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what_fda_ratings_mean

What FDA ratings mean

Related Terms: lymphedema, immunocompromised, fda, fda drug ratings, medical equipment, infections, bacterial, fungal, clnical trials, evidence based, effectivenss ratings

Those of us with lymphedema are immunocompromised in the lymphademetous limbs, making us a highly at risk group for serious infections, both bacterial and fungal. As such, many many of us have been on extensive antibiotic therapy and often use medical supplements in our attempts to stay healthier and/or to fight infections. I thought, therefore, it might be important for us to understand what certain drug, or products ratings mean

We have all seen these ratings on various medicines, drugs, compounds and what not. But, what exactly do they mean?

My favorite is “FDA approved.” This could be many many things and drug manufacturers, medical equipment manufactures all throw this around to impress we the patients to trust them and buy their product.

Pat

Feb. 2, 2012

What does FDA approved mean?

The United States Food and Drug Administration (FDA) is the federal governmental agency charged with protecting the health and welfare of the American public through the regulation of food, drugs and medical devices, among other responsibilities. It is probably the most critical mission assigned to any of our federal governmental agencies and, as you can imagine, the FDA takes its oversight mission seriously. Its regulations are extremely stringent. Its inspections are thorough. Its penalties for non-compliance are damaging. But when you are talking about food, drugs and medical devices, you wouldn't want it any other way, would you? When we say that the test kit is FDA-Approved, it means that EVERY aspect or component of the test system, including any claim found on our kit boxes, has been scientifically proven to be valid, safe and effective.

This involves extensive clinical trials with hundreds of patients, backed up by voluminous documentation and verification of the clinical trail results. It also includes a thorough FDA inspection of the laboratory and facilities in addition to intense review of the validity of the computer system's hardware and software. It is against the law for any product or service to claim it is FDA-Approved when it isn't. And when a product isn't FDA-Approved it means that FDA hasn't been afforded the opportunity to review or pass judgment on any data or science connected to a specific product's claims.

Johns Hopkins Health explains it this way:

Approval by the U.S. Food and Drug Administration (FDA) means that clinical studies have proven a drug to be more helpful than harmful for specific diseases and conditions. But FDA approval does not guarantee that a drug is absolutely safe and universally effective.

Instead, it signifies that a drug is sufficiently safe and effective when used within the limits defined by its testing for indications, side effects, and contraindications. Even so, the demonstrated risks and benefits may change once a drug is tested in a larger and more diverse group of patients. (1)

Another consumer site reports this:

It's approved by the FDA, so it's the best medication for me, right?

Actually, approval by the Food and Drug Administration does not confirm that a drug is the most effective or the safest drug you can take for your illness. It tells you that it has been shown to be effective for its proposed use and that its benefits outweigh its risks. It also tells you that the manufacturer of the drug spent millions to be granted FDA approval because it expects to earn millions more from the sales of its product. FDA approval does not signify that it is any more effective, or safer or has fewer side effects than other, often less expensive alternatives. (2)

(1) Johns Hopkins Health Alerts

(2) MOOD Letter

FDA approval medical device

When FDA review is needed prior to marketing a medical device, FDA will either

1. “clear” the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or

2. “approve” the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.

Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.

To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is “substantially equivalent” to a device that is already legally marketed for the same use.

To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.

About FDA

Effectiveness of the ratings. The Effectiveness ratings in the Database are EVIDENCE-BASED. The FDA doesn't regulate herbs and dietary supplements like prescription drugs. Herbs and dietary supplements can be sold without ANY proof of effectiveness or safety. Our team evaluates all of the medical literature to give you Effectiveness ratings based on the best scientific evidence. We rate each product for a particular use or condition. If a product is used to treat more than one condition, you may find different effectiveness ratings for each use. Here are the ratings you will see…

Effective: This product has passed a rigorous scientific review (similar to and as rigorous as the review of drugs done by the FDA)… and found to be effective for a specific use.

Likely Effective: Reputable scientific references generally agree that the product is effective for a specific use … and at least two scientifically rigorous studies (involving at least several hundred patients) found the product to be likely effective… and the studies are published in reputable scientific journals.

Possibly Effective: Reputable scientific references suggest that the product might work for a specific use … and at least one study (in humans) found that the product might be effective.

Possibly Ineffective: Reputable scientific references suggest that the product might not work for a specific use… and at least one study (in humans) found that the product might not be effective.

Likely Ineffective: Reputable scientific references generally agree that the product is not effective for a specific use… and at least two scientifically rigorous studies found the product likely to be ineffective… and the studies are published in reputable scientific journals.

Ineffective:

Most reputable scientific references agree that the product is not effective for a specific use… and no reliable human studies show the product to be effective.

Insufficient Evidence: If we know claims are being made about a product but there is no scientific info available about the effectiveness or ineffectiveness of the product, we'll let you know.

RXList

Reporting side effects

FDA Report

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what_fda_ratings_mean.txt · Last modified: 2013/01/05 07:47 by Pat O'Connor