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Screen Actors Guild and Screen Actors Guild Pension and Health Plans have been implicated in disclosing protected health information pertaining to Producer/Director BJ

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

Davis, Screenwriter Julia Davis, their relatives and dependents to the Department of Homeland Security. Under the guise of protecting homeland security, Internal Affair

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

Examples of combination products may in

s Agents of the Bureau of Immigration and Customs Enforcement (ICE), Jeffrey J. Deal and Herbert P. Kaufer have requested and obtained medical, insurance and identifica

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

tion information pertaining to BJ and Julia Davis and their family members, whereby SAG/SAG PHP disclosed to Kaufer and Deal medical information pertaining to a total o

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

f eleven (11) persons.

Julia Davis is a former Customs and Border Protection (CBP) Officer, who made serious whistleblowing disclosures involving national security. Ag

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

Combination pro

ents Kaufer and Deal have been instrumental in the series of unprecedented actions by the Department of Homeland Security, designed to discredit Julia Davis in an attem

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

pt to invalidate her terrorism-related protected disclosures, as reflected in the recently published book “Unsafe At Any Altitude” by Pulitzer Prize nominated investiga

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

tive journalists Joe and Susan Trento.

The disclosure of highly private medical and insurance records by the Screen Actors Guild is the latest in the already long list

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

of unconstitutional actions against BJ and Julia Davis by the Department of Homeland Security. In 2005, ICE and CBP misused government’s anti-terrorism funding to cond

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

uct a Blackhawk helicopter raid of the Davis’ residence, complete with twenty seven (27) Special Response Team (SRT) Agents armed with assault weapons, after subjecting

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

BJ and Julia Davis to two years of warrantless surveillance, conducting warrantless searches and falsely declaring Julia Davis to be a “domestic terrorist” and a “murde

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

Following aspects would a

rer”. The DHS was instrumental in organizing two malicious prosecutions and two false imprisonments of BJ and Julia Davis, although all charges against them were subseq

dd to the challenges in developing combination products:

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

uently dismissed, BJ and Julia Davis were declared factually innocent, their arrest records were ordered sealed and destroyed and the government was ordered to return p

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

roceeds of both warrantless searches. Julia Davis won a lawsuit against the Department of Homeland Security, which the agency is still refusing to honor.

Producer/Dire

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

ctor BJ Davis is a thirty year signatory member with the Screen Actors Guild. In addition to releasing protected medical records to the DHS, SAG unlawfully released pay

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

roll, tax, medical, insurance and other information pertaining to BJ and Julia Davis to a group of actors formerly employed by Producer/Director BJ Davis in his latest

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

Professional from academic institutions, pharmaceutical industries, health care indust

award-winning film.

These and other related events are currently being investigated by the Citizens Committee for Constitutional Protection (CCCP), with a recent reque

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

st for an official congressional inquiry. In an official statement, CCCP Chairman B. Harris stated: “There is a growing concern amongst American citizens as to the Law

.

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

enforcement officials’ misuse of the tools designed for fighting terrorism that are instead being utilized to compromise the constitutional rights and violate the right

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

Companies that provide selfless information through particip

to privacy of all Americans”.

"Those who would give up essential liberty to purchase a little temporary safety, deserve neither liberty nor safety". Benjamin Franklin

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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Answers - Screen Actors Guild Aids Department Of Homeland Security In Patriot Act Violations

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