A bipartisan group of U.S. senators have proposed a new bill that would create a national drug tracking system to fight stolen, counterfeit and potentially harmful drugs.
The proposed bill (PDF) was put forward by Senator Tom Harkin, chairman of the Senate Committee on Health, Education, Labor and Pensions, as well as Ranking Member Senator Lamar Alexander and Senators Michael Bennett and Richard Burr. The bipartisan group said the plan would improve and strengthen the nation’s drug supply chain.
“Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug store shelves,” Bennett said in a press release. “In fact, right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills, which could mean the difference between life and death.”
The bill would call 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.
“Ensuring the integrity and security of our prescription drug distribution system is critically important,” Harkin said in the press release. “To ensure consumers know that the medications they take are safe — not adulterated, counterfeit, or otherwise compromised, it is important to know where these drugs have been at every step of the way — from the manufacturer to the pharmacy.”
Heparin, Avastin Incidents Showed Supply Chain Problems
The system is designed to prevent events like the 2008 contaminated heparin incident, which has been blamed for 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.
It 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.