By Ed Coghlan
The announcement by the FDA’s Robert M. Califf, M.D., is FDA’s Deputy Commissioner for Medical Products and Tobacco that the agency will increase its scrutiny of it called the “opioid abuse epidemic” has drawn a critical response from Patient Advocate Dennis J. Capolongo.
“Once again we see the FDA has caved to political pressures without considering the patient voice in the opioid debate,” Capolongo told the National Pain Report. “Although we understand and sympathize with those who have fallen victim to their own abusive behavior of pain management medications, the flip side is even more horrifying for those who legitimately require opiate access in order to make it through another day.”
Dr. Califf outlined a new approach by the FDA to address the opioid issues that included the following goals:
- The FDA will be more transparent and open in the approval process for this category of drugs.
- The FDA will improve its communication with the medical community about these drugs.
- Work to improve the information that’s available about opioid use and require drug-makers to strengthen post-market analysis of these drugs.
- Focus efforts on approving drugs that have the potential to help mitigate the crisis.
Capolongo, Director of the EDNC in Washington DC, has been critical of the FDA in how it has dealt, or he would tell you not dealt, with the epidural spinal injection safety issue. Since the crackdown on opioids began, Capolongo says the concerns of patients have not been included.
“Thousands of chronic pain patients nationwide, many with severe intractable and incurable conditions such as Adhesive Arachnoiditis, are horrified at how difficult it has become for their doctor to effectively treat their condition.”
“It is unacceptable,” he said,” that the FDA has carelessly lumped all opioid users as “addicted abusers” when in fact many are simply innocent victims of iatrogenic injury. Their use of opiates is not by choice or addiction but rather a justifiable requirement for any semblance of normalcy.”
Capolongo concluded: “Clearly the FDA has fallen victim to their own bureaucratic weight and misdirection. I call upon my fellow patient advocates to fight for a seat at that table, to speak for those who are feeling the direct impact of these careless acts, acts the FDA may not even be aware they’re making.”