- Speech by
Lauren Silvis, JD
Chief of Staff - Office of the Commissioner
Remarks as prepared for delivery)
Good morning. I’m honored to be speaking here today.
The FDA and the Consumer Healthcare Products Association (CHPA) have had a long and productive dialogue around health and safety issues related to the many consumer products regulated by the Agency.
We share the goal of ensuring safe and timely consumer access to effective nonprescription drug products. These products can empower consumers to self-treat common conditions; including chronic conditions that may be under-diagnosed or undertreated because of cost or access barriers.
The FDA supports initiatives that will open doors to innovation in the market place for nonprescription drugs, both for OTC monograph products and for products approved under a new drug application (NDA).
On the monograph side, I want to make clear today that OTC monograph reform remains a top priority for the Agency.
On the NDA side, we are pushing forward with the Nonprescription Safe Use Regulatory Expansion (also known as NSURE) to help facilitate prescription to nonprescription switches.
With these initiatives, we continue to encourage innovation to increase consumer access to a broader selection of nonprescription drug products. Nonprescription products save consumers and employers billions of dollars in annual health care costs, including time lost seeking a doctor’s appointment for a prescription for minor ailments that can be treated without prescription.
As Chief of Staff and a busy parent of two young children, I know first-hand that nonprescription products provide important treatment options for families and caregivers who don’t always have the option of getting to a doctor’s visit for minor ailments. Or when there’s a medical issue in the middle of the night that doesn’t rise to the level of an emergency room visit.
In some cases, the information needed to ensure consumers can self-select or use a nonprescription NDA product doesn’t fit or can’t be accommodated within the traditional Drug Facts Label (DFL); for instance, when there may be a serious risk of drug-drug interactions.
FDA has received many questions and suggestions from sponsors about innovations that could increase the number of NDA drug products that can be marketed as nonprescription when the DFL is not sufficient to ensure that consumers can self-select, or use a drug product, without the supervision of a health care practitioner.
We agree that this is an important opportunity to improve public health, and in July 2018 FDA issued a draft guidance titled “Innovative Approaches for Nonprescription Drug Products.” The draft guidance encourages industry to continue to innovate as they develop and seek approval of certain nonprescription drug products.
The draft guidance describes two innovative approaches to consider when the DFL alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting: 1) the development of labeling in addition to the DFL and 2) the development of one or more additional conditions that consumers must fulfill to ensure that the drug product is safe and effective for nonprescription use, when the DFL and labeling are not sufficient. We’re open to hearing from sponsors who want to pursue this approach in the context of an individual application. We are actively working on a proposed rule that will provide more information on this topic.
Innovative ways to ensure that consumers can self-select and use a drug product safely in the nonprescription setting could include a variety of digital health technologies, such as use of self-selection tests in mobile applications, in-store digital kiosks, or other tools.
We encourage sponsors to innovate and harness new digital health technologies that can facilitate a more competitive market for nonprescription NDA products, and support consumers in appropriately and safely self-selecting nonprescription products in cases where the traditional drug facts label (DFL) alone is not sufficient to ensure that the drug product can be used safely in a nonprescription setting.
These approaches can help ensure appropriate benefit-risk balance for nonprescription medications for certain chronic conditions that affect a large percentage of Americans. Research suggests that many patients with these conditions remain undiagnosed or undertreated. Broader treatment of these conditions could help improve public health.
Responsible innovation and development into these solutions can help novel nonprescription products reach consumers.
The OTC monograph system serves a different but extremely important purpose. It allows for marketing of a wide range of nonprescription drugs with different regulatory oversight than NDA drugs.
Each monograph can provide for the marketing of hundreds, or even thousands or products. Products that meet OTC monograph specifications as generally recognized as safe and effective are not required to be reviewed by the FDA before marketing.
The monograph system should be modernized to allow for more innovation. The OTC reform legislation, which has broad support does just that.
FDA has long engaged in this effort, and we will continue to do so, working with all stakeholders and Congress to make clear that OTC monograph reform is a critical public health priority. It’s in the best interest of patients to modernize the monograph system. That means that FDA will continue to engage on this issue, until we have a system for OTC drugs that provides Americans what they need to better manage their own health care. We know it’s up to Congress to legislate on this issue, but you’ll continue to hear from FDA that OTC modernization will help consumers take charge of their own healthcare, promote safety and innovation, and help Americans lead healthier lives.
Modernizing Regulation of Sunscreen Ingredients
We also know there is significant interest in our proposed rule issued in February for modernizing the regulation of sunscreens.
As we work to finalize this rule, we will consider all comments to the proposed rule very carefully.
Our proposed rule is part of our ongoing effort to ensure sunscreens are safe and effective for regular, life-long consumer use.
