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April 12, 2013


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The recent paper of Woodcock and Wosinska represents FDA's limits in regulating a public health and safety emergency for our patients. They are laying the problem of drug reimbusement finitude at the doorstep of Congress and the President who are soon going to face the joint ire of patients and their doctors as a new science of declining patient safety, quality outcomes decline and secondary economic inefficiency in the American Hospital system is made public. Whether one is in Oncology, Anesthesiology, nutrional support, infectious disease, emergency medicine or Critical Care, our abilities to serve as lawful fiduciaries of our patients under the common laws of the states is threatened by publically dangerous and unsustainable reimbursement federal laws and regulations.

Physicians Against Drug Shortages (See our recent comments to the FDASIA Act of 2012 on FDA website) believes in a predominately unitary economic theory of causation of all the generic injectable drugs and rejects the primacy of the multifactorial causes proposed in the 2011 FDA Drug Summit.

Congress created the root cause when it passed the 1987 Anti kickback exemptions from criminal prosections asked for by the hospital industry. Several GAO reports as recently as March 2012 document that regulators with subpoena powers (OIG, DOJ antitrust division or FTC) have not conducted financial audits of the market middlemen (group purchasing organizations) for what is an unaccountable 300 billion dollar market.Those investigations are necessary and the President ought to insit that Secretaries Sebelius and Holder carry out their oversight powers as a matter of patient safety and welfare. Theories are just that and Americans expect data transparency on this issue as they come to understand it.

Declining obective medical outcomes will not be favorable to any public elected officials future careers. The National Quality Forum needs to recognize Drug Shortages as anew negative quality and efficiency marker and give birth to a new form of system risk management. If Americans want new innovation, our financial constraints as a nation require that we maximize the manufacture and distribution of proven cheap effective mainstays of standard of care medicine.

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