India supplies the U.S. with 10% of its drugs and APIs, and some of India's largest drugmakers have felt the sting of FDA citations for quality lapses as the agency steps up inspections there. The Indian drug industry, in turn, gets 90% of its raw materials from China, but it has failed to open an inspection operation there despite that country's reputation for dumping low-quality products on India.
No drugmaker likes to have regulators rain on its parade, but for Indian drugmaker Wockhardt, the bad news is pouring down like a monsoon. The U.K. has stopped most exports from a third plant in four months after finding problems.
Maine's new law allowing citizens to get mail-order drugs from Canada, the U.K., New Zealand and Australia went into effect Wednesday but is being opposed in court by pharmacies and some drugmakers over questions of authenticity.
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 nerve gas attack that killed 1,500 in Syria has put sarin back in the news. But it also has led to attention to manufacturing problems at a Pfizer plant that makes a dual drug antidote injector used by the military and others for such attacks.
Merck's shingles vaccine Zostavax is still reaching too few people, a Duke University associate professor warns.
Walmart, Walgreens and Supervalu are all having their private label brands of the gastroesophageal reflux drug ranitidine hydrochloride pulled off of shelves after Indian generics maker Dr. Reddy's Laboratories found microbial contamination of some of the products.
The drug shortages that continue to plague healthcare providers also continue to provide opportunities for those drugmakers with the drugs that are needed. Jordan's Hikma Pharmaceuticals has again ridden shortages to higher profits, particularly a shortage of the antibiotic doxycycline.
The FDA is seeking 100 volunteers for its Secure Supply Chain Pilot Program that would allow them an easier path for product deliveries if they agree to certain standards.
Recalls are an unwanted expense for drugmakers, and if extensive enough, can be a drag on earnings. For Stericyle, which has a unit that helps companies manage recalls, they have been a moneymaker.