By Steve Heintz of Heintz & Becker on Wednesday, January 13, 2016.
Is the U.S. Food and Drug Administration (FDA) making the right decisions when it comes to the issue of painkillers and children, or has it become a pawn of the pharmaceutical industry? Some are saying that a recent FDA decision is flawed and may put our children at risk of becoming the next generation of drug addicts.
In August, the FDA issued a shocking approval of the use of the narcotic painkiller OxyContin for children as young as 11 in certain situations. Just as shocking was who the FDA got the information it relied on in making its decision from: Purdue Pharma of Stamford, Conn., the pharmaceutical company that manufactures the drug and who stands to make big money from the FDA approval. That same company admitted to falsely playing down the addictive nature OxyContin just a few years earlier.
OxyContin is an extremely powerful and highly addictive long-release version of oxycodone which is intended to be limited to patients with severe and chronic pain. It's also a drug of choice for many drug addicts. Shortly after the FDA's announcement, U.S. Senator Joe Manchin wrote that he was "disgusted" by the decision, saying the decision was "reckless" and "a horrifying example of the disconnect between the FDA approval process and the realities the deadly epidemic of prescription drug abuse are having on our communities" that "endangers the lives of our most precious asset and the nation's future: children."
While it is true that doctors need to be able to treat children in severe pain, such as those suffering from bone cancer or who have undergone spinal surgery, several members of Congress sent a letter to the FDA in December strongly urging it to reconsider its decision. The letter criticizes the FDA's decision-making process, saying "as other federal agencies...work to combat this growing epidemic, we find it startling that the FDA took this action without the benefit of review and input from an Advisory Committee. And, most egregiously, that the FDA relied solely on an evaluation conducted by the pharmaceutical company who stands to benefit from the sale of this drug."
Unfortunately, the ongoing arguments and accusations are of no help to parents who may be faced with agonizing medical care decisions for their children. Heintz & Becker provides legal representation for families of children who have suffered extreme pain after being injured in traffic crashes or other accidents. Our attorneys know that the parents of these children often suffer just as much as they try to comfort their children and find the right doctors who can safely treat their children's pain. If your child is suffering from extreme pain due to someone else's negligence, please contact one of our attorneys for a free, no-obligation evaluation of your claim for financial compensation on behalf of your child.
Source(s): telegram.com, "Increased opioid addiction feared", posted January 9, 2016; NBC News, "FDA Approves OxyContin for Children as Young as 11", posted August 14, 2015, posted September 21, 2015; Congresswoman Niki Tsongas, "Press Release: Tsongas leads letter to FDA urging reconsideration of decision on OxyContin use by children", posted December 22, 2105; U.S. Senator Joe Manchin, "Press Release: Manchin Condemns Outrageous FDA Decision to Approve OxyContin for 11 Year Olds", posted August 17, 2015