Regulatory Focus™ > News Articles > Proposed Legislation Overhauls Regulatory Environment for Tamper-resistant Opioids

Proposed Legislation Overhauls Regulatory Environment for Tamper-resistant Opioids

Posted 24 July 2012 | By Alexander Gaffney, RAC 

A new piece of legislation proposed in the US House of Representatives would provide pharmaceutical manufacturers with incentives to develop tamper-resistant products by changing the rules of the competitive landscape.

The Stop Tampering of Prescription Pills Act of 2012, introduced by Rep. Bill Keating (D-MA) on 19 July, would first amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to include a definition for "tamper-resistant drug[s]."

Such a product would, under the proposed definition, be an orally-administered opiate-based product formulated to either "make product manipulation significantly more difficult or ineffective" or deter abuse through the addition of other inactive ingredients.

New Regulatory Incentives

More importantly, a drug meeting the definition of a "tamper-resistant drug" would be eligible for additional regulatory incentives-and disincentives if they fail to prove tamper-resistance.

Any generic drug product referencing an Orange-book listed product with a tamper-resistant formulation must also demonstrate comparable tamper-resistance. If it does not, FDA is ordered to refuse the drug unless it is "necessary either to prevent or alleviate a drug shortage or to otherwise address a significant unmet public health need."

505(b)(2) applications-or applications similar to an originator product, but not generic to it-would also be required to have a tamper-resistant formulation if the referenced product does as well. An exception is granted if the referenced product had been discontinued.

The bill could lead to many branded pharmaceutical manufacturers adopting tamper-resistant formulations in order to obtain additional exclusivity. Another provision of the law deems as un-equivalent any generic product that fails to keep up with its reference-listed drug's tamper-resistance status, regardless of the generic drug's previous approval status.

Conversely, it is also possible that enterprising generics manufacturers could develop a tamper-resistant formulation for its product, obtain approval for it, and kick its competitors-including the original manufacturer-off the market.

Read more:

Stop Tampering of Prescription Pills Act of 2012

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