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October 2011
Health Law Web Site & Blog!
Please continue to visit the Wolters Kluwer Law & Business Health Law web site and blog: http://health.wolterskluwerlb.com/.
This web site is intended to serve as a community site for the Health Law market with access to a blog written by CCH and industry leading experts, twitter feeds, mobile apps, net news, new product and enhancement announcements, and a knowledge center. Updated daily, the content in the blog will focus attention on topics related to health care compliance, reimbursement, and food and drugs.
Topic of the Month: On October 31, 2011, President Obama signed an executive order to address drug shortages that have worsened in recent years. The executive order requires the FDA to: (1) broaden reporting of potential shortages of certain prescription drugs; (2) speed reviews of applications to begin or alter production of these drugs; and (3) provide more information to the Justice Department about possible instances of collusion or price gouging.
The executive order is the first since 1985 to directly address the FDA and one of a number of smaller measures undertaken throughout the year to improve the agency’s oversight. The administration will additionally send letters to manufacturers reminding them of their legal responsibility to report pending supply disruptions and to encourage them to notify the FDA of events that could possibly lead to disruptions even when not required to do so.
The portion of the executive order that requires the FDA to report to the Justice Department possible instances of price gouging or collusion is largely directed at small wholesalers that buy drugs from one set of users and in times of shortage sell them at huge markups to another.
I. Drugs and Biologics Developments
Orphan drug regulations clarified for “medically plausible” language
The FDA would amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued. Under the proposed rule, to limit the confusion arising from the use of the term “medically plausible” the agency would remove the term from the orphan drug regulations and provide a description of how an appropriate subset may be identified for the purpose of orphan-drug designation.
As described in the current regulations, a drug that is otherwise the same drug as a previously approved drug, and for which a clear showing of greater effectiveness or greater safety has not been made, may still be considered clinically superior within the meaning of the regulations if it makes a major contribution to patient care. Under the proposal, the FDA would find that such clinical superiority is meaningful only when the subsequent drug provides safety or effectiveness comparable to the approved drug. Additional clarifications were proposed by the FDA within the document. FDA Proposal, ¶46,176
PET drug aseptic processing guidance issued to address good manufacturing practice
The FDA published a draft guidance titled “Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs” to help manufacturers of PET drugs meet the requirements for the agency’s current good manufacturing practice regulations. PET drugs are generally designed for parenteral administration and are produced by aseptic processing. The goal of aseptic processing is to make a product that is free of microorganisms and toxic microbial byproducts, most notably bacterial endotoxins. The media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution to test whether the aseptic procedures are adequate to prevent contamination during actual drug production. The draft guidance is a series of questions and answers. FDA Notice, ¶42,147
Qualified audits of software used in electronic controlled substance prescriptions necessary
The Drug Enforcement Administration (DEA) clarified that third-party audits of software applications for Electronic Prescriptions for Controlled Substances (EPCS) must encompass all applicable requirements in federal regulations, including security, and must address “processing integrity_ as set forth in regulations. Specifically, the DEA is clarifying that third-party audits must be conducted by qualified persons. Additionally, the DEA will begin a certification process for EPCS and certifying organizations with a certification process approved by the DEA pursuant to the regulations will be posted on the agency’s web site once approved. If diversion of controlled substances occurs in the EPCS environment, or if controlled substances are otherwise dispensed in violation of the EPCS regulations, responsible parties are subject to administrative or judicial action, including civil injunction. DEA Notice, ¶44,092
II. Food Developments
Bottled water standards for DEHP amended
The bottled water quality standard regulations will be amended in a final rule by the FDA to establish an allowable level for the chemical di(2-ethylhexyl)phthalate (DEHP) to match those levels set by the Environmental Protection Agency. As a consequence, bottled water manufacturers will be required to monitor their finished bottled water products for DEHP at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers also will be required to monitor their source water for DEHP as often as necessary, but at least once every year unless they meet the criteria for source water monitoring exemptions under the CGMP regulations. The FDA has set the allowable level for DEHP in the bottled water quality standard, which includes allowable levels for pesticides and other synthetic organic chemicals, at 0.006 mg/L. The final rule is effective April 16, 2012. FDA Order, ¶40,438
Health Care Compliance & Reimbursement Daily Smart Chart
The Health Care Compliance and Reimbursement Daily Smart Chart is now available for purchase, providing users with daily publication of primary source as it relates to health care topics such as compliance, inpatient hospitals, outpatient hospitals, Medicare Part D, and more…
This tool includes access to Federal Register Issuances, Case Law, CMS Letters and Memorandums, and Administrative Decisions that were officially published earlier the same day. Released around 5pm CST, you will have access to a brief summary of the document, full citation, issuing agency or court, and a link to the full text. Keeping six months worth of documents, you can also use this tool to conduct research on the fly. Additionally, recap news stories from CCH Editorial will be included in this tool summarizing the most important documents of the week or month.
The Health Care Compliance & Reimbursement Daily Smart Chart provides your organization with:
For further information regarding this new product, please go to http://health.wolterskluwerlb.com/