The FDA is on the Job.
Is that a Good Thing?

The FDA has come a long way and been around for a long time.

It's probably older that most of the people reading this.

If you were around in 1938, you saw the birth of the FDA with the passage of the Federal Food, Drug and Cosmetic Act. It has seen a lot of changes since then.

There was a really big step forward in April 1953 when the Department of health, Education and Welfare (HEW) was established during the Eisenhower administration.

Another big step was made twenty six years later in 1979, the Department of Education Organization Act became law and set up a separate Department of Education. So what does that have to do with food and drugs?

What it did was removed the "E" from the HEW leaving it with Health and Welfare. Apparently no one liked the "Welfare" part of the name so someone hit the "rename" button and came up with the Department of health and Human Services (HHS). It was also elevated to its own cabinet level position.

The activities belonging to the old Federal Food, Drug and Cosmetic Act were folded into the HHS and set up as a distinct agency that we know today as the Food and Drug Administration.

What we have here is a regulatory agency charged with the protection of our population from health hazards. That's a real comfort, otherwise people might be getting sick from tainted Chinese and Mexican food and prescription drugs with side effects and interactions.

Items under the purview of the FDA include all foods (except meat and poultry), prescription and non-prescription drugs, cosmetics, all animal drugs and feed, medical equipment, blood products, vaccines, tissues for transplantation and all devices that emit radiation, including microwave ovens.

The agency's responsibilities include truth in labeling for all food, supplements and medical products; safety and effectiveness testing and approval of all products designed to treat human conditions or diseases; and safety of 75% of the U.S. food supply including imported foods falling under FDA jurisdiction.

Regulation is one thing, enforcement is another. The agency has considerable enforcement options and is tenacious when choosing to exercise its options, often to the extreme.

A quick list of the FDA's available enforcement options include: seizure of products, detaining products to prevent their distribution while administrative action is underway, issuance of restraining orders against persons or companies, criminal misdemeanor or felony prosecutions (depending on intent) against persons committing a prohibited act, consent decrees and debarment.

Photo: FDA Five Star Hotel; You really don't want to check in here!

Penalties can include jail time from 1 to 10 years, large fines and penalties, and in some circumstances, disgorgement. Disgorgement (sounds gross!) is where the defendant is ordered by the court to give up all the profits and gains obtained through the criminal conduct.

Since this site is about health the natural way, the message is clear. if you happen to be a user, seller, distributor, or manufacturer of dietary supplements or other natural health products, don't mess with the FDA. Know what you can and can't say about your products but more about supplements later.

The FDA is the approving authority for all new drugs coming to market. Click here to see how the NDA process works.

Despite all the criticism we heap on the agency, they do a pretty decent job with what they have. The main functions can be lumped into protection, regulation, evaluation, approval and enforcement.

The FDA protects us with a long menu of safeguards that let us go about our daily routines without having to worry about the safety of all the products they regulate.

That's how it's supposed to work in theory anyway and all it costs the taxpayer is about two cents per day. At least according to the agency.

The FDA also protects Americans against public health hazards that range from debilitating to deadly.

It does this by ensuring the safety and in most cases the quality and effectiveness of a trillion dollars worth of products that constitute nearly one-fourth of the total consumer expenditures of U.S. citizens.

The goods whose standards are set by FDA's scientists are enforced by the agency's regulators.

New products that are designed to treat human conditions or diseases are evaluated for safety and effectiveness before they can be made available to consumers. Products can be as simple as a toothbrush or a non-prescription analgesic and as complex as a state-of-the-art excimer laser or the latest drug for cancer.

To be approved, these drugs and medical devices must meet rigorous standards, and they must continue meeting them while on the market.

FDA's inspectors and scientists ensure the safety and wholesomeness of 75 percent of all foods consumed in the U.S.

The agency is also responsible for the products' labeling, which must be truthful and not misleading. It finds and prosecutes purveyors of bogus medicines who prey on senior citizens.

