On the heels of new addiction-fighting measures from FDA, Congressional reps are introducing a bill that would put the onus on drugmakers to curb abuse. The measure would require pain drugs to be formulated to deter abuse.
Some drugmakers have taken that step voluntarily. Purdue Pharma, for one, rejigged its OxyContin formula to make the powerful opioid pills more difficult to crush or dissolve for illicit use. Endo Pharmaceuticals ($ENDP) formulated its Opana painkiller to be abuse-deterrent as well.
Both OxyContin and Opana are branded products. The bill would give FDA authority to yank regulatory approval for generic drugs that aren't redesigned with their own safety features. The agency has already been considering whether to require generic painkillers to be tamper-resistant, The Wall Street Journal reports, partly because OxyContin and Opana fall off patent next year.
The bill is co-sponsored by two Republicans and two Democrats. It's just the latest attempt by lawmakers to push through legislation aimed at fighting painkiller abuse. Drug industry leaders aren't happy about proposed restrictions. "The proposed legislation would be detrimental to patients and could potentially remove FDA-approved safe and effective generic medicines from those who rely on them," Ralph G. Neas, president of the Generic Pharmaceutical Association, told the WSJ.
- see the story in The Desert Sun
- read the WSJ piece