drug shortageIntroduction

Drug shortages are a serious concern in today’s world, costing hospitals at least $200 million annually and putting patients at risk of medication errors. The number of reported drug shortages has tripled from 61 in 2005 to 178 in 2010. Many commonly used medications are becoming more and more scarce. The reasons for shortages are complex and include increased demands, manufacturing capacities, shipping delays, and ingredient shortages.

In 2011, S296: Preserving Access to Life-Saving Medications Act was introduced. If passed, this act will give the FDA the power to mandate early disclosure of prescription drug shortages. In response to President Obama’s Executive Order of Oct. 31, 2011, the Obama administration issued an Interim Final Court Rule that was built on the FDA’s current work to ensure that Americans would have access to the medications they need. In 2012, a draft guidance was released by the FDA to help guide the notification process. However, the Interim Final Court Rule only applied to sole manufacturers of a prescription drug product approved under 505(b) or 505(j) and products that are “life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition.” The reporting process for all other drugs remains voluntary.

Background

Despite the FDA’s continuous effort to prevent and address issues with drug shortages, the issue seems to be more complex. According to the FDA’s recent review of published and unpublished information on drug shortages, the cause of the problem stems from economic, legal, regulatory, policy, and clinical decisions that are deeply interconnected. The FDA states that many potential solutions to drug shortages will require collaborative efforts from all relevant stakeholders. Since a solution at the present time is no longer an option, prevention becomes the next best thing.

Issue

Should the FDA have the power to mandate early disclosure of prescription drug shortages?

Rule

The FDA should be given the power to mandate early disclosure of prescription drug shortages if all of the following are true:

1)      The FDA has successfully prevented drug shortages in the past due to information from early disclosure.

2)      The power to enforce disclosure is essential for the FDA to successfully prevent drug shortages.

3)      There are no other agencies with the authority to address the issue of early disclosure in preventing drug shortages.

Analysis

1)      According to official data from the White House, the FDA successfully prevented 99 drug shortages in 2011 due to voluntary early notification by manufacturers. Once the FDA receives the notification, it can carry out one of the following options to prevent an actual drug shortage: (1) ask other firms to increase production, (2) work with manufacturers to identify ways to mitigate quality issues, or (3) expedite the review process for regulatory submissions.

2)      According to the U.S. Department of Health and Human Services, “early notification of potential drug shortages is an essential tool in helping the FDA work with drug manufacturers, hospitals, doctors, and patients to prevent or mitigate a drug shortage before it becomes a crisis.”

3)      According to the Interim Final Court Rule issued by the Obama administration, manufacturers must report any temporary delays, discontinuation, or manufacturer shut-downs to the FDA 6 months in advance.

Conclusion

The FDA should be given the power to mandate early notification because it is the only agency in the country with the authority to address issues in preventing drug shortages. It has demonstrated successful prevention of drug shortages in the past through early disclosure, and this power is necessary for the FDA to continue to prevent drug shortages.

For more information on this issue, contact the Kulkarni Law Firm.