The Senate confirmation of Dr. Robert Califf to become the new FDA commissioner hit a snag recently when Massachusetts Democratic Sen. Edward Markey placed a “hold” on the nomination over objections to the agency’s approval process for opioid painkillers. Sen. Markey says that in recent years, the FDA has “willfully blinded itself to the warning signs” about the risks of opioid painkiller prescriptions, which have caused roughly 47,000 deaths since 2014.
Markey says that his decision to block the confirmation process of Dr. Califf was due to concerns about the agency’s approval of opioid painkillers following a meeting with Califf. The Massachusetts senator said that based on discussions at that meeting, he had little “confidence that under [Califf’s] stewardship the FDA would confront the highly problematic manner in which the agency is approaching these issues”.
Sen. Markey’s procedural hold will prevent the Senate from taking a vote on Dr. Califf’s confirmation as FDA commissioner for the time being. Markey has made a legislative priority during his time in the Senate of taking action to halt the epidemic of opioid overprescription and the high number of cases of painkiller abuse and addiction that have resulted from it.
Markey says that he wants the FDA to form an advisory committee to address any questions related to the approval of opioid painkiller medications so that the potential for addiction, abuse, and drug dependency can be considered during the drug’s approval process. He also says that he wants the FDA to reverse its decisions to approve the powerful painkiller OxyContin for children.
At the time of the FDA’s decision to approve the use of OxyContin for children, Markey said that he was concerned that the FDA failed to convene an advisory panel to study the issue of whether approving the powerful painkiller for younger patients was a good idea. Markey was one of eight senators who signed a letter to the FDA protesting the agency’s September 2015 decisions to approve the drug for children.
The FDA stopped convening advisory panels to review the safety of opioid painkillers following the agency’s 2013 decision to approve the painkiller Zohydro, Markey says. Although the FDA’s advisory panel raised concerns about the safety of Zohydro, the FDA chose to approve the drug anyway.
The epidemic of opioid painkiller overdoses has been a leading contributor to the rise in prescription drug deaths in the U.S. over the last two decades. Since 1999, sales of opioid painkillers in the U.S. have risen by an alarming 300%, due both to the aggressive marketing of these drugs by the pharmaceutical industry and the growing willingness of doctors to prescribe opioids, even when they may not be needed. As sales of opioid medications has climbed, so too have the number of overdose deaths caused by these medications. The CDC has reported that since 2000, the number of fatal overdoses due to prescription painkillers has doubled in the U.S.
When a loved one has been the victim of overdose caused by opioid painkillers, the manufacturer of the drug—or the doctor or hospital who prescribed them—may be to blame. Sometimes doctors prescribe too many of these powerful painkillers, sometimes doctors prescribe these potent drugs in dosages that are too high, and sometimes doctors prescribe them with other drugs that can cause dangerous and even fatal drug interactions. The aggressive marketing of prescription painkillers by the pharmaceutical industry has also played a key role in the rise of opioid overdoses in the U.S.
The lawyers at Heygood, Orr & Pearson have represented numerous clients who have been the victims of overdose or other complications caused by excessive painkiller prescriptions by doctors or hospitals. In fact, the attorneys at our law firm have handled more cases involving the fentanyl pain patch—a powerful opioid painkiller about 100 times more potent than morphine—than all other law firms in the country combined.
If you or a loved one has been the victim of complications from an opioid overdose, the doctor or hospital who prescribed these drugs may be to blame. For more information about opioid painkiller lawsuits and to find out if you are eligible to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by completing our free case evaluation form located on the top of this page.