FDA Update: January 2012 — Drug Shortages; Ranbaxy, FDA Agreement

By Lori Clapper, Editor

Drug Shortages No More?
On December 15, The FDA issued an interim final rule to help prevent prescription drug shortages. The agency now requires pharmaceutical manufacturers to report all production interruptions of drugs that are life supporting or life sustaining, or that prevent a debilitating condition.

President Obama's October 31 executive order challenged the FDA and the Department of Justice to reduce drug shortages. It also granted the FDA power to enforce new requirements. On the same day, the FDA sent a letter to pharmaceutical manufacturers that stressed the importance of reporting potential shortages.

The FDA prevented 96 drug shortages since the executive order was issued, according to the U.S. Department of Health and Human Services.

Find out who reported drug shortages last month.

Ranbaxy, FDA Reach Settlement
Ranbaxy Laboratories and the FDA reached a settlement to lift a ban on drug imports into the United States. The Indian pharmaceutical company announced last month it will "further strengthen procedures and policies to comply with current good manufacturing practices." According to the Economic Times, the consent decree is up for approval in the U.S. District Court for the District of Maryland. Ranbaxy could also shell out up to $500 million in liability fines related to a U.S. Department of Justice (DOJ) investigation. In 2008, the DOJ alleged Ranbaxy lied about drug formulations and ingredients, according to an Associated Press report in BusinessWeek. The company believes this amount will be "sufficient to resolve all potential civil and criminal liability" connected to this case.