The Drug Quality and Security Act, approved by the Senate Monday and now awaiting the president's signature, lays out limited FDA powers to oversee the compounding pharmacy industry and kicks off the process of establishing a so-called national track-and-trace system
A longtime goal of the FDA is for the industry to put in place a national system that would allow it to follow a drug product from manufacturer to pharmacy. After years of back-and-forth with the industry about how that would be done, it is about to get started.
Pfizer and the FDA are often confronted with counterfeit of the erectile dysfunction drug Viagra that may not contain an active pharmaceutical ingredient. Now FDA is warning men they may have a counterfeit drug supplement that does contain the active ingredient in the little blue pill. And it could kill them.
The feds have taken another drug dealer off the streets. This one sold more than $7 million worth of unapproved foreign cancer drugs from Turkey, Pakistan, India, and elsewhere to oncologists who were administering them to their patients.
The spectacular, $90 million burglary of a warehouse full of Eli Lilly drugs in 2010 continues to be in the news as some of the two dozen suspects get charged or convicted.
Contract manufacturer IDT Biologika and Oncotec Pharma Produktion are putting a combined €70 million into plants at IDT's BioPharmaPark in Dessau-Roβlau, Germany. IDT will invest €40 million in its vaccine and parenteral sterile fill-and-finish capacities.
Counterfeiters often pump out fakes of Pfizer's ED drug Viagra, but they also like its anxiety drug Xanax. Proof of that came last week when Swissmedic discovered 1 million counterfeit Xanax pills on a jet headed from China to Egypt.
Track-and-trace, the ability to follow a drug product from manufacturer to pharmacy, has been a longtime goal of the FDA. The agency believes it would help foil drug counterfeiting and expedite recalls for any reason. Drugmakers have said they thought it was a good idea but were reluctant to commit to a date certain since the system requires investments and coordination from every link in the supply chain. Now, a bill poised for passage has put a timeline to it: 10 years to have all the pieces in place and the system operational.
The arrest came after the State Administration of Ukraine on Medical Products (SAUMP) found nearly 4 million packages of counterfeit and unlicensed products worth an estimated $37 million at a supplier's facility.
The Department of Justice has indicted two men it says brought in thousands of counterfeit and misbranded Viagra tablets from China.