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FDA fails to rein in drug makers who exploited patient-protection program, says report

May 16, 2018 opioid


FDA fails to rein in drug makers who exploited patient-protection program

A recent national investigation by Raycom Media has indicated that federal agency the Food and Drug Administration (FDA) allowed some drug makers and doctors to exploit the patient-protection program. The FDA did not give heed to the fact that that McKesson Corp. and other drug distributors helped fuel the opioid epidemic by pressuring pharmacies and doctors to prescribe their medications to the patients. As if this was not enough, the FDA even went to the extent of assigning McKesson with the responsible job of overseeing fentanyl prescription behavior.

Supply of fentanyl formulations has increased in recent years and is responsible for a large number of overdose deaths. The drug is at least 50 times more powerful than heroin and morphine, and therefore, there is a protocol for its prescription, distribution and safe use. Fentanyl overdose and related deaths are being reported from various quarters of the nation. However, those who are lucky are admitted to addiction drug rehabs, and gain sobriety, but not all are so lucky.

The FDA has made it mandatory for prescribers, pharmacists and distributors to enroll into a risk-management certification program, known as the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS), before either prescribing or dispensing these medications to cancer patients living in extreme pain. However, there has been laxity on part of the FDA, admitted by spokesperson of the agency Michael Felberbaum in an email, saying that the REMS oversight did not limit off-the-label prescription rates. Because of government apathy, prescriptions for fentanyl as well as the associated risks have gone up tremendously. What makes matters worse is that in most instances, it is the taxpayers’ money that is used for funding the wrongful treatment through Medicare. A single prescription for a month-long fentanyl dose can cost anywhere around $35,000 and that too for patients who may not need it. There seems to be serious gaps in patient safety management.

Laxity in TIRF-REMS

The TIRF-REMS program was launched in 2012 with an aim to prevent abuse, misuse and addiction to fentanyl and its analogs. The FDA website clearly states that “TIRF medicines are indicated only for the management of breakthrough pain in adult cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.”

But the investigation revealed that surprisingly, neither the agency was aware about the participating doctors nor prescribers who have violated the program guidelines. It is yet to explain how the oversight responsibilities were given to McKesson. According to FDA and McKesson, there is no contract between the two. What is even more interesting is that the distributor was hired at the behest of the makers of TIRF drugs. Former supervisor of the Drug Enforcement Administration Bill Renton talked about the obvious conflict of interest and said, “I really don’t know how big pharma got involved in managing a program designed to control big pharma.” Richard J. Hollawell, a New York-based lawyer who has been actively pursuing opioid-related cases for almost 10 years now, calls the program a sham where no one is serious enough to take ownership.

Big Pharma companies such as McKesson has played a major role in the current opioid crisis. In 2017, the Department of Justice had fined the distributor a whopping $150 million penalty for failing to uncover suspicious activity relating to opioid orders. Back in 2008 as well, the company agreed to pay $13.25 million civil penalty for violations of the Controlled Substances Act (CSA).

Recovery from drug addiction

Drug overdoses resulted in more than 63,000 deaths in 2016 and 66 percent involved a prescription opioid or an illicit drug. There has been a sharp and steady increase in deaths caused due to illicitly manufactured fentanyl and other synthetic opioids. The responsibility to stop the devastation does not only rest with the federal and state authorities but also with people who need to understand the ill effects of drug abuse and addiction.

If you or your loved one is addicted to any drug, experts at Recover Mental Health can help you connect with the best drug treatment center in your vicinity. Call at our 24/7 helpline (866) 593-2339 or chat online with our representative to know about evidence-based drug rehab programs that can help attain sobriety.

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