The FDA Failed to Protect People from Opioids
The Food and Drug Administration failed to properly police one of its programs that tries to reduce the number of opioids being prescribed. This occurred while opioids became a larger and larger problem for people around the country. The program, which started in 2011, helped to pay for safety training and helped track training to try and help reduce addiction, overdoses, and death. It ended up not being effective because the manufacturers did not collect the right data. After finding out that the right data was not collected, the FDA did not correct the behavior and let it happen. If the FDA did what it was supposed to do, there might not be a crisis today.
The 2011 program was supposed to help train half the doctors that prescribed opioids and teach patients the risks and dangers of opioid medications. The agency’s internal documents show that the agency had no idea if the safety strategies were working because the studies made to measure the effectiveness were poorly made and gave no good data. A spokesman for the FDA refutes that the agency gave up trying to evaluate the success of the education program, saying that it took many steps to test the program’s efficacy.
The FDA is being criticized for letting pharmaceutical companies monitor their own safety procedures as well as not checking if prescriber training was at a high enough standard. There were also early warnings showing that there was industry influence in the programs. An expert committee on the treatment of pain voted against the program design because industry influence was found in the program, but the FDA went forward with it anyway. The Department of Human Health released a report saying that only 14 percent of the FDA’s programs met their criteria. Another report just last year found that the FDA does not have the authority to do anything about a company that does not report enough information.
Another problem is that the FDA wanted 60 percent of prescribers to take their classes, but only 27 percent took them in a four-year span. Surveys found that prescribers who took the classes had better knowledge of prescribing practices, but the surveys did not tell them whether the doctors prescribed less because of the classes. The program also did not assess if the program prevented death. National data was used which did not consider whether a patient or doctor took the class.
Until heroin and fentanyl surpassed them, prescription drugs were the largest cause of overdose deaths in the United States. The opioid prescription rate peaked at 81.3 prescriptions per 100 people in 2012 and lowered to 58.7 prescriptions per 100 people in 2017. The prescription rate is still high and needs to be fixed. The FDA needs to put more regulations in place to help stop this crisis and protect people from becoming addicted to these harmful drugs.
Goldberg, Persky and White, P.C is co-counsel in a lawsuit against eight pharmaceutical companies. We are seeking compensatory and punitive damages from these companies for their role in creating and fueling the opioid crisis.