Write You - News and Society

Last year’s mid-term elections did more than shift power to the democrats on a federal level. On the state level, including in New York State, democrats assumed control of a number of governorships as well. Eliot Spitzer, who ha

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

s long stood against corporate and political corruption, handily won New York’s top legislative position. As with most of those who ran successful campaigns, he won largely based on a reform platform, with the promise that “business as usual” in

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

Examples of combination products may in

Albany would be a thing of the past. One of the reforms Spitzer, along with running mate David Paterson and Attorney General Andrew Cuomo, said he would vigorously pursue is reform of our poorly conceived and co

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

nsequentially disastrous state drug laws.

Enacted in 1973 under then New York State Governor Nelson Rockefeller, the drug laws that bear his name were supposed to remove the most egregious offenders, kingpins, from the streets. Thirty years late

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

, the Rockefeller drug laws have been universally declared a resounding failure in this regard. The result: today most of the people incarcerated in New York for drug offenses are low-level, nonviolent offenders. And drugs? Well, they’re cheaper

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

Combination pro

nd more available now than they were 30 years ago. Nevertheless, variations of the Rockefeller drug laws have spread across the nation like an airborne virus.

Due in part to draconian policies like the Rockefeller Drug Laws, the U.S. now holds

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

the unenviable position of incarcerating more people than any other nation on the planet. Indeed, we have just 5% of the world’s population but 25% of the world’s prison population. Half a million of the 2.2 million people sitting in a prison c

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

ll right now are in for low-level, nonviolent drug offenses. There are fewer people in prison for all crimes in Western Europe (with a much larger population). As New York’s new governor reviews these laws, he should weigh these facts along wit

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

one more: in his state, 92% of the people serving time for drug offenses are African-American or Latino. This is the case even though rates of drug use are roughly the same across racial lines.

Consider the case of Ashley O’Donoghue, now servi

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

ng a sentence of 7 to 21 years in a New York State prison. In the fall of 2003, Ashley, who is African-American, was 20-years-old. For reasons his mother Cheri still does not understand, he began to sell drugs. Among his regular customers were

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

wo young white men named Peter and Preston. They would buy from Ashley and in turn re-sell the drugs on their Hamilton College campus. And then one day, Peter and Preston were busted by local police. They identified Ashley as the primary sourc

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

Following aspects would a

and the cops convinced them to order a whopping 70 grams of cocaine from him.

Never before had Ashley moved such a large quantity before, but at their request—really law enforcement’s request, he supplied the drugs. Upon his arrival at the camp

dd to the challenges in developing combination products:

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

us by train, Ashley was promptly arrested. Normally, with 70 grams on him, a life sentence would have been automatically triggered. In the end, Ashley didn’t get a life sentence, but he hardly got the break Peter and Preston got. Both informan

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

s received probation, while Ashley, out of fear of getting a life sentence, pleaded out to a B-class felony, under which the sentencing guidelines do not allow for a life sentence. But, because he pleaded guilty, he also lost the right to appeal

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

his case.

This is a common story, the story of most of the people sitting in New York prisons for drug offenses. They are not kingpins, never were kingpins, and their long incarceration periods do nothing to reduce drug use and abuse. Ashley’s

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

mother has acknowledged that her son must take responsibility for his wrongdoing, but to be placed under the control of corrections for two decades? That’s excessive—not to mention expensive. It winds up playing out along race lines and, to par

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

Professional from academic institutions, pharmaceutical industries, health care indust

phrase Rev. Jesse Jackson, to have a workable system of law and order, there must be one yardstick for justice. The Rockefeller Drug Laws, aside from failing to meet their stated goal of removing kingpins from our neighborhoods,

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

functions as a two-tiered system: one white, one for communities of color. It functions with two yardsticks. And that’s wrong.

In December of 2004, the first reforms to Rockefeller were made. But by far the largest number of people whose lives

.

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

could be improved by these reforms, continue to sit in prison absorbing scarce taxpayer dollars while, in the meantime, drug use and abuse remains fixed or rising. Spitzer and his team promised to make the drug laws in New York just and reasone

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

Companies that provide selfless information through particip

. I would urge them to set a new trend in what drug policy should look like and I urge them to do it sooner rather than later.

Copyright www.BlackandBrownNews.com 2007

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

Tags

Links

Write You - America's Longest and Deadliest Conflict: The War on Drugs and Communities of Color

Related Articles: