Packaging and Labeling
Celiac sufferer Michael Weber is suing the FDA for dragging its feet on a citizen petition he filed in 2008. The lawsuit attempts to force the FDA to either ban gluten from use in drugs or at least require labels to indicate it is an ingredient in prescription and over-the-counter drugs.
Arena Pharmaceuticals has seen sales of its weight-loss drug Belviq improve since teaming up with marketing partner Eisai. But the two have hit a manufacturing stumbling block, having to voluntarily recall three lots of the drug because of labeling issues.
Indian drugmakers are in a dogfight with Indian regulators who have proposed banning the use of PET plastic bottles for some drug packaging. If they have to move to glass, it will add up to 30% to their transportation cost per bottle, they have complained.
The drugmaker says it disagrees with the U.S. Consumer Product Safety Commission's allegations and is talking things over with the CPSC. But the Department of Justice is also investigating a complaint related to the same matter under the Federal False Claims Act.
After its competitor UPS settled with U.S. authorities over accusations that it was a key link in the supply chain for Internet pharmacies, FedEx vowed to fight any charges that came its way. It will get the chance to do just that after the Justice Department filed charges against the international delivery service.
Another company is having to recall products because of packaging issues which could lead to serious health consequences for patients. This time the mix-up could result in patients getting ibuprofen instead of their scheduled dose of a seizure drug presribed for epilepsy patients.
Federal authorities have torn down another pillar in a wide-ranging business that sourced foreign-made cancer and other drugs and sold them to U.S. doctors at a discount. Some of the meds were cold-chain drugs that were sometimes left unrefrigerated in Pakistan.
The FDA and Department of Justice have taken down another company that brought foreign-made drugs into the country and sold them to physician practices. They say an Illinois man and his company grossed $3 million in three years, selling Allergan's Botox and Juvederm 2 and 3 that were made for the U.K., and 6 countries in the Middle East.
Boehringer Ingelheim is taking steps toward producing medicine in Saudi Arabia for the local market, striking a deal with two Saudi companies, Cigalah and Tabuk, which will manage and handle secondary packaging projects for 26 Boehringer Ingelheim products.
Drug tampering not only poses threats to consumers but is also disruptive and expensive for drugmakers. In the latest case, GlaxoSmithKline sent out an alert Wednesday warning that someone has been altering its over-the-counter weight-loss drug alli.