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house Bill H.R. 639

Should New Drugs Be Approved (Or Denied) Faster?

Argument in favor

Would help ensure that new treatment options reach patients in a timely manner.

BananaNeil's Opinion
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03/05/2015
60 days is more than enough time to put together a valid approval. Lets advance human medicine! And, honestly, I would rather the DEA spent time approving drugs that can help people than sending people to prison for things like possession of marijuana.
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Stormcrow's Opinion
···
02/18/2015
This is a reasonable streamline of the process of drug approval. Follow up by adding more transparency in the approval process by both the FDA and the DEA. For example, an up to the minute current online database on submissions, approvals, denials, including details that are freely accessible by the public.
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Inez's Opinion
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03/14/2015
There have been so many drugs approve and later proven to be bad. So the process now in effect isn't working. I believe individuals should be given all facts concerning the drug, let them make up their mind signing a form releasing anyone from any legal retribution.
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Argument opposed

Rushing approval of experimental medicines has the potential to backfire widely and lethally.

Debra's Opinion
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02/17/2015
All drugs and vaccines need to be proven SAFE before given to the uninformed. We trust our doctors and doctors should be able to TRUST the pharma companies. This can only be done through thorough drug testing.
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John's Opinion
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02/22/2015
Drugs must be tested and approved before sale.
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ThomasParker's Opinion
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05/19/2015
The FDA already does enough harm by not allowing many helpful drugs from coming to market. Instead of involving other agencies or trying to fix this with a bandaid, we should limit the FDA to being an informative bureau without any power to regulate which drugs can and cannot be purchased and sold.
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What is House Bill H.R. 639?

When pharmaceutical companies want to introduce a new medicine to U.S. patients, it must first go to the Food & Drug Administration (FDA) for approval. After this, these medicines go to the Drug Enforcement Agency (DEA), where that agency must approve them, too. 

This bill aims to accelerate the approval process by requiring the DEA to come to a scheduling decision within 60 days of a drug product passing FDA approval. 

This legislation would also speed up the process to bring new drugs under a clinical trial. The DEA would be given a 180 day window to approve or deny an application to manufacture a controlled substance (Schedule III, IV or V) for clinical trial. 

Impact

Sick patients, new pharmaceuticals and other medicines awaiting DEA approval, healthcare providers, researchers in clinical trials, the FDA, and the DEA.

Cost of House Bill H.R. 639

A CBO cost is currently unavailable, though if enacted, an increase in labor hours at the DEA would seem likely, and this might in turn raise the DEA's budget.

More Information

Of Note:

According to an Op-Ed in The Hill in support of a previous version of this bill from the 113th Congress:

"Between 1997-1999 and 2009-2013, the time between FDA approval of a medicine and DEA’s final scheduling increased from an average of 49 days to an average of 238 days, an almost five-fold increase."

Media:




(Photo Credit:  Flickr user kaibara87

AKA

Improving Regulatory Transparency for New Medical Therapies Act

Official Title

To amend the Controlled Substances Act with respect to drug scheduling recommendations by the Secretary of Health and Human Services, and with respect to registration of manufacturers and distributors seeking to conduct clinical testing.

bill Progress


  • EnactedNovember 25th, 2015
    The President signed this bill into law
  • The senate Passed October 26th, 2015
    Passed by Voice Vote
      senate Committees
      Committee on Health, Education, Labor, and Pensions
  • The house Passed March 16th, 2015
    Passed by Voice Vote
      house Committees
      Committee on Energy and Commerce
      Health
      Committee on the Judiciary
      Crime, Terrorism and Homeland Security
    IntroducedFebruary 2nd, 2015

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    60 days is more than enough time to put together a valid approval. Lets advance human medicine! And, honestly, I would rather the DEA spent time approving drugs that can help people than sending people to prison for things like possession of marijuana.
    Like (9)
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    Share
    All drugs and vaccines need to be proven SAFE before given to the uninformed. We trust our doctors and doctors should be able to TRUST the pharma companies. This can only be done through thorough drug testing.
    Like (8)
    Follow
    Share
    Drugs must be tested and approved before sale.
    Like (5)
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    The FDA already does enough harm by not allowing many helpful drugs from coming to market. Instead of involving other agencies or trying to fix this with a bandaid, we should limit the FDA to being an informative bureau without any power to regulate which drugs can and cannot be purchased and sold.
    Like (3)
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    This is a reasonable streamline of the process of drug approval. Follow up by adding more transparency in the approval process by both the FDA and the DEA. For example, an up to the minute current online database on submissions, approvals, denials, including details that are freely accessible by the public.
    Like (2)
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    There have been so many drugs approve and later proven to be bad. So the process now in effect isn't working. I believe individuals should be given all facts concerning the drug, let them make up their mind signing a form releasing anyone from any legal retribution.
    Like (1)
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    I'm in medicine. Two words: DUE DILIGENCE.
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    Take your time with new drugs
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    Public safety should be a priority, not a timeline.
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    Drug companies should NOT be allowed to push through drugs before adequate testing for efficacy and safety is performed. Too many people are harmed by the drug companies' desire for quick profit for their shareholders. There should, however, be a way for people in dire and immediate need of a drug to petition for inclusion in human trials of the drug.
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    Increasing the speed of approval would be a good idea because it lets the market decide for or against a treatment, rather than large government oversight that typically takes excessive amounts of time to change.
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    So many drugs as of late have been rushed through , then taken off the market because they are dangerous. Safety needs ro be the key!
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    Minimum government. Maximum FREEDOM.
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    As a hospice nurse, I see many people die waiting for a drug to be approved. I agree the process to approve new drugs should be slow enough to ensure the drugs are safe, but currently, the process is too long.
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    Remember Thalidomide. On this issue it pays to be careful
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    Rushing ANY medication into approval of denial, could have any dangerous and lethal effects on patients, the drugs and their side effects need to be well researched and documented before FDA approval or denial
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    These are smart and calculated time frames to work under.
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    The FDA is an unwieldy behemoth that can delay important treatment by years of not decades. Appointing senators and congressmen that actually believe in science to scientific committees might make some improvements to the process, but getting some of the lawyers out of the way definitely would.
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    Must insure safety first.
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    I suffer from chronic migraines, in upwards of 7 days a week. I think medication should be available sooner because some of us need more options to be able to live productive lives.
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