Where Are Your Psychiatric Meds Manfactured?

Think the United States Food & Drug Administration (the FDA) has your back and is keeping your psychiatric medications safe? Inspections & safety are two basic functions of the FDA, but what’s really been going on?

Let’s take a look.Both the American Scientist, an illustrated bimonthly magazine about science and technology & Miller-McCune an online magazine on current academic research addressing pressing social concerns, reported the following this week:

  • up to 40% of medical drugs are manufactured outside the US
  • the FDA visits only 11% of 3,765 (or 414) of foreign factories
  • it takes 2-5 years to follow up on citations on drug manufacturing plants that have safety complaints on file.
  • and there’s more

Patients in the United States receive prescriptions from their psychiatrist or general practitioner for drugs manufactured outside US borders. At best, they are minimally inspected. Is that OK with you?

The leading drug manufacturer is China, followed by India & Canada.

http://mmc-podcasts.s3.amazonaws.com/Miller-McCune-MedicineCabinet.pdf

Have an opinion about these facts?

Be proactive & make your voice heard: Talk to your mental health care provider and ask them if they know where the drugs they prescribe are manufactured. Ask them what their medical opinion is on this fact.*

If you don’t like what you hear, speak up!

Educate yourself, inform your family & friends, be aware.

Pdf retrieved 01.13.12.

*This blog is not a substitute for medical advise. Talk to your physician regarding your mental health care.

Creative Commons License
is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License.

Advertisements
Leave a comment

6 Comments

  1. Hi Jeanette,

    “…How can any regulatory agency oversee product when some are manufactured in other countries? There would need to be a large workforce to do the job, or perhaps those manufacturing plants need to be relocated in the United States to make oversight more manageable…”

    There is a great deal of international cooperation that happens. A number of Regulatory bodies, ie the European, Canadian, Australian (to name a few) all cooperate, share audit findings and adhere to essentially the same guidelines (as generally led and established by the FDA). I say essentially because I can’t state for a fact they are all identical, but cGMP guidelines are generally equivalent worldwide. Yes, there differences, but it’s much too big a scope for this humble person to either know all or explain all 🙂

    “Large workforce”? The US tax dollars at work decide just how big the workforce is…

    “those manufacturing plants need to be relocated in the US…”? That’s a nice idea, but perhaps a little idealistic 🙂 And not a good business model for a sound world economy.

    Check out the FDA website, it’s actually quite informative. Google “cGMP” as well for a sense of what the industry is legally bound to do. Warning though, it’s dry reading…

    Like

    Reply
  2. Hi Jeanette,

    Interesting read on where our drugs are manufactured. As an employee within the drug manufacturing business and outside of the US, I can tell you though, that international firms are audited consistently and regularly by the US FDA. Mandates within the companies I deal with are to assume they can be audited at any time by either their own domestic Regulatory Agency or the FDA and they operate their businesses accordingly. All consider (correctly) the FDA to be the most significant agency in the world for both industry enforcement and policy setting. The FDA is however, a government agency and funded by the US taxpayers. (I’ll leave that for those with political opinions to comment further on if they choose). The media assumes the FDA looks after everything everywhere and can simply swoop down, “fix everything” and throw offenders in jail. Unfortunately for all of us, it isn’t that easy.
    In my humble opinion, where the concern should be is the plants that manufacture the raw materials, ie the ingredients with which our medication is manufactured. Here is where you see the offshore manufacturing with significantly less monitoring and auditing by Regulatory Agencies that you speak of. Reference the heparin scare a few years back where a dangerous substitution for an active ingredient was being made and shipped to the US for drug manufacture. It’s my understanding that the FDA, although viewed to be “late to the party” probably because of budgetary reasons, did an excellent job of investigating and also then reviewing its own policies regarding the auditing of outside firms.
    Cheers.

    Like

    Reply
    • Hi there knees & toes:

      You stated: In my humble opinion, where the concern should be is the plants that manufacture the raw materials, ie the ingredients with which our medication is manufactured. This, I believe, was the crux of this article.

      I appreciate you coming and telling us about your experiences.

      How can the FDA regulate a drug that has components manufactured at another site? Seems to me that unless they specifically do, there is no oversight until the drug is through the manufacturing process, is that a correct assumption?

      Yes, the article says that outside firms are reviewed, but the shear volume of them makes only a small percentage of those factories subject to inspection.

      Do you have different insight on this? Please come back and share if you want. I’d love your insight as every article I link to or read is not something I totally agree with or, for that matter, believe as the full story. It takes people like you to tell the rest of the story.

      Best.

      Like

      Reply
      • Knees & Toes –

        I replied to your post but there was a barrage of comments so I may have deleted it by mistake. I don’t want to duplicate posts. Hold on! Thanks.

        Like

        Reply
    • Knees and Toes –

      Can’t find my response, so please forgive me if it turns up later…

      I’m not sure what it means to patients that the FDA is leading the world in oversight of product. Good to know, it seems we have a long way to go to insure that the ingredients in a drug are the right ones.

      How can any regulatory agency oversee product when some are manufactured in other countries? There would need to be a large workforce to do the job, or perhaps those manufacturing plants need to be relocated in the United States to make oversight more manageable.

      What do you think.

      Thanks again for your valuable insight.

      Like

      Reply

What do you think?

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s