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By Seth A. Mailhot

On Friday, July 29, 2011, the Institute of Medicine of the National Academies (IOM) released its long awaited report on the premarket clearance process under section 510(k) of the Federal Food Drug and Cosmetic Act.[1] The premarket clearance submission, commonly known as a 510(k), allows manufacturers to market a medical device based on its similarity, or “substantial equivalence,” to one or more marketed devices (called “predicate devices”). The 510(k) process is the most widely used pathway for marketing medical devices through the U.S. Food and Drug Administration (“FDA”), and is intended for intermediate risk devices.[2] The report was anticipated to provide clear action items to the agency to strengthen the 510(k) process and make it more responsive to companies developing emerging medical technology. Instead, the recommendations made by the IOM committee only heighten the current uncertainty with the future direction of the 510(k) process.
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Continue Reading Institute of Medicine Report: Dead on Arrival

By Peter Reichertz

On August 9, 2010, the Food and Drug Administration (“FDA”) published a notice announcing a public meeting to be held September 17, 2010, “to gather stakeholder input on the development of a generic drug user fee program.” See 75 Fed. Reg. 47,820-21. FDA also requested submission of written comments on issues relating to assessment of user fees for generic drugs, which can be submitted by no later than October 17, 2010.
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Continue Reading User Fees for Generic Drugs – What are the Issues?

Last week, the Federal Communications Commission ("FCC") and the Food and Drug Administration ("FDA") launched a joint initiative to clarify the approval process and regulatory requirements for converged communications and health care devices. In a two-day joint meeting held on July 26-27, 2010, the two agencies solicited comments from industry representatives "to gain a better understanding of the convergence of communications technologies and medical devices, the future of wireless health technologies, and the challenges they face." The goal of the initiative is "to enhance coordination between FDA and FCC for future devices and applications, and to clarify and delineate the respective areas of expertise and jurisdiction between the agencies."
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Continue Reading FCC And FDA Focused On Convergence Of Communications And Medical Systems

By Peter S. Reichertz

By letter dated May 27, 2010, the U.S. Trade Representative (“USTR”) sent a letter to the U.S. International Trade Commission (“ITC”) requesting that the ITC provide information about over 700 pharmaceutical products and chemical intermediates for which the elimination of custom duties may be proposed. As part of the “zero-for-zero” initiative of the Uruguay Round Agreements Act, the President can proclaim changes to duties for certain classes of goods as part of the “zero-for-zero” initiative. Pharmaceutical and chemical intermediates are in such categories. To date over 2,000 pharmaceutical products and intermediates have been added to the Pharmaceutical Appendix in the HTUS. The current review is the fourth periodic proposal to add additional pharmaceuticals and intermediates to the list. The United States and 21 other major trading countries agreed during the Uruguay Round to eliminate duties on pharmaceuticals and to periodically conduct reviews to identify additional products to be covered by the initiative. If added to the Appendix, the products included in the new USITC investigation would receive duty-free treatment.…

Continue Reading Elimination of Customs Duties Possible for Over 700 Additional Pharmaceutical Products and Chemical Intermediates

On May 19, 2010, FDA published on its website a series of proposals designed to promote “openness” and “transparency” in government. The document, entitled “FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the United States Food and Drug Administration” can be found here.  The document contains 21 specific proposals about changing the Agency’s policies of disclosure of information submitted to it and about interim decisions made by it.
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Continue Reading The FDA Transparency Initiative: Another One Way Street?

In a Business Review Letter[1] dated April 26, 2010, the U.S. Department of Justice, Antitrust Division (hereinafter, “the Division”) stated that it would not challenge a data sharing program proposed by three health care associations located in California. From the Division’s vantage point, the program posed little risk of facilitating anticompetitive conduct; rather, the most likely effect of the program would be to increase transparency about the relative costs and utilization rates of hospitals that participated in the survey.
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Continue Reading Antitrust Division Will Not Challenge Cost Information Exchange Program in California

A proposed FDA rule would require all “sponsors” (defined broadly) to report not only known falsification of study data but also falsifications merely suspected. The rule, “Reporting Information Regarding Falsification of Data,” defines falsification as “creating, altering, recording, or omitting data in such a way that the data does not represent what actually occurred.” The rule proposes strict timeframes for reporting. The duty to report would be undiminished even where evidence of falsification is slight.
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Continue Reading FDA Proposed Rule: Sponsors Must Report Suspicions of Falsified Study Data

While it is common knowledge that the Food and Drug Administration (“FDA”) is being more active in its review of prescription drug advertising by drug product manufacturers, it may not be widely known that FDA is reviewing what clinical investigators are stating about drugs for which they served as an investigator and which are not yet FDA approved. Recently, FDA posted on its website a Notice of Violation Letter sent January 11, 2010, to Dr. Leslie Baumann of the Baumann Cosmetic and Research Institute. The letter – coded MACMIS #18181 – can be found here.
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Continue Reading Clinical Investigators Beware: FDA is Reviewing What You Say

Manufacturers of liquid supplements and energy drinks appear to be in the FDA crosshairs.

On December 3, 2009, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published a draft guidance, “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.” The guidance took many industry insiders by surprise. Because the guidance is still in draft form, CFSAN has invited comments from stakeholders.…

Continue Reading Shift in FDA’s Regulation of Products Marketed as Dietary Supplements and Functional Foods?

The Food and Drug Administration (FDA) recently launched its Reportable Food Registry (RFR) electronic portal. In conjunction with this launch, FDA has issued a final guidance further discussing the specific requirements.

The RFR requires responsible parties to file a report through the RFR electronic portal at http://rfr.fda.gov when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are deemed by FDA to be “reportable foods.”  A “responsible party” (defined below) must notify FDA of a reportable food within 24 hours of its discovery. These new reporting requirements apply to food and animal feed products.  Infant formula and dietary supplement products are excluded.
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Continue Reading FDA’s New Reportable Food Registry Requirements