FDA Publishes Paper on cGMPs (Current Good Manufacturing Practices)

The Food and Drug Administration (FDA) just released this paper, Facts About Current Good Manufacturing Practices (cGMPs). They've published it because of the recent rash of regulatory actions they've taken against drug manufacturers for not following cGMPs. They say:

Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs. This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.

Knowing about and following cGMPs is critical for drug and supplement manufacturers. As a consumer it's important for me to know that there's oversight. Cheers to compliant and ethical manufacturers. 

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Global Outsourcing - Clinical Drug Trials - Hot Debate

Global outsourcing continues, and fuels some interesting debate, as evidenced by this recent New England Journal of Medicine (NEJM) article, "Ethical and Scientific Implications of the Globalization of Clinical Research." Of current interest, one of the author's name, Robert Califf, comes up as a candidate to lead the FDA. In CenterWatch's Clinicial Trials Today post, "Duke, NEJM Study Renews Debate on Global Outsourcing, they say "the NEJM study findings support common criticisms that trial participants in developing countries are often less informed and unduly influenced by the promise of money or medical care in return for participating in a study. While critics of clinical research in emerging areas (comprising 16% of total global clinical trials) can deride the informed consent process there, the West is no stranger to these problems." 

Related Posts: FDA Draft Guidance - Drug Supply Chain and SNIs FDA - Global Drug Supply Chain Needs Better Oversight Prescription Drug Reimportation and Safety - Both Presidential Candidates Support It 

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Flip Of A Coin Chance Your Doctor Gave You A Placebo (video)

 A recent report says that doctors prescribe placebos regularly. Watch this MSNBC News video for the quick story, "Half of U.S. doctors often use placebos." I have mixed feelings about this. The majority of physicians didn't tell their patients about it, and thought that the practice was ethical. This is food for thought. Are we weaker vessels these days? Are there other "ethical" practices going on? 

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Merck - Pharma Gone Bad

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Updated September 27, 2016

The link in the original post finally broke.

You might also be interested in the following in-depth analysis of the same marketing project mentioned below:
When clinical trials are designed by the marketing department

- -  original post follows below  - -

This is all too sad. I suspect this is just the tip of the pharma iceberg. This is a prime example of ethical pharma gone bad. What I find the most fascinating is the internal company struggle between marketing versus bona-fide clinical trial staff. Read the full story in this LA Times news article, "Drug maker Merck's marketing project passed off as research, physicians say."

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