New FDA Commissioner Backs Painkiller Reform
The U.S. Food and Drug Administration's new commissioner pledges to fully back efforts to develop harder-to-abuse painkillers.
New Efforts to Reduce Addiction from Painkillers
The pledge comes after a widespread government reform to reduce fatal overdoses tied to prescription pain medications.
Dr. Robert Califf, the new Food Drug and Administration (FDA) commissioner, asserted that his agency could not combat the problem alone, but that they would do everything in their power to curb the harmful effects of painkiller addiction.
He laid out his plan to curb the epidemic of abuse related to opioids. Prescription pain medicine and illegal drugs like heroin fall under this umbrella. Working closely with “prescribers, professional associations, patient advocates, and state and local partners to encourage the safe use of opioid medications” is one part of his plan.
Califf also pledged to add stronger warning labels to the most commonly prescribed opoids. Further, the new painkillers hitting the market are harder to abuse. OxyCotin is now harder to crush for snorting and it turns into a jelly when dissolved so it is harder to inject. The FDA has approved 5 drugs like this and another 30 similar ones are being developed.
Public speakers warned against the dangers of over-stating the newfound safety in these abuse-deterrent drugs. It could create false assurance in doctors when they can still be abused by simply being swallowed. It is still not clear whether the new formula has actually led to a decrease in abuse or overdoses.
In 2014, fatal overdoses tied to opioids hit 28,000 which is the highest number on record according to officials.
Additional Efforts Continue
These re-formulated painkillers make up a small part of the 200 million opioid prescriptions written every year. They are written for a variety of reasons ranging from migraines to post-surgery pain.
The FDA is requiring additional studies from manufacturers to assess the long-term safety and effectiveness of long-lasting opioids since most are approved with only three-month or less studies.
The FDA will face many challenges since withdrawing a drug from the market takes new evidence and an extensive use of resources.