Monday, May 13, 2013

Pediatric drug shortages draw Congressional attention New sterile injectable capacity may help with shortages May 9, 2013 | By Eric Palmer Read more: Pediatric drug shortages draw Congressional attention

The problem of drug shortages in the U.S. is generally discussed in the industry terms of products, plant remediation and FDA approvals. But when the human element is interjected, particularly the effects of drug shortages on infants, it takes a more tragic tone.
That is what senators from both parties hope to do with a letter to the FDA urging it to do whatever is possible to solve drug shortages for pediatric drugs. The letter was sent this week by 14 senators to FDA Commissioner Margaret HamburgRegulatory Focus reports. It says, "Without steady doses of total parenteral nutrition, critically ill infants are at risk of serious negative health outcomes such as painful skin lesions, poor bone health, or vitamin deficiencies. We understand that at least one manufacturer of these products is currently offline and is working with you to get back on the market. We ask that you do everything in your power to get these products back on the market quickly and safely."
The letter does not offer any suggestions on what the FDA might do differently to solve the issue. Much of the national shortage problem can be traced to production disruptions when drugmakers initiate improvements after the FDA has sent them warning letters about problems inspectors found.

Read more: Pediatric drug shortages draw Congressional attention - FiercePharma Manufacturing
Subscribe at FiercePharma Manufacturing

No comments: