* This is our second post on the regulatory road ahead for life sciences companies in 2016. Our first post examined developments in food safety regulation under the Food Safety and Modernization Act.
In our last post, Life Sciences Decoded took a look at new food industry regulations that will roll out in 2016 under the FDA’s Food Safety and Modernization Act. But it’s not just the food industry that will need to prepare for a new regulatory landscape and heightened enforcement this year.
Big changes are also in store for the industries of animal health, drug, medical devices and tobacco. Among these, the FDA is expected to continue its scrutiny of animal food safety, ramp up its work in post-approval drug studies and keep a close watch on the evolution of mobile medical devices and e-cigarettes. What follows are some regulatory highlights in each area to keep close tabs on as the year unfolds.
Under the newly consolidated Center for Food Safety and Applied Nutrition, the FDA has very specific goals in continuing to ensure a safe food supply, not only for humans but animals, too. This year, expect an increased regulatory emphasis on the cross-over market (human products to animal products).
Much of the focus will continue to be on food supply chain safety. The FDA is expected to inspect feed supply manufacturers for compliance with its newly promulgated safety standards and practices in accordance with its science-based preventive control standards. These inspections will include both processing facilities and transportation methods. In addition, the FDA will continue to promote its Retail Food Program Standards and continue to monitor how companies manage food contamination and record-keeping processes.
Along with an increased focus on animal food or feed animals, it is fully expected that the agency will continue to look at the use of antibiotics in feed animals and continue to use its administrative new drug application review process to move products to the animal health market.
It is expected that while the Office of Inspector General (OIG) will focus efforts on activities subject to the Drug Supply Security Act, particularly Section 202, the FDA will focus its efforts on continued clinical trials post-approval, as well as on its pharmaceutical quality action plan. The FDA also intends to continue its efforts in patient-focused drug development. Specifically, we can expect to see:
- Increased oversight of postmarketing studies of approved drugs and increased requirements for postmarketing studies.
- Continued use of clinical outcomes assessment (COA) and the use of the compendium of COAs to not only influence the development of drugs and drug labels but to assist in drug approvals.
- A review of the rate at which members in a given drug’s supply and manufacturing chain share information and enable drug traceability to ensure that the industry is meeting traceability requirements.
- Public commentary on the draft Guidance “Safety Assessment for IND Safety Reporting,” published in December 2015.
- Continued focus on sunscreen safety after the Sunscreen Innovation Act of 2014. The FDA published three draft Guidance documents in November 2015 concerned with the accuracy of sunscreen safety and efficacy as part of 586A applications for FDA findings of Generally Recognized As Safe and Effective (or GRASE) for new sunscreen additives or combinations of additives.
The Center for Devices and Radiological Health (CDRH) will continue to closely examine medical devices, software applications and related cybersecurity issues. This will include a continued look at devices such as mobile medical applications. In fact, in an effort to get the year off to an early start, on Jan. 22, 2016, CDRH issued draft guidance on Postmarket Management of Cybersecurity in Medical Devices. The Guidance discusses the FDA’s recommendations to the device industry on how to identify and address cybersecurity vulnerabilities for marketed medical devices.
Devices that use software in their applications will be subject to a higher level of scrutiny. Where vulnerabilities are identified, these devices and their sponsors will be required to engage in remediation. Particular areas to watch include:
- A review of how hospitals and medical device manufacturers secure electronic Protected Health Information and its use over hospital networks; ensure that processes are in place to proactively plan for security of all patient data and that such processes comply with the Quality System Regulations, in addition to the new Guidance.
- Continued evolution of the new GUDID device labeling system and database in response to industry and consumer studies. This includes both industry-facing updates, as well as back-end improvements after a significant outage in the fourth quarter of 2015.
- A 2.3 percent excise tax applied to medical device companies under the Affordable Care Act was suspended for 2016 and 2017.
If you are interested in this topic, Thompson Coburn will be hosting a webinar on March 16 titled "Medical Mobile Apps: An Overview of the Regulatory Environment."
In 2014, the FDA proposed its “Deeming” rule, which, if finalized, would make many tobacco products (including cigars and e-cigarettes, or vaporizers) subject to the FDA’s jurisdiction and, therefore, its tobacco regulations. These regulations would include facilities, product, and ingredient registrations, bans on free samples, labelling requirements, and limits on the kinds of allowable marketing and advertising claims.
However, even through 2015, the Deeming Rule remains only as a proposed rule, despite the FDA’s best efforts to advance it. But even with this stalemate, the FDA’s Tobacco Center has implemented new regulations affecting tobacco products and their entry into the market as evidenced by the implementation of premarket tobacco applications for new tobacco products. This is a new pathway to market for tobacco products that creates a new regulatory hurdle for the tobacco industry requiring them institute and implement a regulatory strategy for their new products to ensure that they can obtain a favorable review of premarket applications. In addition, the FDA will continue its efforts through 2016 in filing complaints against retailers using No-Tobacco-Sale Order actions.
Time to act
FDA-regulated companies must be doing more than just thinking about the impact of these regulations. Instead, they should be drafting a plan for compliance and thinking through the implementation of these plans. The time is fast-approaching when the FDA will commence inspections and subsequent enforcement actions.
If you or others at your company would like to discuss the best way to manage these changes and best practices in developing compliance programs, please contact Thompson Coburn LLP partner Diane Romza-Kutz .Our life sciences practice has decades of experience working with FDA-regulated industries and interfacing with the agency.
Diane Romza-Kutz is a partner in Thompson Coburn's Health Law Practice Group.