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FDA plans new opioid painkiller approval rules following Senate fight over new commissioner nomination

The Food and Drug Administration has announced that it will overhaul its review process for opioid painkiller drugs. The announcement came following pressure from three U.S. Senators who had blocked the approval process of Robert Califf, who was nominated to lead the FDA by President Obama.

Overdoses and deaths from opioid painkillers have become a major epidemic in the U.S. over the last decade. More than 28,000 deaths due to opioid overdoses occurred in 2014, according to data from the CDC. The alarming number of opioid overdose deaths in the U.S. in 2014 was caused by a number of factors, including the aggressive marketing of opioid medications like OxyContin by their manufacturers and the growing willingness of doctors—including non-pain specialists—to prescribe these drugs to patients with mild or moderate pain. The FDA says that six out of every 10 deaths due to prescription drug overdose were caused by opioid painkillers—helping to make prescription overdoses the leading cause of accidental death in the U.S.

After President Obama nominated Califf to take over as head of the FDA, Sen. Edward J. Markey of Massachusetts announced that he would place a procedural hold on the nomination until the agency agreed to new measures to curb the abuse of oxycodone, hydrocodone, and other opioid painkillers. Two additional senators also placed holds on Califf’s nomination. Vermont Sen. Bernie Sanders, who is campaigning for the Democratic presidential nomination, cited Califf’s “close ties to the pharmaceutical industry and lack of commitment to lowering prices” as the reason for his nomination hold. Sen. Lisa Murkowski of Alaska also placed a hold on the nomination vote until the FDA agrees to mandatory labeling requirements for genetically engineered salmon.

The FDA’s new policy regarding the approval of opioid drugs will require pain medications that do not have built-in abuse-resistance properties to pass through an advisory review committee before they go on the market. This could make it harder for these drugs to win FDA approval. The new policy will also require drug companies to fund continuing education programs for doctors about the risks of prescribing opioid medication. The FDA says that it hopes these programs will help to reduce the frequency with which doctors prescribe opioids to patients.

Califf said that the FDA may consider other measures to reduce the number of overdoses and deaths caused by opioid painkillers. He says the agency will consider whether to make the drug naloxone—an antidote given to patients who have suffered an opioid overdose—available in non-prescription form. The FDA will also add new safety warnings to existing immediate-release painkillers, which are more likely to be abused. Califf said that if abuse-deterrent pain medications prove effective over the long term, immediate-release opioids may be phased out.

Sen. Markey—who placed the original hold on Califf’s nomination over the FDA’s policies on opioid medications—responded to the agency’s proposed new rules on opioids approval by stating that they did not go far enough to address the epidemic of opioid painkiller prescriptions in the U.S. “Whether an opioid is abuse-deterrent or not hasn’t prevented tens of thousands of people who have had their wisdom teeth removed or experienced lower back pain from getting addicted to these painkillers,” Markey said. “Until the FDA commits to convene advisory committees of outside experts for all its opioid approval decisions, I will continue my hold on Dr. Califf’s nomination.”

The FDA and other branches of the Department of Health and Human Services have also been working on additional plans to address the epidemic of opioid overdoses and abuse. President Obama says that he plans to request $1.1 billion from Congress in his next budget to address the tens of thousands of cases of abuse, addiction, overdose, and death that occur each year as a result of prescription painkillers. Sen. Patrick Leahy of Vermont—another critic of the FDA’s approval process for opioid drugs—said that the additional measures were “a step in the right direction, but the FDA can and must do more”.

Personal Injury Lawsuits Filed on Behalf of Opioid Overdose Victims

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 aggressive marketing of prescription painkillers by the pharmaceutical industry and the overprescription of opioid medications by doctors have played a key role in the rise of opioid overdoses in the U.S.

If you or a loved one has been the victim of an overdose or other serious complications caused by opioid overprescription, you may be eligible to file a lawsuit against manufacturer of the drug, or the doctor or hospital that was responsible for your injuries. The first step in taking legal action is to talk with a law firm with the experience and knowledge to successfully handle your case from start to finish.

The lawyers at Heygood, Orr & Pearson have represented numerous individuals who have been the victim of complications caused by opioid painkiller prescriptions. Our law firm has handled more cases involving the fentanyl pain patch—a powerful opioid painkiller that is about 80-100 times more powerful than morphine—than all other law firms in the country combined.

If you or a loved one has been hurt by side effects from opioid painkiller medications, the lawyers at Heygood, Orr & Pearson are ready to help. For more information about filing a lawsuit and to learn if you may be eligible to file a case, contact our law firm by calling toll-free at 1-877-446-9001, or by following the link to our free case evaluation form located at the top of this page and answering a few simple questions to get started.

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