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January 23 - 25 2015, 12:00 AM - 12:00 AM

ASA PRACTICE MANAGEMENT 2015

February 07 - 08 2015, 12:00 AM - 12:00 AM

ASA Certificate in Business Administration 2015

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Annual Perioperative Surgical Home Summit

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FDA MEDWATCH ALERTS

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

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FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

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FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

October 25, 2014

FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

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FDA MedWatch Intravia Containers by Baxter Recall

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House Energy and Commerce Committee Approves FDA Bill: Enhanced Notification Requirement Includes Manufacturers of Drugs Used by Anesthesiologists

Thursday, May 10, 2012

On Thursday, May 10, 2012, the House Energy and Commerce Committee considered and unanimously approved H.R. 5651, the Prescription Drug User Fee Act (PDUFA) Reauthorization legislation. This bill is tentatively titled "to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes." The reauthorization package would extend the operations of the FDA user fee program for an additional 5 years. The package also contains provisions seeking to address the national shortage of anesthetic and other drugs. Among the key sections of Title IX of the legislation are provisions that would enhance FDA notification requirements on manufacturers whose production of certain drugs is discontinued or interrupted. Such notification would enable FDA to use its existing authority to respond to the reduced production of key drugs in a timely fashion.

Under the current modest voluntary notification requirement, FDA has been able to prevent more than 32 drug shortages in 2012 alone. Other provisions in the title would require the Drug Enforcement Agency (DEA) to provide timely approval or denial to quota changes when it could help address shortages, require the FDA to expedite the approval of manufacturing adjustments that could help prevent or limit drug shortages, authorize GAO to conduct a comprehensive survey about the causes of drug shortages and issue recommendations, and develop interim rules to allow for repackaging of drugs into smaller units by hospitals until the FDA is able to issue guidance on this practice.

Thanks to a concerted lobbying effort by ASA and others, we are pleased that language was included in Title IX that includes manufacturers of anesthetic drugs as part of the enhanced notification provisions. Specifically, the language would require FDA notification for manufacturers of drugs that are "intended for use in the prevention or treatment of a debilitating disease or condition," an important distinction that ASA believes covers drugs used in anesthesia and pain medicine.

As part of the ASA 2012 Legislative Conference May 2 "Lobbying Day," more than 500 anesthesiologists visited Capitol Hill to urge support for drug shortage relief and to highlight the significant impact drug shortages have on the practice of anesthesia, in particular, noting that anesthetic and central nervous systems are the drugs experiencing the highest frequency in shortage.

The legislation is expected to face consideration by the full House of Representatives later this month.

Review the legislation.

 

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