US FDA rule: banned drugs will be destroyed
The rule applies to medicines valued at $2,500 or less, including biologics.
Packages discovered at the border or in the mail can be banned under the Food, Drug, and Cosmetic Act (the FD&C Act) because they contain “adulterated, misbranded, or unapproved” medicines.
Before destroying them, the FDA says it will give the owner or addressee of the package written notice and an opportunity to “introduce testimony” by phone or face-to-face. This person will be liable for storage and disposal costs.
The agency said implementing the rule will “protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.”
Destroying the drugs instead of returning them will prevent the sender from trying to reimport them, the FDA said. It estimated destroying around 15,100 shipments per year.
The agency placed one-off costs for implementing the rule at $531,670.
Additionally, destruction of medicines, updating the FDA Operational and Administrative System for Import Support (OASIS), revising the Regulatory Procedures Manual (RPM), and training staff could cost a maximum of $54,325 annually, or could save up to $901,950, the FDA said.
The rule applies to commercial vendors and members of the public importing drugs for personal use.
Drug shortage?
Plans to implement the rule have been subject to criticism in recent months. Some comments submitted to the FDA during its deliberation period “cited a patient’s inability to comply with a drug treatment plan as a consequence of that lack of access,” the agency revealed.
One comment requested the FDA change its policy to allow personal importation of any drug a “safe” foreign pharmacy or for which there is a “valid” prescription.
But the FDA said the new ruling “does not affect a consumer’s access to a foreign drug” because it affects only drugs refused under the FD&C Act, and US patients have never been allowed access to these.
Another comment suggested the rule could limit the supply of excipients and lead to a drug shortage. The FDA said it does not expect this to happen, and the decision will only affect manufacturers’ access to refused ingredients.
