Posted May 15, 2013
Federal employees will be able to seize and hold adulterated or misbranded pharmaceuticals once pending regulations are enacted, the Food and Drug Administration recently announced.
Legislation passed in July 2012 gives the agency authority to detain such unsafe drugs, as it already can do with similarly unsafe foods for human or animal consumption, medical devices, or tobacco products, according to an April 9, 2013, Federal Register notice and other agency announcements.
FDA spokeswoman Siobhan DeLancey said the authority described in the April 9 notice will be particularly useful for investigations involving human-use drugs, such as those sold as dietary supplements, but also will apply to veterinary drugs. Counterfeiting human drugs and marketing pharmaceutical-containing foods as supplements are both big businesses, she said.
If FDA inspectors suspect drugs are adulterated or misbranded, they will be able to order detention of those products. If they confirm those suspicions, the agency can issue warning letters, seize products, seek injunctions, and prosecute people according to the severity of the violation, the likelihood of harm, and the record of previous violations, DeLancey said.
The need for the new authority had been described in congressional testimony.
In September 2011, Deborah M. Autor, deputy commissioner for global regulatory operations and policy for the FDA, testified before the U.S. Senate Committee on Health, Education, Labor, and Pensions that new regulatory authorities could help ensure the security and integrity of pharmaceutical supply chains and quality control systems. In a written statement, which is available at www.fda.gov/newsevents/testimony, she said the FDA had authority to administratively detain illegal foods and medical devices in U.S. commerce, but no similar authority for drugs.
“Currently, we cannot immediately detain dangerous drug products when we find them,” Autor said. “Absent this immediate tool, consumers can be exposed to unnecessary risks.”
The April 9 FDA Federal Register notice is available at www.regulations.gov under docket number FDA-2013-N-0365.