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FDA- 101 - What Does FDA Approval Mean? (Part One)

Posted by Jane Akre
Monday, October 06, 2008 3:07 PM EST
Category: Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Federal Pre-emption, Preemptin, Defective Drugs, Drug Products, Food Safety, Foodborne Illness, Medical Devices, Diana Levine


The FDA has a limited reach over food and drugs, despite its image. 





“Low sodium,” “Natural,”  “FDA approved.”  

What do those terms mean?  In the case of sodium, the content can be easily measured. But “natural” could mean anything from nature, such as botulism.  It turns out “FDA approved” might hold little meaning as well.

The bulk of verification to the FDA for efficacy and safety is in the hands of the manufacturers.  Most people are surprised to find that the FDA does not test drugs. Instead the agency relies on the drug maker to submit studies that ensure efficacy and safety.

For novel foods such as those developed through genetic engineering such as corn or soy, the FDA relies on the manufacturers for assurances of safety. 

Since new novel foods are “Generally Recognized As Safe”(GRAS) because they resemble conventional produce, any consultation with government is purely voluntary.

Critics charge that the FDA does not have enough funding to adequately do the job of overseeing the nation’s food, drugs and medical devices.  At a time when food imports are increasing about 15 percent a year, the budget has not expanded to meet the need.

A 2006 Institute of Medicine report, The Future of Drug Safety, found that the Center for Drug Evaluation and Research staff, “are a dedicated and talented group of public servants who currently lack the organization and resources to address all of the challenges before them.”

In a recent court brief, former and current editors and authors of The New England Journal of Medicine (NEJM) said that companies such as Merck, Wyeth and Bayer Healthcare withheld important information from the FDA regarding the safety of certain drugs, costing many lives. 

Without this information, the FDA cannot adequately regulate, and consumers cannot know a drug’s danger, say former FDA regulators Dr. Donald Kennedy and Dr. David Kessler in another brief. 

In many cases the approval process has become the tail wagging the dog, as manufacturers maneuver the approval process. 

Published studies heralding the off-label use of a drug have driven sales, as have aggressive marketing campaigns, even though the drug has not been approved for that use.  Ghostwriters have been hired by pharmaceutical companies to downplay bad news about the risk of mortality. Only then have regulators stepped in to stop the practice.

Amid all of the bad public relations concerning tainted vegetables and drugs, the FDA spent $300,000 to hired a PR agency, that works with the pharmaceutical industry. Last week, FDA deputy commissioner John Dyer suspended the contract.

Congress gives the FDA the authority to regulate, issue health advisories, send out warning letters to drug makers, seize a defective product and prosecute through the Department of Justice.  Much of the agency legal action has focused on dietary supplements and drugs imported from Canada

Neurontin is the only drug that recently faced criminal charges.

Despite its failures, passing FDA scrutiny is increasingly being used as a tool to preempt or prohibit consumers from taking an injury to trial (See  Levine case ) in state courts.

The FDA is detailing what it does approve on its web site so consumers can know how to decipher an “FDA approved” promise.


Companies and Facilities

The FDA does not approve companies, including health care facilities, laboratories, or manufacturers. In terms of facilities, mammography centers must be FDA certified indicating they have met certain standards.

The FDA does inspect product manufacturers. However, in China, scandals with heparin and milk have shown that the FDA did not have the resources to inspect overseas producers, though foreign food, drug and device facilities are required to register with the FDA. 



The FDA regulates almost every facet of prescription drugs from testing, to manufacturing, labeling as well as efficacy and safety.  Companies wanting approval for a new drug submit laboratory, animal and human clinical tests for approval.  The manufacturer must prove to the FDA that the product is safe and effective.   

After a new drug approval, the company must report every adverse drug reaction, though reporting is voluntary.  Additional clinical trials may be required as a condition of approval.


Medical Devices

Not all medical devices carry the same risk. The FDA classifies devices according to risk and only the highest-risk devices, such as a mechanical heart value or a pump that is used for infusion and is implanted in the chest, require FDA approval.   Lower risk medical devices such as bandages have been exempted from premarket review.

A medical device that poses a moderate risk such as catheters or dialysis equipment can be cleared by FDA regulators if they are substantially equivalent to a device already on the market. Again, the maker needs to convince the FDA of safety and effectiveness.   (See More in Part Two)  #


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