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September 2011
Introducing the New Health Law Web Site & Blog!
Wolters Kluwer Law & Business is proud to announce a new 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: The FDA recently posted a public service message on its website reminding consumers that labels for most packaged foods marketed in the U.S. must disclose in simple-to-understand terms when they are made with a “major food allergen.” Rhonda Kane, a registered dietitian and consumer safety officer at the FDA, recommended that consumers "first look for the ‘Contains’ statement and if [the] allergen is listed, put the product back on the shelf.” Even if the "no Contains" statement is present, Kane stated that it was "very important to read the entire ingredient list to see if [the] allergen is present. If you see its name even once, it’s back to the shelf for that food too."
"Organic" and "natural" is also increasingly the subject of litigation as well. The U.S. Department of Agriculture's (USDA) organic seal indicates that a multi-ingredient product contains at least 95% organic ingredients; however, this certification process is entirely voluntary. Natural is a term bandied about in foods, but general applicability is via USDA regulation in the meat and poultry industry. For other food articles, the FDA's definition of “natural” is “that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.” Consumers must be ever careful of purchasing items advertising the latest health fad with buzzwords.
I. Drugs and Biologics Developments
Non-face-to-face tobacco sales information sought
An advance notice of proposed rulemaking in order to obtain information related to the regulation of non-face-to-face sale and distribution of tobacco products and the advertising, promotion, and marketing of tobacco products was published by the FDA. The advanced notice is part of the FDA’s implementation of the Family Smoking Prevention and Tobacco Control
Act. The FDA is requesting comments, data, research, or other information related to non-face-to-face sale and distribution of tobacco products; the advertising, promotion, and marketing of such products; and the advertising of tobacco products via the Internet, e-mail, direct mail, telephone, smart phones, and other communication technologies that can be directed to specific recipients. The FDA is seeking answers to a variety of questions including: (1) what are the methods used by minors to acquire tobacco products through a non-face-to-face exchange;
(2) which of these methods are minors most successful in using to obtain tobacco products; and (3) what means are used to deliver tobacco products sold to consumers through non-face-to-face exchanges. FDA Proposal, ¶46,175
Foreign drug facility inspections hampered by lack of information
In 2008, GAO reported that FDA databases contained incorrect information about foreign establishments and did not contain an accurate count of foreign establishments manufacturing drugs for the U.S. market. The FDA’s lack of information hampered its ability to inspect foreign establishments, and the GAO recommended that FDA address these deficiencies. According to the GAO report, the FDA had undertaken steps to address the deficiencies, but noted that the FDA needed to act quickly to implement changes across a range of activities in order to better assure the safety and availability of drugs for the U.S. market. The FDA acknowledged that it was far from achieving foreign drug inspection rates comparable to domestic inspection rates — the agency inspected 1,015 domestic establishments in fiscal year 2009. Also, the types of inspections the FDA conducted generally did not include all parts of the drug supply chain. The FDA identified statutory changes that will help improve its oversight of drugs manufactured in foreign establishments, noting that in place of the current requirement that it inspect domestic establishments every 2 years, the agency would benefit from a risk-based inspection process with flexibility to determine the frequency with which both foreign and domestic establishments are inspected. GAO Report, No. 11-936T , ¶101,248
Draft guidance on warning plans for smokeless tobacco products issued
A draft guidance to assist persons submitting warning plans to the FDA under the Comprehensive Smokeless Tobacco Health Education Act, as amended by the Family Smoking Prevention and Tobacco Control Act; and under the Federal Cigarette Labeling and Advertising Act, as amended by the Family Smoking Prevention and Tobacco Control Act, when that requirement takes effect was published by the FDA. Titled “Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products” the draft guidance will provide the industry with information on how to submit warning plans for smokeless tobacco products. The guidance document discusses, among other things: (1) the statutory requirement to submit a warning plan; (2) definitions; who submits a warning plan; the scope of a warning plan; (3) when to submit a warning plan; (4) what information should be submitted in a warning plan; (5) where to submit a warning plan; and (6) what approval of a warning plan means. FDA Notice, ¶42,133
Scored tablet nomenclature and scoring criteria draft guidance published
A draft guidance that provides recommendations to sponsors of new drug applications and abbreviated new drug applications regarding what criteria should be met to facilitate the evaluation and labeling of tablets that have been scored, was published by the FDA. Titled “Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation” the draft guidance provides guidelines to follow, data to provide, and criteria to meet and detail in an application to approve a scored tablet; and nomenclature and labeling for approved scored tablets. Scored tablets or tablets with a scoring feature are made to facilitate tablet splitting, the practice of breaking or cutting a higher-strength tablet into smaller portions. The guidance does not address specific finished-product release testing, where additional requirements may be appropriate for scored tablets. The draft guidance provides criteria by which scored tablets can be evaluated and labeled. The criteria are as follows: (1) provide a harmonized approach to chemistry, manufacturing, and controls reviews of scored tablets; (2) ensure consistency in nomenclature (e.g., score versus bisect) and labeling; and (3) provide information through product labeling or other means to healthcare providers FDA Notice, ¶42,130
Introducing the New 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/