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| FDA Commissioner Margaret Hamburg |
As pharmacies began dispensing Zogenix's ($ZGNX) powerful new painkiller Zohydro this week, FDA Commissioner Margaret Hamburg found herself under increasing pressure to revoke her agency's approval of the drug and yank it off the market. But she's not about to cave in to the pressure, she told the U.S. Senate's Health, Education, Labor and Pensions Committee during a hearing on Thursday, according to Reuters.
"We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy," Hamburg said.
Zohydro is the first all-hydrocodone pain reliever ever cleared by the FDA, making it the first approved pure opiate. And it doesn't have abuse- or tamper-resistant features to stop addicts from crushing it to get an immediate high. That has raised the hackles of a range of critics, from 28 state attorneys general who asked the FDA to withdraw Zohydro's approval in December, to the grassroots organization Fed Up! Coalition, which petitioned Hamburg to rethink her position on the drug in late February.
Following Thursday's hearing, Senator Joe Manchin (D-WV) introduced a bill to force the FDA to withdraw Zohydro from the market. The bill also would prohibit future approvals of painkillers that don't have tamper-resistant features. A similar law has been introduced in the House.
"Because of this painkiller's high potential for misuse and abuse, Zohydro poses a severely dangerous threat to our communities in West Virginia and across our country," Manchin said in a statement obtained by the AP. Hamburg said in a statement the FDA hasn't had a chance to review the proposed legislation. But she warned during the hearing that the technology for making painkillers resistant to abuse was still in its early stages, according to the AP.
"It doesn't do any good to label something as abuse deterrent if it isn't actually abuse deterrent, and right now, unfortunately, the technology is poor," Hamburg said.
In the midst of all the controversy, Purdue Pharma--the company that originally developed and sold the highly abused pain pill OxyContin--said it has finished a Phase III trial of its extended-release formulation of hydrocodone bitartrate, and that indeed it is abuse-deterrent. The once-daily pill was designed with tamper-resistant features, according to the company. Purdue plans to file to the FDA for approval later this year.
- here's the Reuters story
- read more at AP