Legislation Introduced in February Could Help Ease U.S. Drug Shortages

By Anonymous | Drug Topics, March 2011 | Go to article overview

Legislation Introduced in February Could Help Ease U.S. Drug Shortages


Anonymous, Drug Topics


From staff reports

The American Society of HealthSystem Pharmacists (ASHP) and 3 other healthcare industry groups are working to transform regulations to ease U.S. drug shortages.

In January, representatives from ASHg the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the American Hospital Association (AHA) met with aides to U.S. Sen, Amy Klobuchar (D -Minn) to discuss key points from the groups' November Drug Shortages Summit that should be induded in federal legislation.

The result was the introduction of S. 296, The Preserving Access to life-Saving Medicines Act, on February 7, sponsored by US, Senators Klobuchar and Bob Casey (D-Pa,), The bill would increase the authority of FDA to prevent dmg shortages.

"Senator Klobuchar's office was interested in working with us as a group on this issue. We told her our desire to move forward as a group and [to] try to achieve consensus from all parüdpants in the supply chain, induding manufacturers and distributors," said Cynthia Reilly BS Pharm, director of ASHP's Practice Development Division.

The recommendations

The group suggested several options that could be induded in new legislation, induding a requirement for advance notification of supply or production problems by both single -source and multisource manufacturers; changes to FDA regulations for reporting interruptions in single-source, medically necessary product supplies at least 12 months in advance of planned action; and revision of FDA's definition of "medically necessary" to allow for indusion of factors on the impact of medication use.

Among the key items in the S.296 Act:

* The drug manufacturer will be required to notify the Secretary of Health and Human Services (HHS) of a discontinuance, interruption, or other adjustment of the manufacture of a drug that would result in a shortage of that drug. The notification should occur at least 6 months before the date of the discontinuance or planned interruption or adjustment.

* The types of adjustments that a manufacturer shall submit as notification indude adjustments related to raw materials (induding active pharmaceutical ingredients), adjustments to production capabilities, and business decisions that affect the manufacture of the drug. …

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