Gateway FDA

The Institute of Medicine (IOM) Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries recently issued a report entitled “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad.” This 300-page-long report begins by noting that most of the active ingredients in the medications we take—perhaps up to 80 percent—come from foreign sources, including  low- and middle-income countries with less stringent regulatory requirements than those in place in the United States. Similarly, much of the food we eat comes from other countries, and its safety is also affected by regulatory deficits.

Given the large proportion of foods and drugs that come from foreign sources, Congress has required the Food and Drug Administration (FDA) to conduct more inspections. Weak regulatory systems in developing countries make it difficult for the FDA to monitor product safety, however, since it is only able to inspect a small proportion of foreign manufacturers. 

The IOM was thus commissioned by the FDA to “identify the core elements of food, drug, medical product, and biologics regulatory systems in developing countries; to identify the main gaps in these systems; and to design a strategy the FDA and other stakeholders can use to strengthen food and medical products regulatory systems abroad.” 

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The FDA continues to push its regulatory agenda and priorities primarily through guidance rather than notice and comment rulemaking. This is despite the recent case, Natural Res. Def. Council Inc. v. U.S. Food & Drug Admin., in which the judge seems to challenge the FDA’s preferred practice of ruling by guidance and not through the Administrative Procedure Act. Increasingly, it is critical to be aware of and understand cross-cutting FDA guidance documents, which tend to not only apply to a specific product or process but also provide insight into the FDA’s trajectory in approvals, enforcement, and policy.

For this reason, an awareness of the FDA’s April 6, 2012 guidance, "FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act," is important. Section 513(g) requests have been an available option for devices that do not fall into a neat category for product classification. The drawback has always been the lack of formalized process. In this guidance, the FDA confirms what information can be obtained through a 513(g) request and helps us to better understand the risks and rewards of this process.

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Proper labeling of products regulated by the FDA is extremely crucial. Improper labeling could cost a company millions of dollars (if not billions) in litigation, bad publicity, decrease in stock value, and shareholders’ derivative suits. If managers and executives of regulated companies are not careful, they can  attract personal liability for improper marketing (Park Doctrine).

Labeling of an FDA-regulated product must comply strictly with its ‘intended use,’ as approved by the FDA. If it is not within the strict bounds of the use approved by the FDA, a company can be held liable for promoting a product for non-approved use, or off-label marketing. Often times, the FDA’s investigation of a company for its off-label marketing practices leads to a viral chain of litigation under different laws and theories, including enforcement actions under the False Claims Act and Anti-Kickback Statute, enforcement action by the Federal Trade Commission (FTC), and actions under state laws for improper marketing.

The FDA defines labeling as “labels and all other written, printed, or graphic matter 1) upon any article or any of its containers or wrappers, or 2) accompanying such article.” This definition is interpreted very broadly by the FDA and covers all perceivable marketing and sales promotion. The FDA will look for evidence of intended use in package inserts, directions for use, companies’ websites, sales talks, promotional brochures, practitioner office visits, and trade show displays.

The “practice of medicine exemption” permits only physicians to prescribe or use drugs or devices for different, unapproved uses as part of their practice of medicine. Regulated companies must remain cautious in every interaction and exchange of information with a prescriber. All information on off-label use shared with a physician must comply with good reprint practice, which, among other things, requires that the information be objective and not promotional.

There has been constant case law development in this area affecting the liability exposure of the regulated industry. Any mistake can be fatal. If you are a member of the regulated industry, we recommend, at the very least, formal training of your sales staff; vetting your website claims, including links to other websites and webpages; and drafting, reviewing, and updating your marketing policies and procedures. If avoiding the liability becomes impossible, hopefully the record of the steps you take to prevent improper marketing of your product might help in mitigating the damages.

This week, I had the pleasure of speaking at the MedTech BioVenture Luncheon Series in Rochester, NY, with Zvi Ladin, Ph.D., a principal at Boston MedTech Advisors. My presentation focused on regulatory strategies for medical device manufacturers, classification and predicate assessment, FOIA requests, and identifying when it is most cost-effective to seek regulatory input from attorneys experienced in FDA work and from other sources.

The seminar was well attended by medical device companies, diagnostics and medical device inventors, advisors, and researchers. The presentations led to a very interesting discussion and several helpful suggestions on practical issues faced by the regulated industry.

A prevailing theme in the user fee discussions between the device industry and the FDA has been concerns about review times and unpredictable data requests during the review period.

These concerns are what make the FDA's release of a new standard operating procedure (SOP) in early November so important. The SOP, "Decision Authority for Additional or Changed Data Needs for Premarket Submissions," essentially requires that individual reviewers obtain "concurrence from appropriate management...before taking any action" regarding requesting data that differs from other premarket submissions for the device type or previous communications with a manufacturer.

A few pieces of advice immediately emerge from our reading of this SOP. First, medical device manufacturers should request as much information as possible through Freedom of Information requests early in the review process. This will establish a benchmark of previously required data, giving the submitter some baseline from which to discuss additional data requests with the reviewer should the need arise. 

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