.

To some, that's modernization that cuts red tape, but to others it's a safety risk.  And some lawmakers see it as a gift to drug companies.

Those voices are led by Massachusetts Senator Elizabeth Warren.

SEN.  ELIZABETH WARREN (D-Mass.):  I cannot vote for this bill.  I will fight it, because I know the difference between compromise and extortion.

LISA DESJARDINS:  But she is in the minority.  The bill has received bipartisan support in Congress so far, and the president plans to sign it into law.

For the PBS NewsHour, I'm Lisa Desjardins.

HARI SREENIVASAN:  Let's dive a little deeper now into this bill, what would change, and some of the criticisms around it.

For that, we're joined by two reporters who have covered this field extensively, Sydney Lupkin of Kaiser Health News; and Ed Silverman, senior writer with STAT News, a site covering medicine and health care.

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