Answers - Legal

DWAI, or Driving While Ability Impaired, is a traffic violation in New York State and is covered by Section 1192(1) of the Vehicle and Traffic Law. It is a

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

lower level offenset isn't completely accurate. There are two DWI charges. Section 1192(2) is a DWI charge for havin than DWI (Driving While Intoxicated).

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

Examples of combination products may in

The easiest way to explain the difference between DWAI and DWI is by thinking about blood-alcohol content. In New York, DWI is typically charged against someone whose BAC is measur

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

ed at 0.08 or above. If the BAC is measured between 0.05, 0.06, or 0.07, the defendant is usually charged with DWAI. While this is easier, ig a BAC of over 0.08. This is fairly str

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

aightforward. If a jury believes your BAC is 0.08 or above, then you are guilty.

Section 1192(3) is what's known as "Common Law DWI." For common law DWI, the prosecutor must persu

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

Combination pro

ade a jury that you were intoxicated. This is a fuzzy concept and can be confusing to juries, and frankly to police, judges, prosecutors and even defense lawyers.

DWAI is more lik

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

e the common law DWI. The judge (there is no jury for DWAI because it is not a crime) must be persuaded that your ability to drive was impaired. The difference between intoxicat

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

ed and impaired is not well defined in the law, adding to the confusion mentioned above. However, the law does state that a BAC of 0.07 is sufficient on its own to prove

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

a charge of DWAI - though it is still possible to defeat the charge on a 0.07. With a 0.06 or 0.05, the prosecutor must submit additional evidence beyond the BAC to show impairmen

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

t.

In most NY DUI cases, the prosecution will have a few different kinds of evidence. This includes the BAC, standardized field sobriety tests (SFSTs) and the officer's gen

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

eral observations. The SFSTs suffer from a glaring flaw when it comes to DWAI cases: They are supposed to be a test of whether someone's BAC is over 0.10. In a DWAI case, the defen

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

Following aspects would a

dant's BAC is almost always well below 0.10. So if the prosecution tries to prove impairment by saying that the defendant failed the SFSTs, a capable defense attorney can argue tha

dd to the challenges in developing combination products:

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

t the tests must have been done wrong, since the BAC was actually below 0.10.

An important difference between DWI and DWAI is the licensing consequences if you fight the charges.

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

In DWI cases where the BAC is over 0.08, the defendant's license will be suspended while the case is pending under the "Prompt Suspension Law." In DWAI cases, the defendant's licen

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

se is not suspended until and unless there is a conviction. For DWI defendants, the prompt suspension law can be very difficult and persuades many defendants (even the innocent) to

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

take a deal. This pressure does not affect DWAI defendants, so it's easier for the defendant to fight the charges.

Another key detail involves plea bargaining. With most DWI case

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, the prosecution will offer a deal where the defendant would plead guilty to a lesser offense - often this means a reduction from DWI to DWAI. But with DWAI cases, there is gener

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

ally no lesser DUI offense. DWI laws in New York make it difficult for prosecutors to reduce a DUI charge to something that is not a DUI charge. Because of this, the typical offer

.

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

in a DWAI case is for the defendant to plead guilty to the charge. In other words, the plea bargain is no bargain. Other than attorney fees, a DWAI defendant has essentially nothin

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

Companies that provide selfless information through particip

g to lose by fighting the case.

We generally encourage our DUI clients to fight the charges, but the argument for this is strongest with DWAI cases, for the reasons detailed above

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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