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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Sequester may or may not slow down approvals of generic drugs

Posted in Generic Drugs, Politics

Could go either way.  Probably won’t have any effect on whether or not injured consumers can sue if they took generics.

Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget cuts under the Budget Control Act of 2011–known as sequestration–are scheduled to be implemented at the beginning of March, while legislation funding the federal government expires at the end of March. In September 2012, a report from the White House Office of Management and Budget classified all budgetary resources available to FDA, including user fees, as subject to sequestration (10 PLIR 1332, 10/12/12).

Source: FDA’s Drug Center Creating New Office Of Pharmaceutical Quality, Hamburg Says | Bloomberg BNA