Federal authorities were interested in the way Shire was pushing many of its drugs and the company has now disclosed that an agreement is close. It said it will take a $57.5 million charge to its fourth-quarter earnings to settle up for its missteps.
Unable to police all of the sites out there selling drugs directly to consumers, the FDA is trying something new, a campaign it hopes will discourage the practice, or at least, teach consumers how to determine what sites are potentially legit.
Even as efforts are made to buttress protections against counterfeit drugs, state officials in Maine, including the governor, are working to change the state's legislation so its public employee health programs can keep buying drugs from a Canadian Internet pharmacy.
With fake Avastin having made its way into the U.S. through a Canadian pharmacy, the FDA has stepped up investigations into the practices of some of the cross-border operations. That doesn't phase the governor of Maine who is looking for a legislative fix to allow a state employee program to keep buying drugs from one.
With the approval in Canada last week of its foot ulcer treatment Dermagraft, Shire may be needing its new manufacturing capacity in La Jolla, CA, sooner rather than later.
The market is showing its own hypersensitivity to the ongoing onslaught of generics on the the world's best-selling drugs.
Shire's Adderall XR just took a torpedo to the keel. U.S. regulators have approved the first third-party rival to the big-selling ADHD drug. The agency thus ushers onto the market a lower-priced rival from Actavis more than a year earlier than expected.
With counterfeit drugs having moved from fake erectile dysfunction medications to ADHD drugs and lifesaving cancer meds, federal authorities have got to be feeling pressure to put its resolve into action. So they have rounded up one of the early operators of a Canadian Internet pharmacy on charges tied selling counterfeit drugs for about 18 months 6 years ago.
The European Union is embarking on a track and trace system to try to foil counterfeiters, which when implemented in 2014, will include unique identifiers on each individual package of drugs. The process will be closely watched in the U.S. where a similar system could end up in the pending FDA reauthorization legislation.
The short-acting form of Adderall has been in short supply since last year due to "active pharmaceutical ingredient supply issues."