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Thus, the judge said, the vaccine was an "investigational" drug being forced on the troops for an unapproved purpose.
He ruled that the vaccine used in the Pentagon's mandatory program was "an investigational drug," being used for an unapproved purpose.
Previously, Judge Sullivan had agreed with plaintiffs, soldiers who remain anonymous, that this vaccine was in fact "investigational," and was being administered to troops, for an "unapproved purpose".
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The company paid $2.3 billion to settle claims that it had marketed numerous drugs for unapproved purposes.
But F.D.A. guidelines say drug companies and device makers may not promote their products for unapproved purposes or patient categories, like prescribing adult medicines for children.
Technically, the F.D.A. does not regulate the practice of medicine, so doctors are indeed able to use approved drugs and devices for unapproved purposes when they deem it appropriate.
In the past few years, the F.D.A. has accelerated its campaign against the use of H.G.H. for unapproved purposes, sending letters of warning to clinics and companies that promote the drug as an anti-aging treatment.
Administration of medication for unapproved purposes is not well defined or properly described in some reports.
But more data from animal tests are needed.Some researchers propose going "off-label" with the unapproved use of existing drugs for other purposes.
Many insurers, however, might refuse to cover an unapproved use.
Using a drug for an unapproved use can be risky.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com