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 Hamburg, Regulatory 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.
However, there have been developments in the sterile injectable part of the industry that may help. Sterile injectables make up a large percentage of those drugs in short supply, and just last month a new sterile injectables plant began producing products. Becton Dickinson ($BDX) got FDA approval for its first sterile injectable drug from its new $100 million plant in North Carolina. Earlier this month, its second drug was approved, and this one, metoclopramide injection, USP, is an injectable antiemetic that has been in short supply.
The FDA is now requiring drugmakers to provide an early heads up if they believe any action they are taking will result in a shortage, and the FDA has been working more closely with other drugmakers to help avoid or relieve shortages. According to the FDA, there were 117 drugs on the shortage list at the end of 2012, less than half of the 251 tallied in 2011. The agency claims that its efforts managed to avoid 282 drug shortages last year.
- read the Regulatory Focus story
- here's the letter
- see the FDA blog post on shortages