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It was formed by a group of inmates who previously served time in the California prison system, the

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

Texas Syndicate, with a confirmed membership of 241, is the oldest and the second largest inmate gan

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

Examples of combination products may in

in the Texas Department of Corrections. The Mexican Mafia or MEXIKANEMI less than 2 years in existe

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

nce, has a confirmed membership of 304 and is the largest inmate gang in Texas. Hierarchically, both

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

gangs are organized along pare-military lines. The Texas Syndicate is headed by a president and vice

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

Combination pro

president who are elected by the entire membership. On the unit level, the Texas Syndicate is contr

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

lled by a chairman who oversees the vice chairman, captain, lieutenant, sergeant of arms, and soldie

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

rs.

With the exception of the president, vice president, chairman, and vice chairman, all other low

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

r ranking positions are filled by individuals of outstanding criminal activity performance records f

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

or the gang. In order to avoid intra-gang conflict, a ranking member, other than the president and v

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

ce president, is automatically reverted to the status of a soldier when he is reassigned to a differ

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

Following aspects would a

nt unit by prison officials.

All ranking positions in the Mexican Mafia organization, excluding the

dd to the challenges in developing combination products:

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

sergeants, are elected based on the individuals' leadership ability to deal harmoniously with peopl

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

. There is no system designed to avoid intra-gang conflict. Leaders keep their ranks and titles upon

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

reassignment to a different unit by prison officials.

Regardless of ranks, both inmate gangs requi

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

e their members to abide by a strict code of conduct known as the "Constitution." For members of the

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

Professional from academic institutions, pharmaceutical industries, health care indust

Texas Syndicate, the constitution consists of eight rules: be a Texan; once a member, always a memb

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

r; the Texas Syndicate comes before anyone and anything; right or wrong, the Texas Syndicate is righ

.

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

t at all times; all members will wear the Texas Syndicate tattoo; never let a member down; all membe

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

Companies that provide selfless information through particip

s will respect each other; keep all gang information within the group (Texas Syndicate Constitution)

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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