Federal regulators will begin destroying some medications that can't be imported into the U.S. because of quality concerns.
Beginning Oct. 15, the U.S. Food and Drug Administration will destroy a drug that wasn't allowed into the U.S. because it's been found to have been “adulterated, misbranded or unapproved” and in violation of the Food, Drug and Cosmetic Act. The policy covers a drug if the value of a single dose is $2,500 or less.
Currently policy allows for drug imports that do not meet standards for entry to be sent back to the manufacturer, who could resend their products in the hopes that they gain admission.
In a blog posted on the agency's website Tuesday, Dr. Howard Sklamberg, the FDA commissioner for global regulatory operations and policy, and Melinda Plaisier, associate commissioner for regulatory affairs, wrote such drugs pose a public health risk. Often times, denied drugs do not have their active ingredient or have it in improper amounts. Other common problems include products that are found to have the wrong ingredient or contain toxic ingredients.
“This new rule allows FDA to better deter such importation by having an administrative process in place to destroy a refused drug,” Sklamberg and Plaisier wrote.
They added that the new process will allow the agency to focus its limited resources.
Under the new FDA rule, the owner or consignee of a drug that was wasn't allowed into the country would first receive a written notification that their product was going to be destroyed and could appeal the decision before any action took place.
The agency estimates implementation carries a one-time cost of $531,670, with an annual cost thereafter of $54,325. More than 15,000 shipments a year are estimated to be destroyed under the program, which is expected to save more than $901,000 annually.
The plan has received support from the pharmaceutical industry, which worried banned drugs were making their way back to the U.S.
"This constant cycle wasted critical resources that can now be better spent identifying new threats to the legitimate pharmaceutical supply chain," said Mark Grayson, spokesman for the Pharmaceutical Research and Manufacturers of America, in an e-mail.
Close to 40% of the drugs taken by Americans are imported, with nearly 80% of the active ingredients in U.S.-sold drugs coming from overseas.
A growing concern has been the global proliferation of counterfeit drugs that carry labels to look like actual brand-name prescription medications but contain ingredients that in some cases are harmful.
Between 10% and 30% of medicines sold in developing countries are counterfeit, according to the Centers for Disease Control and Prevention. In the U.S., less than 1% of medicines sold are thought to be counterfeit.
Some critics say the rule could limit patient access to drugs from other countries, where prices are often significantly lower.
"The availability of these drugs elsewhere in the world has allowed some of my constituents to afford their other monthly expenses,” wrote Rep. Keith Ellison (D-Minn.,) in a letter sent to the FDA this summer.
