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posted by Fnord666 on Wednesday December 20 2017, @04:21PM   Printer-friendly
from the who-defines-serious? dept.

The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):

To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.

"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."

FDA draft guidance (8 pages).

Also at Ars Technica and STAT News.

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  • (Score: 3, Insightful) by DannyB on Wednesday December 20 2017, @05:02PM (10 children)

    by DannyB (5839) Subscriber Badge on Wednesday December 20 2017, @05:02PM (#612363) Journal

    I thought Republicans were against any kind of regulation?

    The same kind of arguments for regulating homeopathetic products would apply to regulating polluters of our air and water. Or regulating those causing climate change. Or regulating abuses of internet access by ISPs.

    Is some regulation is more equal than other forms of regulation? If there is some insight I am missing, I would be happy to be informed.

    None of this is about taxes.

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  • (Score: 5, Funny) by Anonymous Coward on Wednesday December 20 2017, @05:06PM

    by Anonymous Coward on Wednesday December 20 2017, @05:06PM (#612365)

    Well, if you dilute the regulation, say, 1to 100, it becomes even more effective, because of the "memory" of regulation. Republican regulation. Just wait 'til this Congress applies the same thinking to Social Security!

  • (Score: 2) by The Mighty Buzzard on Wednesday December 20 2017, @07:21PM (7 children)

    by The Mighty Buzzard (18) Subscriber Badge <themightybuzzard@proton.me> on Wednesday December 20 2017, @07:21PM (#612464) Homepage Journal

    Is some regulation is more equal than other forms of regulation?

    Well, I should certainly hope so. I expect you're looking for ISPs to be regulated but you disapprove of the Fairness Doctrine, for instance. Regulation should always be as limited as is possible; best if it can be absent entirely but this is not always practical.

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    • (Score: 0) by Anonymous Coward on Wednesday December 20 2017, @09:49PM

      by Anonymous Coward on Wednesday December 20 2017, @09:49PM (#612564)

      Projecting much? Typical bird brain.

    • (Score: 2) by DannyB on Wednesday December 20 2017, @09:54PM

      by DannyB (5839) Subscriber Badge on Wednesday December 20 2017, @09:54PM (#612568) Journal

      I agree Regulation should be as limited as possible. But not absent when it is necessary. Any necessary regulation should be strong enough to accomplish its purpose, and be for the public good.

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    • (Score: 2) by DannyB on Wednesday December 20 2017, @10:04PM (4 children)

      by DannyB (5839) Subscriber Badge on Wednesday December 20 2017, @10:04PM (#612574) Journal

      I do want ISPs to be regulated. There shouldn't be "fast lanes" paid for by destinations. Fast Lanes should be something that the ISP sells to their own customers. But the necessity of offering suggests that the ISP isn't doing its job of building out its infrastructure to support its customer base.

      ISPs should be dumb pipes. Period. Where my packets go to or come from is none of the ISP's business. The amount of incoming or outgoing bandwidth that I use should cost ME money, not the other end of the connection, to the disadvantage of everyone else. Netflix already pays handsomely for its bandwidth. The ISP should not discriminate based on where my packets go, nor what they contain. Only to the extent that it is necessary to manage their network fairly for all users.

      Basically, ISPs brought on the need for regulation by their own doing. They shouldn't cry about it now. Even with the net neutrality repeal, I suspect in time that things are going to swing back the other way. And hard.

      I have mixed feeling about the Fairness Doctrine. On one hand, not all views are equally valid.

      A public controversy about whether the sun rises in the east vs the sun rises in the west should not give equal weight to both views. Especially if the controversy is created by trolls for commercial interest to the detriment of everyone else.

      After seeing what FoxNews started as, and how CNN and others later became equally as bad, I'm not sure I can trust any of them to be good actors in presenting or even recognizing what is fair.

      On the other hand, simple controversial views should be covered equally. Issues like taxes. Social Security. Military Spending. Gun Control. Abortions. These are highly charged issues, and worthy of public debate. But are we even capable of having a debate any longer?

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      • (Score: 4, Insightful) by The Mighty Buzzard on Wednesday December 20 2017, @10:46PM (3 children)

        by The Mighty Buzzard (18) Subscriber Badge <themightybuzzard@proton.me> on Wednesday December 20 2017, @10:46PM (#612596) Homepage Journal

        After seeing what FoxNews started as, and how CNN and others later became equally as bad, I'm not sure I can trust any of them to be good actors in presenting or even recognizing what is fair.

        Outstanding. That's an important step on the path to wisdom. Try for forgetting the notion of "fair" in regards to journalism next. Your "fair" is always going to be someone else's "tyrannical". Just accept that all media sources are biased and seek a variety of ideological sources that often commit good journalism. The ones you disagree with will likely even expand your thinking more than the ones you agree with. If nothing else, they'll leave you with a better thought out position.

        But are we even capable of having a debate any longer?

        Yes but with a huge caveat. There are extremely powerful forces who have vested interests in us not engaging in civil debate. It allows them to frame any issue any way they want and count on large, predictable amounts of unthinking support and opposition.

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        • (Score: 2) by Azuma Hazuki on Thursday December 21 2017, @06:32AM

          by Azuma Hazuki (5086) on Thursday December 21 2017, @06:32AM (#612717) Journal

          You're so close. Soooooo close. Keep following this line of thought.

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        • (Score: 0) by Anonymous Coward on Monday December 25 2017, @03:55AM (1 child)

          by Anonymous Coward on Monday December 25 2017, @03:55AM (#614007)

          Wait, there are media source that often commit good journalism? Are you sure these sources actually exist?

  • (Score: 2) by VLM on Wednesday December 20 2017, @11:46PM

    by VLM (445) on Wednesday December 20 2017, @11:46PM (#612615)

    Its a classic neocon vs alt right argument. Also there's usually a distinction between criminal fraud and being really good at making business deals, standards of corporate contract law like having a meeting of the minds, also there's some subtle distinction between monopolies (ISPs?) and commodities (distilled water masquerading as medicine). So beyond a fox news level of argument of "regulation = bad" its nuanced.

    As a gross simplification if you take classical republicanism and add a little common sense social stuff you end up with "nationalist socialism" which is actually a pretty good idea although it seems to have a bit of a historical reputation issue.

    Of course if you want it simplified into convenient straw dog format, then it does in fact simplify down to "regulation is badthink", sure, although thats inapplicable in any real form.