The FDA is considering quicker U.S. approval for obesity treatments, life-saving antibiotics and other drugs believed to offer societal benefit despite their risks. Obesity not only affects one third of the U.S. adults but also the well-being of patients and is a major public health concern. “A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good,” said Allan Coukell, deputy director of medical programs for the Pew Health Group in Washington.
Margaret Hamburg, FDA Commissioner is considering putting a “special medical use” label on the prescription which allows doctors to administer the drugs to patients in most dire need. This would help potential takers of Belviq and Osymia, two obesity pills that were approved earlier, still have restrictions to those who are obese or more than 59 pounds overweight and have at least another condition such as high blood pressure or diabetes. This is a topic that has risen over time is becoming well known. Click here to read an article in Bloomberg BusinessWeek which shares more insights about the potential for the quicker approval pathway. For assistance with your regulatory submission, contact Pearl’s regulatory experts at contact@pearlpathways.com to learn more.