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August 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 Institute of Medicine (IOM), an influential body that advises the federal government on science policy, proposed in August that the FDA scrap the process it uses to clear many medical devices for use because the current method could not ensure the safety and effectiveness of the medical devices. According to the 280-page IOM report, the FDA should require more extensive testing of thousands of “moderate-risk devices” — from wheelchairs to artificial hips — that come to market with little study because manufacturers can argue that the devices are “substantially equivalent” to products already in use.
The report was issued just as device makers have been urging the FDA to streamline the approvals system. A group of manufacturers had also been campaigning to undermine the report before it was published, saying the 12-member panel of physicians, lawyers and policy experts did not represent all points of view.
A new framework to make sure these devices are safe and effective without stifling innovation that could improve patient health would take some time to test and implement. It will be interesting in the aftermath of the IOM report whether a consensus framework that would satisfy both the business demands of medical device manufacturers’ bottom line to have products to market as soon as possible and keep the public satisfied as to the regulatory function of the FDA could be devised.
I. Food Developments
Foreign and domestic facility reinspection fee rates established for FY 2012
For the first time, fiscal year (FY) 2012 fee rates for certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections were published by the FDA. These fees are mandated in the FDC Act as recently amended by the FDA Food Safety Modernization Act. These fees are effective on October 1, 2011, and will remain in effect through September 30, 2012. Invoices for these fees for FY 2012 will be issued using the fee schedule established in this document. The fees cover three types of activities and fore each one the fee established is intended to capture 100 percent of the costs of each activity for each year.
The fee is based on the number of direct hours spent on taking action in response to the firm’s failure to comply with a recall order. Types of activities could include conducting recall audit checks, reviewing periodic status reports, analyzing the status reports and the results of the audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition. The direct hours spent on each such recall will be billed at $224 an hour if no foreign travel is required and $335 an hour if foreign travel is necessary. These fees are effective on October 1, 2011, and will remain in effect through September 30, 2012. FDA Notice, ¶44,054
II. Drugs and Biologics Developments
Bronchodilator products relabeled to add warnings
The final monograph (FM) for over-the-counter (OTC) bronchodilator drug products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride will be amended to add additional warnings and to revise the indications, warnings, and directions in the labeling of these products under an FDA final order. The final rule, issued under the FDA’s continued review of OTC drug products, will help consumers understand how to use these products and when it is appropriate to seek treatment from a doctor for their asthma. Language on the warning labels for these products has been revised so it is more readily understood by the average consumer. The estimated one-time relabeling cost ranges from $0.75 million to $4.1 million. FDA Order, ¶40,434
Medical Imaging Drugs Advisory Committee reestablished
Effective August 5, 2011, the FDA will re-establish the Medical Imaging Drugs Advisory Committee in the FDA’s Center for Drug Evaluation and Research. The committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology. The committee will be composed of a core of 12 voting members selected by the agency from among authorities knowledgeable in the fields of nuclear medicine, radiology, epidemiology or statistics, and related specialties. FDA Order, ¶40,435
Human research subject protections and modernizations proposed
An advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective was published by the FDA. The agency is seeking comments to assist in better protecting human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. Revisions to the current regulations are being considered due to the volume of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics.
The current system has been criticized for not adequately calibrating the review process to the risk of research, as well as issues regarding the extent and quality of the protections afforded by current informed consent requirements and practices. Finally, the increasing use of genetic information, existing (i.e., stored) biospecimens, medical records, and administrative claims data in research has changed the nature of the risks and benefits of research participation. Questions to consider include: (1) should some threshold for radiological exams performed for research purposes, that is calibrated to this background level of exposure, be identified as involving no more than minimal risk; and (2) how frequently should a mandatory review and update of the list of research activities that can qualify for expedited review take place. Written or electronic comments are due by September 26, 2011. FDA Advanced Notice of Proposed Rulemaking, ¶46,174
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/
III. Medical Devices Developments
FDA to exert authority over specific mobile medical applications
The FDA published a draft guidance titled “Procedures for Handling Section 522 Postmarket Surveillance Studies” to provide recommendations and assist device manufacturers subject to a section 522 postmarket surveillance order imposed by FDA. The draft guidance provides an overview of FDC Act §522 and procedural information on how to fulfill section 522 obligations, namely recommendations on the format, content, and review of postmarket surveillance study submissions. FDA Notice, ¶19,595