A bill introduced in the House of Representatives would ban from circulation certain pharmaceuticals that could be easily abused as recreational drugs.
The proposed legislation is aimed at variants of addictive painkillers and other oral medications.
Reps. Bill Keating, D-Mass., and Hal Rogers, R-Ky., made the announcement at a news conference on Capitol Hill today. Keating said the legislation, if passed, would help curb a “silent epidemic” of prescription drug abuse.
“If this were the swine flu or any other kind of disease, this would be making headlines all over the country,” he said. “But because of the stigma that is often attached to this, it is not.
“The increase in abuse and deaths attached to these prescription drug overdoses is occurring at a rate even more than heroin and cocaine,” he said, citing a recent study from the University of Michigan on teenage narcotic use.
The bill would require the Food and Drug Administration to refuse to approve any new pharmaceuticals that did not use formulas resistant to tampering. For example, pills should not be able to be easily crushed into powders that could be snorted, or melted down into a liquid form that could be taken through injection.
Called the Stop the Tampering of Prescription Pills Act, or STOPP, the law would also apply to generic brands already on the market if their brand-name drugs had adopted tamper-resistant formulas.
Keating demonstrated using two pills and a hammer. The pill that could be easily smashed into a fine dust would be banned under the new guidelines. The pill that retained its shape would not.
Michael Barnes at the Center for Lawful Access and Abuse Deterrence was present for the announcement, and spoke with ABC News after the demonstration. He explained that the tamper-resistant pill in the demonstration would shatter into large, solid chunks if enough pressure was applied – not a form that could be snorted. A tremendous amount of force would be required to turn it into a powder. Conversely, if the pill was melted, it would revert to a gelatinous liquid that could not be forced through a syringe, Barnes said.
The Centers for Disease Control and Prevention estimates that 38,000 died in 2010 from drug overdoses, and pharmaceuticals were involved in nearly 60 percent of the cases, eclipsing illegal narcotics. That death rate recently exceeded those related to motor vehicle accidents for the second year in a row.
This is the second time members of the Congressional Caucus on Prescription Drug Abuse have pushed such measures. Keating originally introduced the STOPP Act in July, but it stayed in committee. Some generic pharmaceutical manufacturers have resisted attempts by the federal government to mandate similar measures, suggesting it would lead to higher costs for consumers.
Rural areas have shown a disproportionate share of abuse. Rogers said that in his state of Kentucky the time-released painkiller OxyContin was known by street names including “Proxies,” “Kickers” and “Hillbilly Heroin” before an abuse-deterrent formula was adopted by its manufacturer, Purdue Pharma, in 2010.
“In my district, at the height of this problem, the most dangerous job in eastern Kentucky was not coal mining, it was driving a Fed Ex or UPS truck, being robbed by people desperate and hooked on OxyContin. Pharmacies were being raided for pills. Once serene small-town communities were overridden with crime,” he said.
The FDA recently approved a generic variant of OxyContin to be made available next month that would not include an anti-tampering formula. Rogers, who has previously testified for the FDA to limit distribution of painkillers, called on Congress to pass the legislation before the April 15 release date of the generic.
“If the FDA will not act boldly, then the Congress will,” he said.
The STOPP Act would not apply to drugs prescribed to patients for chronic pain or end-of-life treatments. It would also grant the FDA the ability to waive pharmaceuticals deemed critical to national health, or in cases where there is no tamper-resistant alternative.