Actual - Legal

How do CA courts deal with FST’s that are not performed in accordance with NHTSA?

The National Highway Traffic and Safety

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

Administration (NHTSA) has done extensive studies of field sobriety testing (FST’s) in order to determine the probability

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

of intoxication. Law enforcement agencies have utilized FST’s for many years to develop probable cause for arrest and a

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

s evidence to be used in the prosecution for drunk driving. However, not all FST’s have been scientifically determined to

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

be accurate reflectors of alcohol intoxication. NHTSA has determined that three FST’s are accurate indicators of alcohol

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

intoxication, when administered in a standardized manner. These tests are called Standardized Field Sobriety Tests (SFST

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

’s):

1. Horizontal Gaze Nystagmus (HGN). HGN is an eye test that is 77% accurate in reflecting a blood alcohol count (BA

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

C) above .10%. Nystagmus is an involuntary jerking of the eyes at a certain angle, off to the side.

2. Walk-and-Turn (WA

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

T). WAT is a walking test that is 68% accurate in reflecting a BAC above .10%.

3. One-Leg Stand (OLS). OLS is a test do

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ne in a stationary position that is 65% accurate in reflecting a BAC above .10%.

The HGN in combination with the WAT refl

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

cts an 80% accuracy rate in determining a BAC above .10%.

The WAT and the OLS are “divided attention” tests. Divided att

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ention tests require a subject to listen to and follow instructions while performing simple physical movements. Sober ind

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ividuals are supposed to perform these tests with no problem. Impaired individuals, however, have difficulty with tasks r

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

equiring their attention to be divided between simple mental and physical exercises.

As mentioned above, law enforcement

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

agencies utilize FST’s in addition to SFST’s. The SFST’s have an advantage in that they have scientific backing. However

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

, FST’s do not have such scientific data to support the conclusion that the drunk driving subject is intoxicated. Example

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

s of FST’s include: the Rhomberg Balancing Test, Finger to Nose, Alphabet Test, Count Down, and Hand Pat, among many othe

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

rs.

Even though the FST’s do not have scientific backing reflecting reliability, most courts will still admit the tests i

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

nto evidence. In California, courts allow all FST’s into evidence, but defense counsel can attack the weight of the evide

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

nce by challenging the reliability of the non-standardized tests. Other states only allow the actual SFST’s into evidence

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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