IOM Suggests Other Alternatives To The Word "Counterfeit" re: Drugs

FDA Law Blog: Don’t Call It a Counterfeit, and Other Recommendations from the IOM Report on Falsified and Substandard Drugs:

"IOM recommended excluding the use of the term “counterfeit.”  There is disagreement in the international regulatory community as to whether “counterfeit” refers broadly to something that is “not what it claims to be,” or whether the narrower, legal definition, which focuses on trademark infringement, is applicable.  The IOM report forgoes the use of the term “counterfeit,” and instead encourages the use of the terms “substandard,” “falsified,” and “unregistered.”  “Substandard” drugs are “those that do not meet the specifications given in the accepted pharmacopeia or in the manufacturer’s dossier.” "

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FDA Should Revamp 510(k) Medical Device Clearance Process

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Updated November 4, 2022

Some of the links broke.

You can still read about the same topic here:

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years - NAP.edu

---  the original post follows below  ---

The LA Times reports, FDA is urged to revamp its review process for medical devices.

In a nutshell, the Institute of Medicine (IOM), an arm of the National Academy of Sciences (NAS), recommended that the system be abolished and new procedures established, IOM - Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.

Webcast of the Institute of Medicine - Public Health Effectiveness of the FDA 510(k) Clearance Process - Public Briefing (July 29, 2011)

Free Tips On Preparing For An FDA Inspection

Here's a good article from Bruce McDuffee, Tips on Preparing for an FDA Inspection - Are you following current good manufacturing practices?

References he mentions:
FDA form 482
Investigations Operations Manual (IOM)

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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FDA Explores How To Reduce Sodium Levels In The Food Supply

Today’s average sodium intake is several times what the body requires and its long-term effect on our health is very serious. Hypertension, or high blood pressure, affects one in three U.S. adults – nearly 75 million people aged 20 or older. An additional 50 million adults suffer from pre-hypertension. High blood pressure can increase the risk for heart attacks, strokes, heart failure, and kidney failure. Too much sodium in the daily diet is a major contributor to high blood pressure.

A new report from the Institute of Medicine (IOM) concludes that national action is imperative to reduce the sodium content of foods if we are to make significant progress toward reducing the risk of hypertension and major cardiovascular events for Americans.

The FDA will more thoroughly review the recommendations of the IOM report and build plans for how the FDA can continue to work with other federal agencies, public health and consumer groups, and the food industry to support the reduction of sodium levels in the food supply. The Department of Health and Human Services (DHHS) will be establishing an interagency working group on sodium at the Department that will review options and next steps.

I'm pleased to see these efforts. In our household, we don't add salt, and do our best to avoid processed foods, and foods containing way too much sodium salt.

Reference:  FDA Issues Statement on IOM Sodium Report
Consumer Information:  Lowering Salt in Your Diet

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FDA 483 Inspectional Observations - learn from these examples

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Here's a small collection of 483s (FDA Form 483 Inspectional Observations). If you've never seen one before, here's your chance. Take advantage of these to learn and share, so that you can avoid getting your own 483s. You can view these on the FDA's website, in the FDA Office of Regulatory Affairs (ORA) Electronic Reading Room. They display copies of ORA records. ORA makes these records publicly available either (1) proactively at their discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information.

According to GMP Trends Inc., "an FDA 483 is a form used by an FDA investigator following an inspection of your plant. It lists deficiencies in your quality system and potential non-compliance issues with GMP's. These observations are based on the investigators interpretation of the GMP regulations as they apply to your specific situation. During the investigator's closing meeting with management, you may be given a Form 483." You can learn more about the FDA's thinking on 483s by reading this section from one of their manuals, FDA Investigations Manual - Reports of Observations.

These 483s can do several things for you. They'll:

1. Get you more familiar with what a 483 is all about
2. Give you the willies so you'll never want to earn your own 483s
3. Provide examples that you can incorporate into your GMP training efforts

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