Bill Would Require Most Painkillers to Have Safeguards to Prevent Abuse
A bill to be introduced Thursday in the U.S. House would require most painkillers to have safeguards to prevent abuse, The Wall Street Journal reports.
Under the provisions of the bill, most prescription painkillers would have some form of abuse deterrence, such as being more difficult to crush or inject. The exact details of how drug manufacturers could meet the new standards are vague, the article notes. The bill does not set time lines for compliance.
If pain medications did not adopt the safety features outlined in the bill, they would be removed from the Food and Drug Administration’s (FDA) approved list of generic drugs. While several brand-name painkillers, such as OxyContin and Opana, have tamper-resistant formulations, most generic painkillers do not.
Patents for OxyContin and Opana are set to expire in 2013. The FDA has not yet ruled whether abuse-deterrent features will be required on the generic versions of those drugs.
“This bill should help protect first-time users and younger people who gain access through relatives or their own family’s medicine cabinets,” the measure’s lead sponsor, Rep. Bill Keating of Massachusetts, told the newspaper. Congress is “understanding the scope of this and looking at it as a major public health epidemic,” he added.
He said there is broad bipartisan support in the House for the measure. The bill’s cosponsors are Republicans Mary Bono Mack of California and Hal Rogers of Kentucky, and Democrat Stephen Lynch of Massachusetts.
The Generic Pharmaceutical Association opposes the bill. “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,” said the group’s president, Ralph G. Neas. “Addressing prescription-drug abuse is of utmost importance to the generic pharmaceutical industry. Policy makers should let the medical evidence guide actions in addressing this critical issue.”