Summary

Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has taken a number of actions that could impact nearly all of the industries it regulates, but in particular, companies in the medical device and food spaces.  These actions include:

• changing Institutional Review Board (IRB) oversight of certain medical device clinical trials;
• extending unique device identification system (UDI system) compliance dates for certain class I and unclassified medical devices; and
• reorganizing the Agency’s Office of Regulatory Affairs (ORA), which should result in the food industry experiencing more uniform and consistent application of FDA’s inspectional approach.

And just yesterday, Center for Science in the Public Interest (CSPI) and National Consumers League (NCL) sued the Agency  over its decision to delay the compliance deadline of a rule requiring chain restaurants and similar retail food establishments to disclose calorie and nutrition information (Menu Labeling Rule or the Rule).

FDA Sued Over Menu Labeling Rule Delay

On June 7, 2017, CSPI and NCL filed suit against FDA in the U.S. District Court for the District of Columbia over the Agency’s recent decision to delay the Menu Labeling Rule compliance deadline.  As we have discussed previously (here, here, here, and here), the Menu Labeling Rule  requires restaurants and “similar retail food establishments” (e.g., convenience stores and grocery stores) that are part of a chain of 20 or more locations and that sell similar menu items to post on menus and menu boards: (1) calorie information; (2) a statement on suggested daily caloric intake; and (3) a statement that written nutrition information is available upon request (and provide such information upon request).

As some will recall, just a few days before the Rule was set to go live, the Agency released an interim final rule that delays the Rule until May 7, 2018. In their complaint, CPSI and NCL request that the court vacate FDA’s interim final rule delaying the Menu Labeling Rule and declare compliance with the Rule to be required within 15 days after the court issues its order.

FDA’s delay of the Menu Labeling Rule was met with mixed reactions from industry. While the National Association of Convenience Stores (NACS) and the National Grocers Association (NGA) had pushed for a delay of the Rule, as discussed here and here, the National Restaurant Associated (NRA) supports the Rule so its members can avoid complying with a patchwork of state and local menu labeling requirements. NRA’s concerns are already coming to fruition, as New York City (the City) Mayor Bill DeBlasio announced recently that the City will be requiring chain food retailers and restaurants with 15 or more locations nationwide to disclose calorie counts and full nutritional information.  The City is expected to begin issuing notices of menu labeling rule violations subject to fines on August 21, 2017. While NRA views FDA’s Rule as preempting the City’s analog of the same – and does not believe that the one year delay of FDA’s rule negates that preemption – the City disagrees, setting up an interesting showdown that could very well head to court.

Change in IRB Oversight of Clinical Trials

FDA announced in the June 7, 2017 edition of the Federal Register that it is making a technical amendment to its medical device regulations to reflect changes recently enacted into law by the 21st Century Cures Act (21st Century Cures).  By way of background, 21st Century Cures amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, removing the requirement for IRB  review for Investigational Device Exemption (IDE) studies and for the use of Humanitarian Device Exemption (HDE) devices. FDA’s amendment removes the term “local” from the description of IRB review in the HDE regulation; the term “local” does not appear in the Agency’s IDE regulations and thus these requirements do not need to be changed. Accordingly, medical device investigators, sponsors, and clinical sites can now choose to rely on a central IRB rather than an institution’s local IRB for these research activities. This includes IRB review for multi-site studies.

FDA Extends UDI Compliance Dates for Low-Risk Devices

On June 2, 2017, FDA sent a letter to medical device labelers in which the Agency indicated that it would be extending by two years the compliance dates for the UDI system requirements for medical devices that generally present a lower risk to patients (i.e., certain class I and unclassified devices). By way of background, the Agency published a final rule in September 2013 establishing a UDI system designed to adequately identify devices though distribution and use.  

Consistent with its June 2, 2017 letter, FDA will issue a guidance document to provide an enforcement discretion policy for labeling, Global Unique Device Identification Database (GUDID) data submission, standard date formatting, and direct mark requirements for class I and unclassified devices. This enforcement discretion policy, summarized in the table below, would not apply to class I or unclassified implantable, life-supporting or life-sustaining devices because labelers of these devices must already be in compliance with UDI requirements.

FDA Commissioner Reorganizes Agency Staff

FDA Commissioner Dr. Scott Gottlieb detailed in a May 15, 2017 memo obtained by Bloomberg News his plans to reorganize the Agency’s ORA, which carries out FDA’s inspectional activities. ORA staff will begin focusing on overseeing specific product areas (e.g., pharmaceuticals or medical devices) rather than activities in their U.S. geographic regions. While the Program Alignment plan was proposed four years ago, it is just now being implemented.

Per Gottlieb, the reorganization “will make our field programs more modern and responsive to today’s threats and challenges, while making sure that we are taking a risk-based and science-based approach to our work…We need to make sure that we are achieving the greatest degree of consumer protection with the resources that we have.”

The reorganization is not expected to result in any reductions in Agency staff, per Melinda Plaisier, Associate Commissioner for Regulatory Affairs. Currently, FDA’s 20 district offices report to five region heads.  Under the plan, however, ORA staff will report to six product-specific offices focused on:

• pharmaceutical quality;
• medical devices;
• tobacco;
• food;
• biologics; and
• research.

Agency staff overseeing imports will continue to handle all of the product types that FDA regulates, whereas the Agency’s 13 labs nationwide will focus on either: human and animal foods; or medical products, tobacco, and specialty.

Per FDA, under Program Alignment, the Agency will be better positioned to implement its authorities under the Food Safety Modernization Act (FSMA), as it will result in:

• more uniformity in both process and policy across the organization; and
• more seamless and coordinated interactions within the Agency, between the field and FDA’s centers, with other federal agencies, and with the Agency’s state regulatory and public health departments.

In welcome news for the food industry, Program Alignment is expected to make Agency inspectors more efficient and able to focus on specific commodities. Moreover, since specialized staff in FDA’s Human and Animal Food program will be trained similarly, industry should experience more uniform and consistent application of the Agency’s inspectional approach.