Bill Would Require Tamper-Resistant Formulas for Certain Drugs

A new bill introduced Friday in the U.S. House of Representatives would require new drugs, and certain generic drugs, to have tamper-resistant formulas, ABC News reports. The proposed legislation is designed to reduce prescription drug abuse.

The Stop the Tamper of Prescription Pills Act (STOPP) would require the Food and Drug Administration (FDA) to only approve drugs if they have a tamper-resistant formula. Drugs in pill form could not be easily crushed and snorted, and could not be melted into an injectable form.

The measure would also require generic brands already on the market to be tamper-resistant, if their brand-name equivalents had a tamper-resistant formulation. It would not apply to drugs prescribed for chronic pain or end-of-life treatments. The FDA would be permitted to exempt drugs considered critical to national health, or in cases where a drug does not have a tamper-resistant alternative.

Bill co-sponsor Bill Keating of Massachusetts introduced the STOPP Act last summer, but it stayed in committee. Measures that would require generic drugs to have tamper-resistant formulas have been opposed by some generic drug manufacturers, who have argued it would lead to higher drug costs.

Representative Hal Rogers of Kentucky, another sponsor of the bill, noted in a press release, “When OxyContin was first approved by the FDA over a decade ago, it seemed at first glance that its extended-release technology was a godsend for patients suffering from chronic pain. What no one could foresee was that when you crush these pills, they actually create pain in the form of addiction, abuse and senseless, tragic overdose deaths. Now we’ve got some promising technology to deter abuse, as well as the benefit of hindsight. This time around, we can see the train coming from a mile away – and we need to step out in front of it to stop another tidal wave of addiction.”

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    karen gravina

    March 18, 2013 at 10:30 PM

    Tamper proof? they should be “controlled substances” not marketed. the train’s already hit. No one could forsee? I think the industry has a pretty good idea of what products they’re putting on the “market”.

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