Bill to Enhance Fines, Penalties for Falsifying Medical Products Passes Congress

| 24 September 2012

A piece of legislation set to increase the amount of fines and severity of penalties for counterfeiters and thieves of medical products has passed both the US House of Representatives and Senate by unanimous consent.

The legislation, known at the Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2010 (SAFE DOSES Act), was first introduced in March 2012 by Rep. James Sensenbrenner (R-WI).

As reported by Regulatory Focus in June 2012, the bill would make the theft of any medical device, pharmaceutical, biologic or other medical device a separate criminal act under Chapter 31 of the US Code. Also prohibited would be the falsification, alteration, forgery or labeling deceit of any medical product, including the possession, transport, sale or traffic of any such product.

The legislation subjects individuals to fines and other penalties if they are found to knowingly be in the possession of counterfeit or trafficked products. For people found to be guilty of more serious crimes, including "aggravated offenses" involving organizational activity or the use of threatened or realized violence, the Act provides for stiff penalties-up to 30 years in prison and minimum fines of $1 million for individuals.

The legislation has been something of an anomaly in an otherwise partisan Congress. The bill encountered unanimous support throughout its markup process in both chambers, passing in the House's Committee on Judiciary by a voice vote before passing the Senate Committee on the Judiciary with no opposition.

The bill now heads to President Barack Obama for his likely signature.


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