A good example of the FDA's improvements in its efficiency is in the review of new drugs and biological agents. Before Congress passed the Prescription Drug User Fee Act of 1992, it took the FDA an average of 30 months to review a new medication before marketing.

After the act was implemented, the agency was able to hire additional reviewers and support staff that has helped reduce the median review time for drugs to 12 months.

Most breakthrough products are now reviewed in 6 months or less. Under the user fee program, the number of new drugs approved in a year has increased almost 40 percent, and their total development time has been shortened by almost one-fifth.

The safety of the U.S. food supply, under the protection of the FDA is funded under the Food Safety Initiative.

Because the agency must remain responsive to ever escalating public health challenges, its resource needs continue to grow in spite of the agency's management innovations. There are now serious gaps between what the agency needs to do and what it can do.

The agency needs to reinforce programs designed to assure the safety of products already on the market.

One example is the surveillance of foreign regulated products exported to the United States.

As a result of the expansion of global trade, which has increased the number of shipments of foreign-produced regulated products from about 1.5 million in 1992 to 6 million in 2000, FDA's investigators are now able to sample less than 1 percent of all foods offered for imports.

Now we get the picture!

Other urgent priorities of the agency include improvement of diagnostic tests for the nation's blood supply; enhancement of the quality and accuracy of clinical trial designs; and new methods to detect food contaminants to counter the emergence of previously unknown, virulent food borne pathogens.

The magnitude of FDA's public health responsibilities is huge and growing. Time will tell if they are up to the challenge.

The unpleasant truth is that increasing demands on the FDA detailed in the prior discussion make it more and more difficult to respond to the public’s expectations in spite of its growth in appropriations over the last 8 years.

We will address the questions and problems raised with prescription drugs in the pharmaceutical section.

We will get into some of the dietary supplement issues in the following paragraphs and more in the section on alternative and complementary medicine.

The truth is that if you are a user or distributor of dietary supplements or involved in any aspect of natural, complementary or alternative medicine (NCAM), the FDA has you in its sights.

There are numerous criticisms of the agency, some justified, some not. The most commonly heard complaints fall into one of the seven listed below.

The agency rejects or delays approval of useful drugs

There is some justification for this complaint. An organization will take whatever steps are necessary to protect itself. Milton Friedman, the economist opined that there is bias in the regulatory process that works against the approval of promising drugs.

The adverse effects of wrongfully banning a useful drug can never be known. On the other hand, the consequences of mistakenly approving a harmful drug will be highly publicized and therefore the FDA will take the action that will result in the least public condemnation; regardless of the health consequences.

Regulations contribute to the high cost of drugs

There is little justification for this complaint. There are conflicting studies on this issue. One published in 2003 estimated an average cost of approximately $800 million to bring a new drug to market. Another study three years later, estimated the cost to be anywhere from $500 million to $2 billion.

Photo: New York Federal Reserve gold vault: at current gold prices, about 23,000 of these gold bars would be needed to bring a new drug to market.

Yet another study by a consumer advocacy group using estimated the average cost for development to be under $200 million, about 29% of which is spent on required clinical trials.

Estimates are all over the map but one thig the authors of these studies have in common is that they dispute the claim that high drug development costs are responsible for high drug prices.

The argument being that at the time that drug prices are determined, the associated R&D spending for a drug is a sunk cost and thus does not enter into the determination of market price.

In contrast a Nobel prize winner has argued that required clinical trials for new drugs do contribute to high drug prices for consumers and that dropping these requirements would hasten the development of new drugs because they would be cheaper to bring to market.

Given that it does take hundreds of millions of dollars to bring a drug to market, it is nonsense to assume that the R&D cost has no effect on market price.

R&D is a budgeted cost, money for budgeted items either comes from profits or borrowing, so the development cost of a product is reflected in its market price and that of future products as well.

