(PatriotWise.com) — The Food and Drug Administration (FDA) has been given the right to prohibit medical treatments it has not expressly authorized. The new power was contained within the Omnibus spending bill that was rushed through Congress before Christmas. Some doctors have now expressed alarm that they may not be able to use approved treatments in a way they feel is best for patients. For example, some drugs may be approved to treat a particular illness, but doctors know they can also use the same drug to treat other illnesses and use it for those purposes instead. This is known as “off-label” use and may no longer be permitted, meaning that a government agency has the power to effectively overrule doctors.
On its website, the FDA makes patients aware of “off-label” treatments and states, “If you and your healthcare provider decide to use an approved drug for an unapproved use to treat your disease or medical condition, remember that FDA has not determined that the drug is safe and effective for the unapproved use.”
The FDA had reportedly requested the new powers following a court case in 2020 that did not produce its desired result. A ruling by the US Circuit Court of Appeals for the District of Columbia held that the FDA had the ability to ban a medical device under Section 36 of the Federal Food, Drug, and Cosmetic Act (FDCA) if it poses “an unreasonable and substantial risk of illness or injury.” However, it would not allow the government agency to prohibit medical practitioners from using the treatment intended for one illness to treat another.
The $1.7 trillion Omnibus spending bill was passed in the early hours of the morning on December 21st last year. It consisted of 4,155 pages of legislation. More than half of the House of Representatives cast their vote by proxy and some said they did not have time to read what was contained in the bill.
Copyright 2023, PatriotWise.com
