What did the FDA do to curb fentanyl’s role in the opioid epidemic? For years, not much.

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by Jim Orr

The powerful painkiller known as fentanyl was approved by the Food and Drug Administration in 1998 to treat opioid tolerant patients with severe pain, such as cancer patients. But in the years following the drug’s approval for use outside of a hospital setting, doctors increasingly began to prescribe fentanyl to patients who were not opioid-tolerant or to patients with less severe pain, such as back pain or post-surgical pain.

One reason for the increase in fentanyl prescriptions to patients who were not approved for the drug under FDA guidelines is the agency’s own failure to monitor how the drug was being prescribed. According to a new study conducted by researchers at Johns Hopkins, although the FDA set up a fentanyl safety monitoring program in 2011 to help curb off-label prescriptions, the agency left it up to the manufacturers of fentanyl products to enforce the program.

Recognizing the danger of prescribing fentanyl to non-opioid tolerant patients or patients with less-severe pain, the FDA set up a distribution oversight program that was intended to reduce off-label fentanyl prescriptions. This program showed that fentanyl was frequently being prescribed to patients who were not eligible to take the drug under FDA guidelines, according to the data obtained by Johns Hopkins researchers.

FDA entrusts fentanyl manufacturers and distributors with monitoring off-label prescriptions

But instead of taking steps to curb these off-label prescriptions, the FDA entrusted the manufacturers and distributors of fentanyl products to enforce its own regulations. Unsurprisingly, these companies – some of whom were earning record profits in large part because of these off-label fentanyl prescriptions – did little to curb the growing use of fentanyl among patients who had not been approved to take the drug under FDA guidelines.

The pharmaceutical distributor McKesson was tapped by the FDA to administer the program. Many drug companies who manufacture transmucosal immediate-release fentanyl (TIRF) products were entrusted with enforcing the FDA’s regulations. TIRFs are quick-absorbing fentanyl sprays, tablets, or lozenges developed over the last two decades as an alternative to the fentanyl pain patch. Some examples of TIRFs include the fentanyl spray, Subsys, manufactured by Insys Therapeutics; the fentanyl lollipop, Actiq, which is made by Cephalon; and the fentanyl tablet Fentora, which is also sold by Cephalon.

With fentanyl distributors and manufacturers in charge of enforcing the FDA’s regulations, off-label prescriptions of TIRFs and other fentanyl products flourished. According to FDA documents, about 40% of doctors who prescribe TIRFs said that they had prescribed these drugs for chronic pain in violation of FDA rules.

Off-label fentanyl prescriptions help fuel the opioid epidemic

The failure of fentanyl distributors and manufacturers to control the off-label prescriptions of these drugs helped fuel the mistaken belief among doctors and patients that these prescribing practices were safe. According to a survey conducted by the FDA, 42% of pharmacists thought that the off-label prescription of TIRFs and other fentanyl products were acceptable. Another survey found that 18% of doctors and 48% of patients wrongly believed that the FDA had approved fentanyl for these off-label uses.

These off-label prescriptions helped fuel record profits for TIRF manufacturers. A month prescription for these drugs can cost as much as $30,000. As doctors increasingly prescribed fentanyl for off-label use, Insys, Cephalon, and other manufacturers of TIRFs were raking in billions in profits.

Even though the increased off-label use of fentanyl was putting thousands of patients at an increased risk of an overdose, the companies who were charged with enforcing the FDA’s rules actually made it easier for doctors to prescribe TIRFs to patients who were not approved to take these drugs. The companies removed language from a mandatory agreement that doctors and patients are required to sign before TIRFs are prescribed. This language required doctors to attest to the fact that the patient receiving the prescription is opioid tolerant. The new language only required doctors to affirm that they knew the meaning of “opioid tolerance.” Patients were also no longer required to affirm that they were taking round-the-clock opioids, an important prerequisite for being prescribed fentanyl under FDA rules.

Experts say that the FDA had the authority to force the companies administering its fentanyl prescribing program to take tougher measures to reduce off-label prescriptions of these drugs. But although the agency held several video conferences with fentanyl manufacturers in 2017 to discuss plans to study the risk of side effects from fentanyl in patients who were not opioid tolerant, it failed to take steps to force TIRF manufactures to curb the off-label use of these products.

Experts say that the FDA’s failure to enforce regulations on the prescription of opioid painkillers had played a role in the opioid epidemic that claims the lives of tens of thousands of Americans each year. In the early 2000s, the FDA let Purdue Pharma run a risk management program for the drug OxyContin, which played a key role in fueling the opioid crisis. Purdue Pharma was forced to pay more than $600 million in fines for false advertising involving OxyContin in 2007. After Johnson & Johnson’s narcotic pain reliever Tramadol was approved in 1995, the FDA allowed a steering committee funded by the company to monitor abuse of the drug instead of classifying it as a controlled substance. Tramadol was finally classified as a controlled substance in 2014.

Many manufacturers of TIRFs have also faced fines or lawsuits involving false advertising of these products. Cephalon was forced to pay $400 million in fines for false advertising involving the use of the Actiq fentanyl lollipop to treat migraines. Executives with Insys, maker of the fentanyl spray Subsys, have faced criminal charges over a bribery scheme to encourage doctors to prescribe the drug off-label. McKesson was forced to pay $150 million in fines for failing to report suspicious opioid prescriptions to authorities.

Lawsuits filed by HO&P on behalf of fentanyl overdose victims

Lawsuits against doctors who prescribed fentanyl, distributors and pharmacies who supplied the drugs, and pharmaceutical companies who manufactured fentanyl products have been filed across the U.S. by families who lost a loved one to an overdose. If a member of your family or another loved one has suffered an overdose caused by fentanyl, you may qualify to file a lawsuit.

The lawyers at Heygood, Orr & Pearson have filed more lawsuits involving the fentanyl pain patch than all other law firms in the U.S. combined. Our attorneys have years of experience in fentanyl litigation and will work hard to ensure that you are fairly compensated for the harm your family has suffered as a result of fentanyl.

For more information about filing a fentanyl lawsuit and to find out if you qualify to file a case, contact the law firm of Heygood, Orr & Pearson by calling us toll-free at 1-877-446-9001. You can also reach us by following this link to our free fentanyl case evaluation form and answering a few brief questions to get started.