Yes, dropping the requirement for clinical trials would bring the drug to market faster and at a lower price but subsequent adverse effects would go through the roof. Do we really want more adverse drug effects?

The agency is slow in granting over-the-counter status

This is a valid criticism. WIthout a doubt, the prescription requirement causes consumers to spend time and money on unnecessary doctor's visits. Similar regulatory agencies in other major industrialized nations have been far ahead of the U.S. in switching drugs from prescription to over-the-counter status.

Restricts free speech in food and drug labeling and marketing

This is a valid criticism. The agency prohibits dietary supplement manufacturers from making unsupported claims of effectiveness on the labels of their products.

Manufacturers of supplements, which are considered foods for regulatory purposes, are allowed to make only limited "structure/function claims".

They are prohibited from claiming that the supplement can prevent, cure, or mitigate a disease or condition unless the supplement undergoes actual testing of its safety and efficacy. Such unsupported claims of effectiveness are considered false advertising.

The agency apparently hasn't woken up to the fact that good nutrition can and does heal a number of health conditions without the accompanying side effects and interactions of prescription drugs.

The heart of the question is "what is an unsupported claim?" They take the position that a personal testimony is an unsupported claim and thus false advertising. It is a real "gotcha".

Regulations say that only an FDA approved drug can cure, heal or mitigate a disease condition; thus if anyone says that a dietary supplement cured their health issue, then they must be promoting an illegal (unapproved) drug and therefore are breaking the law.

Go straight to jail, do not pass GO.

Representative Ron Paul (R-TX), introduced a bill on November 10, 2005 titled the "Health Freedom Protection Act" (H.R. 4284), which proposes to stop "the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements, and adopt the federal court’s suggested use of disclaimers as an alternative to censorship." Other critics, such as the Life Extension Foundation, claim that the prohibitions is a violation of the Constitutional right to free speech.

The agency is out to destroy the dietary supplement industry

This seems to be a valid criticism for the reasons stated above. The FDA has cut the legs out from under any type of effective marketing of dietary supplements and is aggressively going after both companies and individuals that verbally or in writing even hint that the supplement product can or will or has helped any health condition.

Approves unsafe drugs

This is a valid criticism. The agency has been very willing to overlook safety concerns in approving new drugs, and is slow to withdraw approved drugs once evidence shows them to be unsafe.

Self-interests, political pressures and economic interests seem to play a role in covering up adverse data.

A scientist in the Office of Drug Safety in CDER, testified to Congress that he was pressured by his supervisors not to go public about dangers of drugs like Vioxx. He claimed that a conflict of interest when the office responsible for post-approval monitoring of drug safety is controlled by the same organization which initially approved those same drugs as safe and effective.

According to a 2006 study, almost one-fifth of FDA scientists said they "have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a scientific document."

Pharmaceutical companies influence FDA decisions

this is a valid criticism. The prima facie evidence is that the FDA views the pharmaceutical industry as its client rather than an entity it is policing. The journal Nature reported in 2005 that 70% of FDA panels writing clinical guidelines on prescription drug usage contained at least one member with financial links to drug companies whose products were covered by those guidelines.

On March 21, 2007 they finally fixed the problem by announcing guidelines disqualifying experts from serving on advisory committees if they had received financial compensation from a drug company potentially affected by the committee's recommendations.

There have also been documented cases where approval of foreign drug applications have been withheld until the competing U.S. equivalent drug had been brought to market.

It would be a good investigative report to see how many former agency employees are now working in high paying jobs with pharmaceutical companies for whom they once had oversight responsibility. I suspect someone has already done such a study...I'm such it would make good reading.

I never thought I would ever write this, but there is one thing that Bill Clinton did right. On October 25, 1994 President Clinton signed into law, The Dietary Supplement and Health Education Act of 1994 (DSHEA).

Click here to read how DSHEA changed the regulatory authority of the Food and Drug Administration over dietary supplements.

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