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Beverly Hills, CA. June 21, 2005 – A decision was reached in the complaint of discrimination filed by former Customs and Border Protection Officer Julia Davis against the Department of Homeland Security (EEOC No. 340-04-00317X). 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

Honorable Administrative Judge Daniel Leach presided in the hearing held in San Diego, CA earlier this year and has found that Julia Davis was subjected to sexual harassment by the Agency’s Senior Supervisor; that she both properly a

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

Examples of combination products may in

d timely used Agency procedures to complain about the harassment; and that the agency failed to undertake reasonable efforts to investigate and to remedy the unlawful conduct to which she was subjected.

Judge Leach ruled that the Ag

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

ncy failed to protect Davis from her Supervisor’s sexual harassment, stalking, sexual battery and offered no remedial action to correct the situation. Moreover, the Judge determined that the Agency failed to request an investigation

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

y the Office of Inspector General in contravention to the Agency’s own laws and regulations.

According to the Judge’s decision, Department of Homeland Security/ Bureau of Customs and Border Protection high ranking managers not only

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

Combination pro

failed to protect Davis from her Supervisor’s illegal conduct but also attempted to prevent Davis from obtaining a restraining order against Supervisor Kevin Crusilla. High level manager Orlando Chambers, with the knowledge of San Ys

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

dro, CA Deputy Port Director Sally Carrillo, used official agency stationery and submitted a written endorsement of the harasser’s moral characteristics in order to convince the Judge in the state proceedings not to restrain him from

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

harassing Davis.

In spite of such interference by high ranking Agency officials, the injunction prohibiting harassment was issued by the Superior Court in favor of Davis. The California Superior court found sufficient evidence on wh

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

ch to conclude that Davis had been victimized by the ongoing and egregious harassment of Agency Supervisor.

As stated in the ruling, eleven month after Davis reported sexual harassment, stalking and sexual battery to her superiors,

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 Office of Inspector General completed its investigation and concluded that Davis had been subjected to sexual harassment. The harasser refused to meet with the OIG Investigator, went AWOL and was allowed by the high ranking Agenc

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

officials Bruce Ward, Oscar Preciado and Adele Fasano to retire with impunity.

The Judge ruled that Davis was compelled to resign from her position in the face of ongoing harassment and the repeated failures by the Agency to take a

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

Following aspects would a

y action to investigate, much less to remedy the situation. To make matters worse, management officials intervened in Davis’s civil action in order to oppose the court order to enjoin the harasser’s illicit actions.

The Judge found

dd to the challenges in developing combination products:

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

he harasser’s inappropriate conduct and the Agency’s complicity so objectively offensive as to alter the conditions of Davis’ employment. The Judge ruled that given the nature and depth of Agency’s betrayal of Davis, no reasonable pe

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

rson could have continued working in such an employment environment.

Davis has a pending appeal before the Merit Systems Protection Board to be reinstated in her job. EEOC Judge Leach stated, “While complainant’s termination is not

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

efore me, I find that based on the record in the case, complainant has established not only that the Agency engaged in illegal conduct, but also that the conduct was intolerable to a reasonable person because it was especially humili

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

ting and included unnecessary harassment. Secondly, I find that complainant’s resignation was caused by, or in response to, the illegal treatment”.

US Senators Dianne Feinstein, Barbara Boxer, Congresswomen Susan Davis and Mary Bono

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

Professional from academic institutions, pharmaceutical industries, health care indust

are monitoring the events, pending future official inquiries. The Judge’s decision reads in part: “…in the course of the hearing it became apparent that the staff of the agency was unfamiliar with appropriate standards of conduct app

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

licable to workplaces comprised of males and females…I found that there exists at this facility a culture which trivializes and minimizes the appropriate status and position of females.”

Davis holds a Masters degree in Aviation and

.

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

pacecraft Engineering and fluently speaks multiple languages. Davis also worked as Academy Award winner Angelina Jolie’s stunt double in the feature film “Playing God” during her employment in the film industry, which preceded her fe

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

Companies that provide selfless information through particip

eral law enforcement position. Davis stated: “This ruling is a major cornerstone in protecting equal opportunity and civil rights of all female employees.”

For more information visit http://www.DepartmentofHomelandSecurityExposed.co

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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