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Congress Considering Oversight of Compounding
Congress is looking at the issue of whether and where to draw the line between state and federal oversight of large-scale compounding pharmacies. Some say that there now appears to be some agreement that the FDA needs some clear authority over compounding manufacturers; those pharmacies that compound very large quantities for interstate shipment in advance of a patient prescription.
However, a hearing before the House Energy and Commerce Health Subcommittee shed more light on the intricacies associated with such regulation. For example, they are unwilling to tighten regulation of the pharmacies due to the importance of the service that the compounders provide to physicians treating patients who don't respond to or cannot tolerate medications mass produced by brand and generic pharmaceutical companies. Concurrently, Congress doesn't want to be seen as allowing poor oversight of large-scale compounders.
http://www.medpagetoday.com/Washington-Watch/FDAGeneral/40523
Compounding Group Formed by Former HHS and FDA Officials
Compounding industry critic and former Health and Human Services Secretary Tommy G. Thompson has teamed up with Sarah Sellers, previously a FDA employee, now working as an industry consultant, to launch the Working Group on Pharmaceutical Safety. This new group is "lobbying senators to toughen" the proposed bill that the Senate Health, Education, Labor and Pensions Committee approved in May to bolster the regulation of compounding pharmacies. Thompson's group "wants senators to ensure that patients receiving compounded drugs have a legitimate medical need for them, such as an allergy to an ingredient in a brand name or generic medicine."
http://www.cq.com/login?jumpto=doc/weeklyreport-4314366
Forty NIH Clinical Trials in India Cancelled by NIH
NIH has stated the "unstable regulatory environment" as the main reason for cancelling almost 40 ongoing clinical trials in India. Clinical trial sponsors have moved the studies to more favorable destinations such as Malaysia and Canada.
http://www.biospectrumasia.com/biospectrum/regulatory/191557/nih-cancels-ongoing-clinical-trials-india#.UeMd6W3YHZM
New Muscle Applied by FDA to Global Drug Supply Chain
The FDA has issued a draft guidance implementing penalties for manufacturers who delay inspections or deny access to inspectors, under new authority granted last year in the FDA Safety and Innovation Act (FDASIA) in order to ensure drug products shipped to and distributed in the U.S. are what they purport to be and not counterfeit. Section VII of the law gives the FDA broad new powers to regulate the global supply chain in an era where 40% of finished products and 80% of active ingredients come from outside the U.S.
http://www.medpagetoday.com/Washington-Watch/FDAGeneral/40431
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