Stories
Slash Boxes
Comments

SoylentNews is people

Politics
posted by Fnord666 on Sunday May 20 2018, @01:12AM   Printer-friendly
from the dishonor-on-you,-dishonor-on-your-cow dept.

Submitted via IRC for Runaway1956

Update 5/17/2018: The FDA has now launched the website listing the names of brand name drugs and their makers who have stood in the way of generic drug companies trying to make more affordable alternatives. You can view the list here. It includes notable medications, such as Accutane (for acne), Methadone (used for opioid dependency), and Tracleer (to treat high blood pressure in the lungs). The brand name drug makers to be shamed includes big hitters such as Celgene Corp, GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, Gilead Sciences Inc, and Actelion Pharmaceuticals Ltd, now a Johnson & Johnson company. Our original story, published May 16, is unedited below.

The Food and Drug Administration plans this week to effectively begin publicly shaming brand-name drug companies that stand in the way of competitors trying to develop cheaper generic drugs.

FDA Commissioner Scott Gottlieb told reporters on Monday and Tuesday that the agency will unveil a website on Thursday, May 17 that names names of such companies. More specifically, the website will publicly reveal the identity of 50 branded drugs and their makers that have blocked generic development. The website will also be updated "on a continuous basis" to list additional names.

In fielding questions from reporters, Gottlieb denied that the effort was a form of public shaming. "I don't think this is publicly shaming," Gottlieb said, according to S&P Global Market Intelligence. "I think this is providing transparency in situations where we see certain obstacles to timely generic entry."

Source: https://arstechnica.com/science/2018/05/fda-to-start-naming-names-of-pharma-companies-blocking-cheaper-generics/


Original Submission

 
This discussion has been archived. No new comments can be posted.
Display Options Threshold/Breakthrough Mark All as Read Mark All as Unread
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
  • (Score: 5, Interesting) by MichaelDavidCrawford on Sunday May 20 2018, @01:45AM (4 children)

    My pdoc gave me the fantastically expensive Latuda for depression. It didn't do squat

    But amitryptiline has been generic for generations yet works really well

    But no one promotes it to doctors

    --
    Yes I Have No Bananas. [gofundme.com]
    Starting Score:    1  point
    Moderation   +3  
       Interesting=3, Total=3
    Extra 'Interesting' Modifier   0  
    Karma-Bonus Modifier   +1  

    Total Score:   5  
  • (Score: 1, Informative) by Anonymous Coward on Sunday May 20 2018, @02:40AM (3 children)

    by Anonymous Coward on Sunday May 20 2018, @02:40AM (#681745)

    What generic drug makers don't tell you, but a good doctor will... "A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name." So you might be under dosed or over dosed with Generics.

    • (Score: 4, Informative) by Anonymous Coward on Sunday May 20 2018, @04:58AM (2 children)

      by Anonymous Coward on Sunday May 20 2018, @04:58AM (#681778)

      That is actually a common misconception. The bounds of the 90% confidence interval of bioequivalence must be within those two limits. This does not mean that the actual drug concentration will actually be anywhere near those limits. The real difference is (usually) in the secondary effects of inactive ingredients and manufacture processes affecting the amount of time it takes to become bioavailable (the AUC) and the exact duration of said bioavailability. The different inactive ingredients and processes can also cause people to have different side-effects and contraindications for the generic.

      • (Score: 2) by arslan on Sunday May 20 2018, @11:06PM (1 child)

        by arslan (3462) on Sunday May 20 2018, @11:06PM (#681983)

        So what does all that mean to the lay-men? Here in oz, we're told, by the pharmacist at least, that generics and branded drugs have no difference apart from price..

        • (Score: 0) by Anonymous Coward on Monday May 21 2018, @01:34AM

          by Anonymous Coward on Monday May 21 2018, @01:34AM (#682012)

          First I want to clarify something. Latuda and amitryptiline are two different drugs. What MDC is talking about is not a difference of generic vs branded effectiveness.

          As for your question, when it comes to treating your condition, there is no real difference between generics and branded. Generics are just as safe and effective as branded drugs in every real sense. The difference comes in two places. The first is when the drug reaches dosing level in your blood, which can vary depending on the exact formulation and cannot be more than a few percentage points from the branded drug. For standard ingested drugs, the difference is literally seconds. However, that can cause people to have placebo reactions that magnify the actual difference. The second is side effects. Generics can have different side effects from their branded counterparts because the INACTIVE ingredients can be different. Usually they just use cheaper fillers (AKA bulking agents) but other excipients can be changed as well (as long as it doesn't affect the AUC/timing too much). Again, even slight changes in side effects can be magnified by the placebo effect, but if you check the inserts, they are usually minor (think slight indigestion). Really, the only time you need to be extra careful is when you switch between drugs, e.g. branded to generic, generic to generic, or generic to branded.

          A good video on the subject is here: https://www.youtube.com/watch?v=vqXrfzWgDkE [youtube.com]