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Regulatory News | 06 January 2015 | By Alexander Gaffney, RAC
New legislation introduced in the US House of Representatives just prior to the holiday break would amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to increase penalties on the sale or trade of counterfeit pharmaceuticals and also grant the US Food and Drug Administration (FDA) new authority to recall drugs.
The proposed legislation, The Counterfeit Drug Enforcement Act of 2014, was introduced on 11 December 2014 by Rep. Steve Israel (D-NY), and is similar to an identically named piece of legislation introduced in 2003, 2005, 2007 and 2009.
The bill, if passed into law, would allow federal officials to sentence anyone found guilty of "knowingly" causing a drug to be adulterated or misbranded for a period of time up to and including life in prison. That's significantly longer than current law (21 § USC 333), which calls for any person found guilty of intending to defraud or mislead to be imprisoned for up to three years [(a)(2)] or up to 10 years for distributing drugs [(b)(2)].
In addition, a manufacturer made aware that its drugs may have been adulterated or misbranded must communicate that information to FDA within 48 hours, the bill states.
FDA would also be given an extra $60,000,000 to investigate counterfeit medications in 2015, 2016, 2017 and 2018 under the law.
In addition, FDA would be permitted to order companies to recall a drug after holding an "informal hearing" within 10 days of notifying the company that it must cease distribution of a drug. FDA's Chief Counsel would also be given the authority to issue subpoenas related to drug counterfeiting investigations.
If passed, the law would be at least the third in recent years to address drug counterfeiting and penalties for counterfeiting. The Drug Quality and Security Act of 2014, for example, established a track and trace system meant to ensure the security of the pharmaceutical supply chain and make it harder for adulterated or misbranded drugs to be sold to consumers.
Another law, the Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2010 (SAFE DOSES Act), increased fines and prison time for those found guilty of stealing medical products like pharmaceuticals and medical devices. Persons found guilty of stealing products with the intent to unlawfully distribute those devices can face up to 30 years in prison.
The Counterfeit Drug Enforcement Act of 2014
Tags: Bill, Legislation, Counterfeit, Adulterated, Misbranded, Counterfeit Drug Enforcement Act