Medical Malpractice and Personal Injury Law Blog

Is the FDA Changing its Mind about the Promotion of Off-Label Drugs?

Posted by Charles Gilman | Apr 17, 2017 | 0 Comments

Before medications are placed on the market for distribution and sale, they must undergo a comprehensive and meticulous approval process. As a part of this process, pharmaceutical companies are required to submit explicit evidence that medications are safe for consumption and effective for its intended and prescribed use. As with most industries, there are incentivized agendas that may cause doctors and pharmaceuticals to stray from these crucial processes, which in turn, trade the safety and wellbeing of patients for financial gain.

The promotion and hasty prescribing of “off-label” medications has been an ongoing issue for years now. Off-label refers to the actions of prescribing or marketing available medications for an indication that has not been authorized by the Food and Drug Administration (FDA). As of now, it is a violation of federal law for pharmaceuticals to promote off-label alternative uses to doctors and other medical professionals. However, the law solely allows that they respond to unsolicited questions from medical professionals under strict conditions.

Conversely, it is technically legal for doctors to prescribe medication for unapproved uses if deemed medically appropriate. Physicians claim that the off-label use of medication could prove as an exercise of the standard of care, especially in circumstances when patients have exhausted all other approved options. Cancer treatment, for example, consists of extensive off-label use. According to the American Cancer Society, doctors have discovered that specific chemotherapy treatments approved to be used for one type of cancer could target complications caused by other types of cancers.

But many researchers remain skeptical of the intentions of pharmaceutical companies and their fervent efforts to eradicate the ban on the promotion of their drugs for off-label use. Questions regarding whether or not these companies are financially driven and prioritizing money over the health of patients have been posed. Ultimately, complete promotional freedom to doctors and consumers equates to billions of dollars in possible profits. But more importantly, it could compromise the health of patients on the receiving end of these medications. News that the FDA is actually considering these policy changes broke at the end of last year after they announced they would hold a public hearing to garner feedback on the expansion of off-label communications.

Backlash from consumer rights groups immediately followed. Public Citizen, a nonprofit group that lobbies for consumer representation through advocacy efforts, has been very vocal regarding the dangers of the FDA altering its policy.

They testified at the meeting held by the FDA in November of last year, claiming that the policy “undermines the long-standing regulatory framework for ensuring that medications and medical devices are safe and effective for their intended uses.”

For now, the general public awaits the FDA's decision.

If you or a loved one has been injured due to a mistake made on behalf of a medical professional, you may be entitled to compensation. Qualified Attorneys Charles Gilman and Briggs Bedigian are dedicated to winning you the compensation you rightfully deserve. Call their office at (800) 529-6162 or contact them online. The firm handles cases in Maryland, Pennsylvania, and Washington, D.C.

About the Author

Charles Gilman

As managing partner and co-founder of Gilman & Bedigian, it is my mission to help our clients recover and get their lives back on track. I strongly believe that every person who is injured by a wrongful act deserves compensation, and I will do my utmost to bring recompense to those who need and deserve it.

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