FDA hustles on opioid guidance to avoid budget meddling

Drugmakers certainly respond to financial incentives, and disincentives, so why not the FDA? In fact, it is rushing to complete guidance on abuse-deterrent opioids before the end of June because if it doesn't, Congress has promised to take away $20 million in money for salaries and expenses in the FDA Commissioner's Office and give it instead to its criminal investigations unit to fight drug diversion.

An FDA spokesperson tells MedPageToday the agency is quite aware of the financial stipulation and is "working to finalize the guidance before the June 30, 2015 deadline."

"It's a lot of money and the FDA is going to respond to that," said Dan Mendelson, CEO of Avalere Health, a firm that tracks healthcare policy, tells MedPageToday. "You always try to get rid of language like that because it does tie your hands."

Some members of Congress and the FDA have been sparring for several years over its approvals of more opioid-based drugs, which have become the drugs of choice for many abusers because of the heroinlike high. Politicians, supported by legions of law enforcement and others, savaged the FDA last year for approving Zohydro, first all-hydrocodone pain reliever ever cleared by the FDA, making it the first approved pure opiate and one that had no deterrent technology incorporated.

The FDA has been clear that it does not believe the abuse-deterrent technologies currently on the market are sophisticated to actually foil abuse. Critics have said there is a opioid abuse epidemic in the country, citing escalating overdose deaths and that more must be done.

Zohydro's developer, Zogenix ($ZGNX) last month got approval for a version that it said uses a technology that turns the drug into a viscous gel if it's crushed and dissolved in liquids or solvents. But the FDA wanted more data from the company before allowing it to make abuse deterrent claims on the label. Instead, Zogenix two weeks ago sold the drug to New Jersey's Pernix Therapeutics ($PTX), in exchange for a $100 million upfront payment and up to $283.5 million in milestones.

The FDA has approved four pain drugs with abuse-deterrent labeling, Purdue Pharma's Targiniq, Hysingla, and a reformulated Oxycontin, as well as Pfizer's ($PFE) Embeda. But some in Congress want guidance and they want it now, so drugmakers can do a better job of developing opioid drugs that might turn the tide on abuse and overdoses. And if the FDA doesn't give them guidance ASAP, then it is the agency that will pay the price.

- here's the MedPageToday story

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