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While calls for the resignation of Attorney General Alberto Gonzales over the firing of eight U.S. attorneys continue, both Gonzales and President Bush continue to hold their ground. While members of C

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

ongress on both sides of the aisle have criticized Gonzales over misleading statements concerning the firings, others have denounced the whole situation as yet another Washington political witch hunt.

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

Examples of combination products may in

However, it is not entirely clear to me exactly what Gonzales did wrong to make himself a target of these resignation demands. As in most cases, though, reasons exist both to support and oppose these d

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

mands.

First, it is rather clear that the AG should not resign merely because the firings were (at least in part) political in nature. Because Bush, like any president, can generally fire executive of

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

icials for any reason or no reason at all, Gonzales should not be an indirect scapegoat to be sacrificed by those opposing this well-established executive authority.

However, the manner in which Gonza

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

Combination pro

es has handled this congressional inquiry is perhaps a more appropriate basis for calling for his resignation. For example, Gonzales has led members of Congress and the public to believe that he had ei

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

her no role or a very minor role in the firings. Despite that representation, the media has reported that Gonzales was present at a meeting where his aides formulated a plan for the firings. Moreover,

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

Gonzales reportedly approved this plan. On its face, this revelation appears inconsistent with his previous representations.

Although Gonzales probably did not knowingly lie or misrepresent the extent

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

of his involvement, a serious question arises as to his credibility as the chief officer in the Department of Justice, a department where credibility is paramount to maintain the trust of the public. I

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

the public cannot trust the attorney general on matters as inconsequential as perfectly legal firings or attorneys, one wonders if he can be trusted on any matter. At the very least, Gonzales has eith

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

r a very bad memory or is simply too careless with his words to be trusted by Congress and the public.

The other possibility is that he simply has no respect for Congress and refused to take the time

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

Following aspects would a

o accurately check his schedule and other records before making these misleading statements. While Gonzales could plausibly argue that he merely meant that he was not aware of the actual reason for the

dd to the challenges in developing combination products:

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

firings, that excuse does not vitiate the sobering reality that he comes across as uncooperative and unreliable in the search for the whole truth.

One would be bold to insist that the attorney general

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

is cooperative and reliable as it pertains to congressional oversight. As they say in the professional-wrestling world, this man is a serious "heat magnet." He could have and likely should have accurat

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

ely and fully disclosed the extent of his involvement before making any statement. Gonzales is good at one thing - making a bad situation even worse.

On a side note, it is also puzzling that one compo

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

ent of the plan approved by the AG consisted of ways for dealing with any political fallout caused by the firings. Considering how badly DOJ has handled this controversy, it is manifestly clear that th

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

Professional from academic institutions, pharmaceutical industries, health care indust

t part of the plan was seriously neglected. Mark that as one more signal that Gonzales has a difficult time carrying out the plans of his department. At the very least, one has to wonder why there is n

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

clear documentation that details the reasons for the firings. Does a U.S. attorney not deserve just a little more respect than this?

In short, the real measuring stick for deciding whether Gonzales s

.

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

ould resign is his inability to effectively cooperate with congressional oversight. Mr. Attorney General, I will let others decide whether you should resign, but please do us all a favor and take some

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

Companies that provide selfless information through particip

asic classes on public relations. As it stands now, all you can do is turn a simple case of heartburn into a quadruple bypass. Even the Bush administration deserves more than this level of incompetence

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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