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Sunday, May 26, 2024

An attempt to speed up drug approval



The House plans to vote Wednesday on a $6.3 billion bill aimed at speeding federal approval of drugs and medical devices and boosting biomedical research.

The legislation, a priority for congressional leaders in the lame-duck session, seeks to streamline how federal regulators assess the safety of new treatments and let them reach markets more quickly. It provides new money for the National Institutes of Health and Food and Drug Administration, including funding for the White House’s cancer moonshot and precision medicine initiatives.

The bill also would seek $1 billion in grants to states to fight opioid abuse.

Rep. Fred Upton, R-Mich., who chairs the House Energy and Commerce Committee, announced details of the draft bill Saturday along with Sen. Lamar Alexander, R-Tenn., chair of the Senate Committee on Health, Education, Labor and Pensions. They described the legislation as an “innovation game-changer.”

“America’s patients are waiting on us,” the two lawmakers said in a statement.

Republicans said the measure was final. But aides to Democrats — they are the minority party in both the House and Senate — said negotiations were continuing. Democrats were seeking additional changes to garner “strong bipartisan support,” according to a Democrat speaking for the House committee.

The draft bill includes several provisions pushed in part by Democrats aimed at addressing mental health issues, such as increasing access to treatment for children and on college campuses.

A version of the bill previously passed the House but has been on hold for a year as Democrats and Republicans sparred over levels of NIH spending. The latest draft bill would provide $4.8 billion to NIH and $500 million to the FDA.

It would be paid at least in part by selling oil from the nation’s Strategic Petroleum Reserve.

Sen. Patty Murray, the top Democrat on the Senate panel, had pushed for a broader bill that included provisions on opioid-addiction treatment as well as mental health reform.

Senate Majority Leader Mitch McConnell, R-Ky., has said once the House acts on the bill the Senate will follow before the end of December.

Copyright © 2016 Capitol Hill Blue

Copyright  © 2016 The Associated Press. All Rights Reserved

1 thought on “An attempt to speed up drug approval”

  1. How about limiting what drug companies can charge for a drug to some sort of reasonable dollar amount. The company that makes my MS medication charges over $65,000 per year for a drug that has been in use for decades and costs them less than 10 cents per pill to make. Medicare catastrophic care charges the user 5%, so altogether it works out to over $6000 per year, simply because they set the retail price to anything they want. (And all the competing MS drugs cost about the same.)

    Thus loophole drains huge amounts of money out of insurers and Medicare into the drug company’s bank accounts. For a reality check, my blood pressure prescription is $89/month but Medicare gives it for free because they think it saves them money to keep me healthy!

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