Bill to Create Drug Tracking System Passes House
Lawmakers moved closer this week to creating a new program that will track all drug prescriptions in the United States, hoping to reduce the risks associated with stolen or counterfeit drugs.
On Monday, the U.S. House of Representatives passed a “track and trace” bill, which many believe will help protect the country’s drug supply chain.
A similar bill is in the works in the Senate, but that bill, S. 957 (pdf), would require more of a technology investment. It has been passed by committee but has not yet been brought to the senate floor.
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The new legislation calls for drugs to be traced by individual units, instead of lots; a change that would be phased in over the next 10 years. The bill would require every part of the supply chain, from manufacture on down, to pass on transaction information every time the drug changes hands. If the information is not provided, the next step in the supply chain would not be allowed to accept the drug.
Drug makers have opposed the legislation, arguing that it could be too expensive. Some House Democrats opposed the House version of the bill, which they said was watered down and less effective than the senate version.
The proposed “track and trace” system is designed to prevent events like the 2008 contaminated heparin incident, which has been blamed for the deaths of nearly 150 people. Contaminated batches of the drug came from a Chinese supplier and made its way into U.S. pharmacies and hospitals.
The 2008 contaminated heparin came to the United States through Baxter International, Inc., and the resulting heparin recall, issued in January 2008, affected more than half of the supply of the drug in the United States. The contaminated heparin also surfaced in at least 10 other countries, FDA officials say.
The proposed drug tracking system also may have also been effective in preventing the entry of counterfeit Avastin into the nation’s supply chain in 2012. The potentially dangerous counterfeit vials were sold by a foreign supplier that calls itself either Quality Specialty Products (QSP) or Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor for the company. It did not contain the active ingredient bevacizumab and the FDA said it was neither safe nor effective.
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