A bipartisan effort in Congress to make more opioid painkillers tamper resistant could also make generic forms of the drugs more costly, according to experts.
Rep. Mary Bono Mack (R-California) and Rep. Bill Keating (D-Massachusetts) have introduced legislation called the “Stop the Tampering of Prescription Pills” (STOPP) Act. If passed, it would require the Food and Drug Administration to order generic drug makers to use tamper resistant formulas to make it harder for drug abusers to inhale or inject narcotic painkillers.
“Today, people try to get high by crushing pills into powder, chewing them, dissolving them in water, or by injecting them. What we hope to do is make opioid painkillers tamper resistant. Technologies exist today to make it much more difficult to abuse these medicines,” said Rep. Bono Mack during a news conference with Keating.
Under the STOPP Act, if a drug presently on the market has a tamper-resistant feature, then all other drugs with similar chemical properties must have that feature as well. Companies that refuse to reformulate their generic versions would be told by the FDA to withdraw the drug from the market.
“It becomes a ‘use it or lose it’ proposition,” said Bono Mack.
In 2010, Purdue Pharma changed the formula for its widely prescribed painkiller OxyContin, making the drug harder to crush and dissolve. The reformulation led to a drop in sales of OxyContin, as many drugs abusers switched to other painkillers that were not tamper resistant or started using heroin to get high.
Patents for OxyContin and Opana, another popular painkiller, are due to expire next year. The FDA hasn’t said if it will require generic versions of the drugs to be tamper resistant.
“The STOPP Act will make tamper-resistant painkillers the norm, not the anomaly. This alone will not solve the problem, but it’s a proactive step in the right direction that might save hundreds of lives across the country,” said Rep. Keating.
Keating and Bono Mack are both members of the Congressional Caucus on Prescription Drug Abuse and the Youth Drug Caucus. Bono Mack became a leading congressional voice on the issue of prescription drug abuse after her son became addicted to OxyContin and went into rehab.
A spokesman for an industry trade group told the Wall Street Journal the STOPP Act could make generic painkillers more expensive or keep them off the market.
“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 Ralph G. Neas, president of the Generic Pharmaceutical Association. “Policy makers should let the medical evidence guide actions in addressing this critical issue.”