Our proposals are focused on ensuring that sunscreens provide consumers with the protection that they need and expect against skin cancer, through updated broad spectrum and sun protection factor (SPF) criteria. It also addresses
• the status of sunscreen active ingredients;
• dosage forms including sprays;
• sunscreen plus insect repellant combinations;
• sunscreen product labeling; and
• final formulation testing and record keeping.
Importantly, our request for additional data on 12 active ingredients found in currently marketed sunscreens does not mean FDA has concluded that these ingredients are unsafe for this use.
It means that additional data are still needed so that the FDA can fully assess these ingredients in light of evolving science.
For instance, given that we now have clinical evidence that some of these ingredients can be absorbed, we need more data to determine the extent of absorption, if any. And for those with more than minimal absorption, we need to consider potential systemic effects, including carcinogenicity, and potential effects on the human endocrine and reproductive systems.
It’s critical that industry continue to collect the data and do the necessary studies. This is especially important with evolving sunscreen use, as many consumers consider them part of their daily health routines to reduce the risk of skin cancer or early skin aging caused by the sun.
We want consumers to continue to use sunscreen to protect themselves from the sun. We’ll continue to communicate this message. FDA recommends that consumers use broad spectrum sunscreens with SPF 15 or higher in conjunction with other sun protection measures. That hasn’t changed.
Our goal is to continue to promote innovation and improve the quality, safety, and efficacy of sunscreens, and we’ll continue to work with stakeholders to make sure consumers have access to safe and effective sunscreens.
Modernizing Dietary Supplement Regulation
Dietary supplements represent another area where there is potential for significant market innovation, and it’s important that our regulatory framework can adapt to and even encourage responsible dietary supplement innovation.
The dietary supplement marketplace has grown exponentially in both size and scope since the Dietary Supplement Health and Education Act of 1994 (DSHEA) was enacted.
FDA’s creation of the Office of Dietary Supplement Programs elevated the program from its previous status as a division and reflected the Agency’s recognition we needed to elevate dietary supplement regulation to effectively fulfill our public health mission.
This year we plan to make that continued evolution a priority.
Taking a dietary supplement – such as vitamins, minerals, or herbs – has become a daily routine for many Americans. Today, the $40 billion a year supplement industry reaches 170 million Americans, with 50,000 to 80,000 different products that claim to help maintain or improve health.
But for consumers to make informed choices with these products, they need to have access to safe, well-manufactured, and appropriately labeled products.
While many dietary supplements meet the FDA’s standards, there are some companies who are knowingly distributing and selling dangerous or otherwise illegal products that put consumers’ health and lives at risk.
As the Agency entrusted with the oversight of dietary supplements, we will not stand by and allow these companies to compromise the health of consumers or abuse their trust.
In February, we announced new efforts to strengthen the regulation of dietary supplements by modernizing our regulatory framework; and recognizing the role that responsible supplement innovation can play in supporting consumer health.
We also launched a new tool to quickly alert the public when we become aware of ingredients that appear to be unlawfully marketed in dietary supplements: the Dietary Supplement Ingredient Advisory List, now available on the FDA website.
The introduction of new ingredients into the marketplace often raises complex questions involving science, policy, and the law. In the time it takes the FDA to make a final determination about the legal status of such ingredients, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful.
Our list is intended to get information rapidly to both consumers and industry, while also providing an opportunity for stakeholders to share information with us that they think might be relevant to our determination.
As in many cases of the FDA’s regulatory actions, we’re attempting to strike the right balance between preserving consumer access to lawful and beneficial dietary supplements, while also protecting Americans from the potential dangers of products that don’t meet the Agency’s standards for dietary supplements.
We also hosted a public meeting last week on Responsible Innovation in Dietary Supplements with broad participation.
It’s important for us to hear ideas for how we might facilitate responsible innovation in dietary supplements while ensuring or even strengthening FDA’s ability to protect the public from unsafe and unlawful products. The comment period for that meeting is open until mid-July.
Supporting A Science-based Framework for Cannabidiol (CBD) in Food and Dietary Supplements
The 2018 Farm Bill’s removal of hemp from the Controlled Substances Act (CSA) means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under Federal law. This has certainly amplified the interest in marketing cannabidiol (CBD) products, or CBD infused products.
This interest spans the gamut of product categories that the Agency regulates, including human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics.
However, FDA’s authorities were specifically preserved by the Farm Bill, and cannabis and cannabis-derived products are subject to the same authorities and requirements as FDA-regulated products containing any other substance.
We recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to CBD products, and what pathways might be available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products.
FDA realizes the importance of this topic and has formed a cross-Agency working group of senior Agency staff to address this issue. FDA’s CBD working group is continuing to explore potential pathways for various types of CBD products to be lawfully marketed, consistent with the public health.
