Can one be compensated for vaccine injury even if the vaccine is administered “off label”? Let’s first look at what “off label” means.
In the United States new drugs are tested in clinical trials before they are approved for use in the general public. When the US Food and Drug Administration (FDA) is satisfied that the drug works and is safe, the FDA and the maker of the drug create the drug label.
This is not an actual label that sticks onto a bottle, but a report of very specific information about the drug. The FDA must approve this report, which is made available to all health professionals who prescribe or sell the drug. The drug label gives information about the drug, including the approved doses and how it’s to be given to treat the medical condition for which it was approved. When a drug is used in a way that is different from that described in the FDA-approved drug label, it is said to be an “off-label” use. This can mean that the drug is: used for a different disease or medical condition, given in a different way (such as by a different route), given in a different dose than in the approved label.
The off-label use of FDA-approved drugs is not regulated, but it is legal in the United States and many other countries. While it is legal for doctors to use drugs off label, it is not legal for drug companies to market their drugs for off-label uses. This has been a hot news topic recently, as drug companies have been fined because they promoted drugs for uses not approved by the FDA. Off-label marketing is very different from off-label use.
So, what are the rights of those who believe that they have been injured from medications, like vaccines? The Health Resources and Service Administration’s website states that on October 1, 1988, the National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program (VICP). The VICP was established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines. The VICP is a no-fault alternative to the traditional tort system for resolving vaccine injury claims that provides compensation to people found to be injured by certain vaccines. The U. S. Court of Federal Claims decides who will be paid.
But the question remains, is eligibility to receive compensation under the National Vaccine Injury Compensation Program (VICP) affected by whether a covered vaccine, such as Tdap, is administered “off-label” or against ACIP administration recommendations? The answer is no. Eligibility for the VICP is not affected by the standard of care in administration of a vaccine. In other words, an individual may file a petition and be eligible for compensation regardless of negligence of the administrator.
For an injury, you may be paid a reasonable amount for past and future non-reimbursable medical, custodial care, and rehabilitation costs, and related expenses, even if the vaccine was administered to you “off label.”
Therefore, if you were vaccinated and feel that your injury or condition came from the vaccination, even if it was “off label”, refer to the National Vaccine Injury Compensation Program and the Vaccine Injury Table. You may be qualified to file a claim and could also be eligible for compensation.
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