ABOLISH THE FDA!!!!!!!!!!

[Guest guest]

The time has long since come for the Congress to abolish the U.S.

Food and Drug Administration, also known as the FDA. Contrary to the

baloney put out on the various pages of its web site, which would

lead the unwary taxpayer into thinking that the FDA is actually

protecting him or her from some hazard, the FDA has outlived any

usefulness its partisans and bureaucrats have claimed for it. Getting

rid of this bureaucratic dinosaur would save taxpayers nearly $1.7

billion (the proposed fiscal year 2004 budget), lead to reductions in

the prices of food and drugs paid by consumers, reduce lawsuits over

product liability, and reduce the number of lives lost and lives

shortened due to a lack of drugs and medical devices.

 

 

 

What the FDA claims to do

 

With a history that dates back to 1848 when Congress required the

U.S. Customs service to prevent adulterated drugs from entering the

United States, Congress has expanded the FDA's regulatory authority

over food and drugs over the years, all in the name of protecting

consumers from any risks associated with food, drink, or drug use.

Major milestones (or millstones, for taxpayers and consumers) include

the Food and Drugs Act and Meat Inspection Act, both of 1906, which

gave the FDA's predecessor agency power to enforce prohibitions on

the interstate commerce of misbranded or adulterated food, drinks,

and drugs.

 

 

 

While many of the food-related functions have been transferred to the

Agriculture Department, the FDA retains considerable authority in

this area, notably in dictating food-labeling standards and in

dictating the types of claims that can be made by manufacturers of

vitamins and mineral supplements.

 

 

 

As far as prescription drugs go, the FDA has been given additional

authority over the years. Notably, in 1962, after the sleeping pill

thalidomide was found to have caused birth defects in children born

in Western Europe, the Congress passed and John F. Kennedy signed

into law amendments to federal drug laws that required pharmaceutical

manufacturers to prove to the FDA the effectiveness of their products

before marketing them in the United States. Despite the apparent

Congressional intent of reducing the risk of using pharmaceuticals to

zero, unsurprisingly, the FDA has failed to do so. Instead, FDA began

the process of dictating standards for clinical drug trials and tests

and conducting a lengthy approval process that a manufacturer needed

to pass before bringing a new or modified drug to market.

 

 

 

Beginning in 1976, the FDA was given authority to apply a

similar " drug-style " approval process to all medical instruments and

medical test equipment.

 

 

 

The FDA has failed

 

This attempt by the government to insure consumers against the risk

of using drugs and medical devices has flopped on numerous occasions.

First of all, FDA regulations have often prevented U.S. consumers

from gaining access to new life-saving drugs. Examples of this

include major delays in the marketing of drugs used to treat cancer,

blood pressure, heart attacks, cholesterol, and strokes and delays in

marketing such high-tech items as cardiac pacemakers and in the use

of such techniques as balloon angioplasty for blocked coronary

arteries. For many years, the FDA would not allow the makers of

aspirin to claim on their product labels that aspirins thinned blood

and could thus save one from dying if taken during a heart attack.

The costs of FDA regulation of these markets has likely run into the

billions, possibly hundreds of billions, of dollars and is composed

of higher drug prices, fewer drugs, and more and lengthier illnesses

and earlier deaths.

 

 

 

In a call to the Bush Administration to merely reform the FDA, Henry

I. Miller, a fellow at the Hoover Institution and the Competitive

Enterprise Institute and a former FDA official, presented a

devastating critique of the FDA's regulatory process and procedures.

 

 

 

In his early 2001 editorial commentary, Dr. Miller stated that the

total time it takes to develop a new drug had doubled since the

1960's. And the costs to a manufacturer of bringing a single new drug

to market had risen to over $400 million, the highest cost in the

world. He further contended: " Costs are spiraling out of control

because the FDA meddles endlessly in clinical trials and keeps

raising the bar for approval. " Furthermore, he cited statistics that

showed the average number of clinical trials per average drug

increased from 30 in the early 1980's to 68 during the 1994–95 period

while the average number of patients in clinical trials for each drug

more than tripled! As expected, the average time required for

clinical trials for a new drug rose from 85 months in the first half

of the 1990's to 92 months in the last half of the 1990's.