Establishing the safety of consumer products requires addressing current scientific gaps in our understanding of CBD. Closing these gaps - for instance, in our understanding of the potential effects of cumulative exposures across foods, supplements, and cosmetics – will help inform the agency’s path forward.
Products should be marketed after addressing fundamental practical and scientific uncertainties that allow them to be developed and marketed responsibly, and that allow consumers to make truly informed choices.
Strong scientific data supports both effective regulation and responsible innovation. We’re looking to the scientific community and industry to help us generate or obtain high quality data.
In order to inform the regulatory path forward, FDA is holding a public hearing on May 31 to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds. This hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.
As part of that hearing, FDA has opened a docket for the public to submit comments. Specific topics of interest include: Health and Safety Risks, Manufacturing and Product Quality, and Marketing/Labeling/Sales.
I hope that all stakeholders will continue to engage with the Agency, and to help us consider what regulatory changes might be needed and what the impact of such marketing would be on the public health based on reliable scientific research. We encourage you to provide information and data to the open docket.
Our goal in CBD regulation, as in all our regulation, is to protect the public from unsafe or ineffective products, including products that are making unproven disease claims that may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
Ultimately, the steps the FDA is taking will allow us to continue to clarify our regulatory authority over these products, seek input from a broad range of stakeholders and examine a variety of approaches and considerations in their marketing and regulation, while continuing to make sound, science-based decisions to protect the public’s health and safety.
Agency Initiatives to Advance Innovation
We're at an extraordinary moment for public health and medical innovation, driven by rapid, parallel advances in computing technologies and advances in our understanding of basic human biology unleashed by the deciphering of the human genome.
To fully harness these advances for the benefit of public health, the Agency is modernizing our policies, procedures, and IT infrastructure to prepare for more complex product submissions, including submissions that incorporate more real-world data.
I’d like to conclude today by talking about two ways the Agency is modernizing for innovation by strengthening our ability to analyze and incorporate novel types of data efficiently and at scale.
First, we’re reorganizing the Office of New Drugs. The OND reorg will help create time and space for OND staff to grow their scientific expertise and thought leadership.
To enable our scientists to have more time to focus on core scientific and regulatory endeavors, CDER’s Office of New Drugs is standardizing reviewers’ workflow, roles and responsibilities.
For example, we’re strengthening administrative, regulatory project management, policy, and drug development tools functions to provide enhanced support to OND’s clinical review staff. Also, certain OND review offices and divisions are being clustered to better reflect current and emerging understandings of disease and opportunities to leverage new approaches like digital health tools.
The result is that FDA’s subject matter experts will have more time, better analytic tools, and more knowledge management support to advance the clinical and regulatory principles we rely on to evaluate the safety and efficacy of innovative products, including innovative approaches for OTC products.
We’re also engaging more with stakeholders in the development of new approaches for collecting real world evidence through platforms like smartphone apps.
Last year we launched FDA’s MyStudies app, which is an open source, digital platform for gathering real world evidence for clinical trials and research studies, including, potentially, for OTC products.
In a world where close to 80% of Americans have a smartphone – more than own a laptop or desktop – apps can help stakeholders leverage mobile technologies to better capture real world evidence in clinical trials and research studies.
The MyStudies app is available in standard frameworks and includes a web-based configuration portal that can enable support of multiple types of medical product effectiveness and safety studies. The app requires minimal software development and operates in a secure storage environment that can be partitioned for multisite, decentralized, or distributed trials.
In a recent FDA webinar for the MyStudies app, researchers and individuals from 60 countries on 6 continents engaged with FDA’s MyStudies development team to explore how to develop additional use cases and improve app functionality in the open source space. (The source code can also be customized for proprietary software development.)
The MyStudies app is currently being tested in a Patient Centered Outcomes Research Institute (PCORI) funded trial for Limited Juvenile Idiopathic Arthritis; and a Crohn’s and Colitis Foundation registry supporting PCORI trials testing comparative effectiveness studies of biologics and small molecule therapies for inflammatory bowel disease.
As FDA modernizes our organization, policies, and procedures, we’re becoming more agile and efficient in assessing the products we regulate, while strengthening our ability to detect significant safety and efficacy signals in both the pre- and post-market.
And by crowdsourcing platforms like the MyStudies app, we’re engaging the research community in pressure testing the standards and concepts all stakeholders need to integrate real world data into high quality research that is suitable for regulatory submission.
We’re not waiting for the future to come us. We’re actively modernizing for the kinds of novel innovations we expect to see across our entire regulatory portfolio, from drugs to foods and dietary supplements.
And we look forward to working with all stakeholders to support the development of responsible product innovations to benefit patients and consumers, now and in the future.