On June 27, 2012, the U.S. Senate passed (by a vote of 92-4) the Food and Drug Administration Safety and Innovation Act, a bill primarily designed to let the U.S. Food and Drug Administration (“FDA” or “Agency”) collect user fees from prescription drug and medical device manufacturers to help fund the Agency. The House of Representatives passed the bill on June 20, 2012.
One section of the bill addresses drug shortages and imposes mandatory notification requirements on manufacturers of drugs that are life-supporting, life-sustaining, or intended for use in preventing debilitating diseases or conditions. Specifically, in the event of a “permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the supply of that drug and the United States,” a drug manufacturer must notify FDA at least six months prior to the date of discontinuance with the reasons for the discontinuance or disruption.
Currently, FDA merely encourages manufacturers (that are not sole manufacturers) to report drug shortages and monitors shortages by posting notices on its website.
Under the proposed user fee bill, if a manufacturer fails to comply with the early notification requirements, FDA will send a letter to the manufacturer and require a written response to the letter setting forth the grounds for noncompliance within thirty days. FDA will then make the letters publicly available on its website.
Although the mandatory notification requirement is a step in the right direction, hospitals, patient advocacy groups, and others in the health care industry feel that a monetary penalty, rather than a letter from FDA, is the most effective way to encourage the reporting of drug shortages by drug manufacturers. In fact, earlier this month, several organizations wrote letters to representatives in the House and Senate expressing their desire for civil monetary penalties. However, the monetary penalty was not included in either the House or Senate version of the bill.
The bill is on its way to President Obama’s desk. Track the status of the bill.
What do you think about the new mandatory notification requirement for drug manufacturers? Should the bill have included monetary penalties for a failure to notify? Or do you think FDA’s current monitoring of drug shortages is sufficient? Sound off below!