Back in November, the GAVI Alliance added inactivated poliovirus vaccines to the list of products it makes available in the world's poorest countries. And with the conclusion of its tender process, UNICEF is adding its backing: The children's fund has struck a deal with Sanofi to supply the vaccine to GAVI-supported countries for as little as $1 per dose.
Hospitals say the FDA and drugmakers should loop in hospitals and group purchasing organizations to attack drug shortages the way police would attack a hostage situation.
Pfizer last year complicated a shortage of its hypothyroid drug Levoxyl when it tried a new manufacturing process. But manufacturing problems have been ironed out, and the company expects to have the drug back in consumers' hands by next week.
The FDA has taken some tough action against Indian drugmakers like Ranbaxy Laboratories. It has a dozen inspectors stationed in India and will beef that up to 19. But the agency doesn't have it out for Indian drugmakers, FDA Commissioner Margaret Hamburg insists. Its actions there just reflects that India has become one of the biggest links in the global supply chain.
The FDA and other regulators have made it clear they want drugmakers to audit their suppliers to make sure ingredients are safe and sound. The International Pharmaceutical Excipients Council has announced a handful of certifications of companies around the world as suppliers scramble to meet the new expectations.
In much of the undeveloped world, cold-chain delivery of drugs means ice packs, freezers and kerosene-powered generators. Now the World Health Organization has shown that when vaccines are freed from the cold chain, the financial savings and health benefits are enormous.
The explosion in the size of pharma's global supply chain has left the FDA sometimes scrambling to focus its efforts to protect patients from subpar, dangerous and counterfeit drugs and ingredients. In a move to target those players and products that pose the biggest risk, the FDA will give a pass to some companies which don't.
Meningitis A vaccine MenAfriVac has already made its mark on world health, with its nontraditional development model and subsequent success in reducing disease making headlines. Now the World Health Organization is trying to maximize its use by freeing the vaccine from the need to be constantly refrigerated during transport and storage.
A voluntary recall was issued Friday after there was a report of a single visible glass particle in a vial in a lot that was produced for Genco Pharmaceutical Services.
Drug shortages remain a significant health problem in the U.S. and the main cause can still be traced to drugmakers halting production to fix a quality problem. Two reports released last week show that steps by the FDA during the last few years to get on top of the issue have in fact gone a long way to slowing the number of new shortages. Still, that total keeps increasing.