FDA, Califf to overhaul opioid approval process following intense public pressure
- The FDA will reassess its approach to approving opioid painkillers through a number of reforms aimed at addressing concerns over its role in the growing opioid crisis, said Dr. Robert Califf on Thursday. The current Deputy Commissioner for medical products, Califf is President Obama's nominee for FDA commissioner.
- A number of senators have opposed Califf's nomination over the past several weeks, most citing their desire to see the FDA change how it approves painkillers. Several senators placed legislative "holds" on Califf's nomination, effectively blocking the Senate from voting on his nomination.
- Among other reforms, the FDA will now convene advisory committees before approving any new drug applications for opioid painkillers that do not have abuse-deterrent properties.
The FDA and Califf have come under intense pressure from lawmakers as worries have grown over the increasing number of prescription drug overdose deaths in the U.S., many due to opioid painkillers such as OxyContin.
Sen. Ed Markey (D-MA) announced last week he would block the nomination of Califf for FDA commissioner. In particular, he wanted the agency to reverse its August 2015 decision approving OxyContin for pediatric use.
The FDA's reform proposals were responding to Markey's pressure, as the agency will consult with its pediatric advisory committee over pediatric opioid labeling. Additionally, the FDA will change immediate-release opioid labeling to bring warnings for those products in line with labeling for long-acting opioids.
"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," Califf said in a statement. The FDA will also try to improve access to naloxone, a treatment for opioid overdose.
Markey had promised to continue his legislative block on Califf's nomination until the FDA changed its approach. It is unclear if the announced reforms will meet Markey's concerns.
Separately, presidential candidate Sen. Bernie Sanders (I-VT) also placed a "hold" on Califf's nominations over his ties to the pharmaceutical industry, which Sanders believes will compromise his judgment as commissioner.
However, the reforms announced on Thursday should help lessen some of the legislative opposition to Califf's nomination.
Last year, 18,893 people died from prescription opioid overdose, a 16% year over year increase. Over the past decade, overdose deaths have increased by roughly 73%, rising in parallel with overall prescription growth.
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