 

 

 

And FDA approval of a drug has not been a guarantee that one was or

is using a safe drug. This latter contention was once again confirmed

in a Sunday, May 18, 2003 New York Times article about trial lawyers

focusing their efforts on launching mammoth lawsuits against

pharmaceutical manufacturers.

 

 

 

Life without the FDA

 

While many in the medical community like Dr. Miller believe that

sensible regulatory reform of the FDA should be the goal, instead the

FDA should be abolished.

 

 

 

Some – possibly many – are about to ask me: " Grichar, are you nuts?

What makes you, an economist and not a medical expert, think that the

drug companies and medical equipment manufacturers can be trusted to

regulate themselves! " To which I would respond, " They will not be

regulating themselves; the free market will regulate them. "

 

 

 

And here is how that could be done. In the absence of the FDA and

with trial lawyers looking for multi-billion dollar settlements in

lawsuits, pharmaceutical manufacturers and medical equipment

manufacturers have every incentive to be cautious in bringing out new

drugs and new medical devices. To this end, they would avail

themselves of independent private reviews of the results of clinical

trials and tests.

 

 

 

Medical experts – the same ones who testify on behalf of and against

manufacturers in various product liability lawsuits – would also

become involved as independent private review consultants. Most

likely, such experts would become affiliated with independent private

review institutes – similar in operational philosophy and techniques

to the famous Underwriters Laboratories – which would levy a charge

for a review of a new drug or medical device. Currently, the FDA

takes in about $250 million annually in fees (really taxes) it

charges manufacturers for seeking approval of a drug or medical

device. Manufacturers have thus demonstrated the willingness and

ability to pay for product reviews.

 

 

 

Insurers might also help fund such independent review boards or

institutes, as this would help lower their pay-outs in lawsuits. And

contrary to what some may think, medical experts would have every

incentive – mainly significant future earnings from participating in

drug and medical device and procedure reviews from the independent

review institutes – not to take bribes from manufacturers. (For a

great description and analysis of what of Underwriters Laboratories

does, see What Keeps Us Safe by Mark Thornton.)

 

 

 

If given a seal(s) of approval by accepted review institutes, the new

drug or device would be brought to market with that seal(s) publicly

displayed. Physicians, who often have to spend a fortune for

malpractice insurance coverage, would have the strongest incentive to

prescribe, in most cases, only those drugs or those devices that have

some seal(s) of approval. Their malpractice insurer would demand

that. However, physicians would be free to seek an exemption from

their insurer and the consumer in cases where application of a new,

but not-yet mass marketed or reviewed drug or device, might make the

difference between life and permanent disability or death.

 

 

 

Manufacturers would also be given an extra incentive to seek such

expert seals of approval for their new drug and medical device

products by their insurance companies, mainly in the form of lower

premiums for liability insurance if they get a seal(s) of approval.

Those not getting recognized approval would face higher liability

insurance premiums, possibly suspension of coverage for those

particular products, and likely lower demand for such products.

Getting a number of seals of approval, from these strictly

independent private review institutes, would further enhance the

marketability of a product and help insulate the manufacturer from

lawsuits.

 

 

 

Under the free market, insurers would also have the incentive to

offer consumers no-fault liability insurance for medical malpractice,

including the use of drugs and devices that have not gotten a major

seal or seals of approval by generally accepted review institutes.

And consumers would have a strong incentive to purchase such

insurance.

 

 

 

With such a private market system of insurance and risk reduction,

there would be fewer lawsuits and lower settlements. This would be

the case because of the extensive and competitive review of products,

seals of approval, and also review by various insurers. It would be

difficult for even the best trial lawyers to counter numerous expert

opinions rendered in such an unbiased manner prior to the sale of a

specific drug or medical device.

 

 

 

Dump the FDA!!!

 

To sum it up, a private market for the review of drugs and medical

devices could save the public billions of dollars. Not only would the

public (including drug and medical device manufacturers) save the

$1.7 billion it pays in taxes and fees to fund the FDA, but effective

drugs and devices would be brought to the market more rapidly and at

a lower cost. More lives would be saved, there would be fewer

permanently disabled, and illnesses would be shortened. Lower lawsuit

awards and settlements would more than likely compensate for any

extra costs of reviews.

 

 

 

Abolish the FDA and save lives and money!

 

 

 

May 19, 2003

 

Jim Grichar (aka Exx-Gman), formerly an economist with the federal

government, writes to " un-spin " the federal government's attempt to

con the public.