May 01, 2008U.S. House Representatives Steve Buyer (R-Ind.) and Jim Matheson (D-Utah) joined a hearing of the House Committee on Energy and Commerce today to glean support for a bill that would mandate the U.S. Food and Drug Administration (FDA) to generate a unified track-and-trace pedigree standard for pharmaceuticals as they traverse the supply chain. The sponsors hope their bill, the Safeguarding Pharmaceuticals Act of 2008 (HR 5839), will be included in the Food and Drug Administration Globalization Act—broader legislation the committee is currently reviewing and preparing to present to the House of Representatives.
HR 5839 reads similarly to the Food and Drug Administration Amendment Act (FDAAA) that passed in 2007, dictating that the FDA must specify a recommendation for drug identification by the end of March 2010. HR 5839 takes this a step further, however, requiring that the FDA issue a track-and-trace recommendation by the same date that spells out the technology to be used for a unified pedigree system.
With HR 5839, the FDA would also propose a list of high-risk pharmaceuticals that must be tracked most urgently, then require the manufacturers of such drugs to comply with the FDA recommendation for a pedigree solution within 18 months after the agency makes its choice in March 2010. The bill cites RFID as one technology that could be employed in an electronic pedigree (e-pedigree) system. However, says Congressman Matheson's communications director, Alyson Heyrend, the bill is intended to be technology-neutral.
Matheson, Heyrend says, "is concerned with the hodgepodge of efforts state by state for a pedigree system." The hope with this bill, she notes, is to mandate the FDA to create a single uniform national standard rather than allow each state to develop its own standard. "Obviously," she says, "he thinks this bill is the way to go with those key concerns." While the FDAAA requirement also puts the standardization in the hands of the FDA, it does not specifically require the track-and-trace technology to be standardized.
In addition, HR 5839 would enable the FDA to destroy any pharmaceuticals proven to be counterfeit or misbranded, or that were tampered with or diverted at some point in the supply chain. Such tampering could be identified, for instance, at the port of entry into the United States. At the committee hearing, Ilisa Bernstein, the FDA's senior advisor for regulator policy, told Buyer that in such cases, the FDA currently sends a letter of detention to the receiving party of the questionable pharmaceuticals, giving that party 20 days to respond.
If the FDA does not receive a response, that agency—or U.S. Customers and Border Protection (CBP) in the case of products seized as they enter the country—then either returns the drugs to the sender, or keeps them on a shelf for 90 days before destroying them. With the new measure, the FDA or CBP would be allowed to simply go to the site where the questionable pharmaceuticals are being held and destroy them immediately. Bernstein told Buyer that "streamlining the destruction authority would certainly be beneficial."
Last month, California extended the deadline for an e-pedigree system in its state (see All Eyes on FDA for Drug Pedigree) from 2009 to 2011, because the pharmaceutical industry indicated it would not be able to meet the earlier deadline.
At today's hearing, Buyer inquired about FDA support of a unified pedigree system, to which Bernstein responded that "a pedigree system provides transparency and accountability through the supply chain. That helps not only ensure [consumers receive] a safe product, but allows regulators to trace back through the supply chain." The FDA, she added, supports one uniform national standard but does not specify a specific track-and-trace standard, nor does it recommend a specific technology.
Inquiring whether technology had evolved enough to provide affordable pedigree solutions, Matheson asked, "Where is the technology now?" To this, Bernstein replied that "There has been tremendous progress on technology and standards" in the past four years.
A spokesperson for Buyer, who asked not to be named, said the congressman was concerned about the selling of pharmaceuticals via the Internet—one way in which counterfeit drugs may be entering the country from international markets. By requiring that drug manufacturers follow a standardized track-and-trace method, the spokesperson indicated, that problem could be alleviated.
