Is the FDA responsible for the opioid epidemic, the most damaging medical crisis to hit the United States since the turn of the century? There appears to be strong evidence that a single action taken by the FDA in 2001 triggered the crisis. But the blame doesn’t fall entirely on the FDA for the resulting epidemic.
Big Pharma, Big Money, Bad Decisions
Initial research and testing of Oxycontin determined that the drug was only effective for short term use. In 1995, the FDA first approved the drug with those labeling guidelines. Following this action, Ed Thompson, the developer of Oxycontin and many other opioids for the pharmaceutical industry, told reporters that big pharma began to pressure the FDA to change its labeling even though there was no scientific data to back their demands.
60 Minutes requested, and obtained, the records of a 2001 meeting between the FDA and Purdue Pharma, the manufacturer of Oxycontin. The minutes show that the FDA did cave to the pharmaceutical company’s undocumented demands for a labeling change authorizing long term, around the clock use.
This decision opened the floodgates, allowing millions of opioid doses to flow through the distribution channels to the American public. It was to be the first of many bad decisions by government agencies due to the money and pressure used by big pharma and their lobbyists. And, it is the decision many point to and say, “The FDA is responsible for the opioid epidemic.”
Enter the DEA
The DEA eventually became involved and began investigations to fulfill their duty of keeping dangerous drugs off American streets. However, as they started to file charges and actions to hold the pharmaceutical companies responsible, they were stonewalled – by the DEA’s legal department.
Investigations by 60 Minutes and The Washington Post obtained the cooperation of DEA whistleblower, Joe Rannazzisi. He oversaw several field agents who came back with reports of vast numbers of opioid pills being sent down to pharmacies. Mr. Rannazzisi and his team tried to bring a case against the pharmaceutical distributors, and that’s when the stonewalling began. The DEA’s attorneys, under pressure from the industry, decided a “softer” approach was in order.
DEA lawyers started to switch sides and began lobbying for the pharmaceutical industry. Nearly all the DEA cases ground to a halt. At the same time, the drug industry lobbied Congress for legislation to limit the enforcement powers of the DEA. That legislation passed into law and took away the DEA’s ability to freeze suspicious shipments of prescription narcotics.
The DEA continued trying to hold the distributors accountable despite limited powers. In 2017, DEA Assistant Special Agent David Schiller and his team attempted to bring a case against McKesson, the largest drug distributor in the country. McKesson was sending countless millions of pills to pharmacies with no effective control and reporting process. It sounded like a ship and forget operation.
Once again, the DEA lawyers and the DOJ took the path of least resistance. According to Mr. Schiller, the lawyers at both agencies were afraid to go up against the powerful legal teams representing McKesson. Instead of seeking fines of $1 billion, they settled for a fine of $150 million. People point to these types of actions when they claim the FDA is responsible for the opioid epidemic.
Doctors in the Mix
Doctors also factor into the epidemic, some criminally. Without a doubt, Oxycontin is a powerful pain killer. Used properly, there are few risks. The FDA labeling change took away the scientifically validated safeguards. Instead of a specialty, limited-use drug, doctors now could prescribe it for any pain and for any length of time.
The most prominent criminal case involving a doctor took place in Florida. This physician was sentenced to 157 years in jail for over-prescribing Oxycontin. The doctor’s argument that he used the prescriptions to do good for his patients and alleviate chronic pain rings hollow when you see the numbers.
Over eight months, he prescribed 18,000 pills to one patient! His in-practice pharmacy prescribed more than 800,000 pills over 16 months. Mallinckrodt, the largest distributor of the drug in Florida, accounted for 500 million pills shipped to the State between 2008 and 2018, two-thirds of the total distributed. DEA action against Mallinckrodt was once again stymied, and the company was fined $35 million, less than a week of revenue according to 60 Minutes.
FDA Responsible for the Opioid Epidemic? They Had Help
In the final analysis, the FDA alone is not responsible for the epidemic. They served the role of the spark igniting the wildfire. Fear and money let the big pharmaceutical companies get away with flooding the markets without consequence.
The FDA is taking action, and you can read more about that here
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM587297.pdf. But is it a case of too little too late? It will take years to untangle and reverse the damage.
So is the FDA responsible for the opioid epidemic? It is clear they had plenty of help. The current efforts of the FDA and other agencies to correct the mistakes are little comfort for anyone suffering from opioid addiction, or who knows or lives with someone suffering from it. While they clean up the mess, people need help. CARUS Recovery is Southern California’s premier addiction recovery center. Our detox and recovery programs may be the help you need. Call 877-225-7724 or contact us today. Recovery can start with this single act.