Originally Published MDDI July 2005
New Pedigree Drug Laws May Snag Device Makers
Laws meant to prevent drug counterfeiting may mean more requirements for device manufacturers.
Medical device manufacturers may be the unwitting recipients of new regulatory requirements because of impending pharmaceutical laws.
To curb the rise in drug counterfeiting, a number of states from Florida to California have drafted legislation that requires pedigree laws for prescription drugs. These laws mandate the tracking of a pharmaceutical product throughout the supply chain. For device manufacturers whose kits include a drug, this tracking requirement could mean implementing tracking software or some other method to ensure they are meeting the requirements of each state. Three states—Florida, Nevada, and California—already have laws set to take effect. “There are many device manufacturers with convenience kits, so this could have a wide-reaching effect in the industry,” says Steve Lawrence, a partner with Hogan & Hartson (Irvine, CA). “It could be a mess.”
The pedigree document is initiated by the pharmaceutical manufacturer, but as the distributor, the device firm would have tracking responsibilities as the drug comes into and leaves its facilities. Pedigrees must be authenticated by each wholesaler recipient prior to receiving the drugs, according to Lucy Deus of SupplyScape Corp., a manufacturer of pedigree software. The wholesaler must then sign an outgoing pedigree before sending it to the next distributor or final customer.
“I would certainly recommend that device manufacturers find out what's going on in their state,” says Steve Lawrence. “They should talk with their legislators to find out how these laws are going to affect them. They should also contact their national trade associations.”
Florida's law, for example, states, “...each person who is engaged in the wholesale distribution of a prescription drug and who is not the manufacturer of that drug must ... provide to the person who receives the drug a pedigree paper.... A repackager must comply with this paragraph.”
According to Deus, a pedigree is considered a “document of record” for the receiving organization, and thus is subject to recordkeeping, record retention, and record availability requirements.
Depending on how each state decides to interpret and define manufacturer and wholesaler or repackager, the pedigree laws could reach even farther, affecting the distribution of drug-eluting stents as well, Lawrence says. “This could be an unintended consequence,” he cautions.
Nevada is the only state with a pedigree law currently in effect. However, Florida's statute is slated to become effective July 1, 2006, and California's is scheduled to be in effect January 1, 2007. California is the first to require that the tracking system be electronic. Other states discussing legislation include: Arizona, Arkansas, Illinois, Indiana, Iowa, Kansas, Maryland, Missouri, Nebraska, New Jersey, Oklahoma, Oregon, Texas, Utah, and Virginia.
FDA's pedigree law, written in 1988, has been postponed repeatedly and is currently stayed until December 2006.
Lawrence says it may be too early to tell how the new regulations will ultimately affect device manufacturers. “Perhaps if they swing into action now, they can have some effect on the implementation of these new laws,” he says.
Sherrie Conroy for The Editors
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