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Statement from FDA Commissioner Scott Gottlieb, MD, on advancing new digital health policies to encourage …
Today we’re announcing three new, significant policy documents to advance the FDA’s approach to the development and proper oversight of innovative digital health tools. We know that consumers and health care providers are increasingly embracing digital health technologies to inform everyday decisions. From fitness trackers to mobile applications tracking insulin administration, these digital tools can provide consumers with a wealth of valuable health information. Further, clinical evidence demonstrates that consumers who are better informed about health make better and more efficient decisions, take steps to improve their lifestyles and their health choices, and often experience better outcomes.
Given these meaningful benefits from empowering consumers, we believe the FDA must, whenever possible, encourage the development of tools that can help people be more informed about their health. And we recognize that our regulations play a crucial role in the efficient development of such technologies. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation. Moreover, we must always lean in the direction of enhancing access to more information – not restricting information flow – given the ability of reliable information to positively impact daily life.
Over the last five years, the FDA has made great strides in adapting our policies to better align our regulatory approach to the iterative nature of digital health products. We’re finding that in some parts of our regulatory portfolio, our traditional approach to overseeing certain health care products does not easily fit the types of innovations that are being developed. In these cases, we must adapt and evolve our policies to make sure we continue to provide a gold standard for oversight, while enabling advancement of beneficial innovations and greater consumer access to technologies that can improve their health.
To this aim, this past summer, we issued the Digital Health Innovation Action Plan, which outlines our efforts to reimagine the FDA’s approach to ensuring all Americans have timely access to high-quality, safe and effective digital health products. As part of this plan, we committed to several key goals, including increasing the number and expertise of digital health staff at the FDA, launching the digital health software precertification pilot program (“Pre-Cert”) and issuing guidance to modernize our policies.
As we come to the end of 2017, I’m proud of the significant progress the FDA’s digital health team has made on the Action Plan. We launched the Pre-Cert pilot and selected nine diverse companies to participate. We also have invested in hiring additional talent for our digital health team, including announcing the Entrepreneurs in Residence program. Yet, we recognize there’s more work to do.
Today, we’re announcing three new guidances – two draft and one final – that address, in part, important provisions of the 21st Century Cures Act (“Cures Act”), that offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement. We’ve taken the instructions Congress gave us under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the goals we were entrusted with by Congress.
The first draft guidance, “Clinical and Patient Decision Support Software,” outlines our approach to clinical decision support software (CDS). CDS has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition. For example, such software can include programs that compare patient-specific signs, symptoms or results with available clinical guidelines to recommend diagnostic tests, investigations or therapy. This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making. We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.
This draft guidance is intended to make clear what types of CDS would no longer be defined as a medical device, and thus would not be regulated by the agency. For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation. This type of CDS can include software that suggests a provider order liver function tests before starting statin medication, consistent with clinical guidelines and approved drug labeling.
However, the FDA will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act. For example, we would continue to oversee software that analyzes data from a patient’s spinal fluid test to diagnose tuberculosis meningitis or viral meningitis. These are areas in which the information provided in the clinical decision software, if not accurate, has the potential for significant patient harm, and the FDA plays an important role in ensuring the safety and effectiveness of these products.
Similarly, the CDS draft guidance also proposes to not enforce regulatory requirements for lower-risk decision support software that’s intended to be used by patients or caregivers — known as patient decision support software (PDS) — when such software allows a patient or a caregiver to independently review the basis of the treatment recommendation. Although PDS was not part of the Cures Act, the FDA believes that PDS should follow a similar regulatory structure as CDS. An example of lower-risk PDS products could include software that reminds a patient how or when to take a prescribed drug, consistent with the drug’s labeling. PDS software that does not clearly allow independent review of the recommendation by the patient or a caregiver would continue to be subject to the FDA’s active oversight. This might include a warfarin monitoring device that makes recommendations for dosing based on the outcome of a home blood test.
We believe our proposals for regulating CDS and PDS not only fulfill the provisions of the Cures Act, but also strike the right balance between ensuring patient safety and promoting innovation.
The second draft guidance being issued today, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,” addresses other digital health provisions included in the Cures Act. Specifically, this second guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices. We’re making clear that certain digital health technologies – such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle – generally fall outside the scope of the FDA’s regulation. Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system.
Through this draft guidance, we’re proposing changes to previously published agency guidance documents, including: General Wellness and Mobile Medical Applications, among others, to be consistent with the Cures Act and reflective of the agency’s new, more modern approach to digital health products. The proposed changes include updating the categories of products for which, prior to the Cures Act, the FDA already intended to exercise enforcement discretion owing to their very low risk and potential benefits to patients from greater innovation. Now, to create an even clearer distinction, consistent with the Cures Act, we’re saying that many of these products no longer qualify as medical devices that would be subject to the FDA’s oversight.
In addition to taking steps to clarify the FDA’s position on digital health, we’re also working with our global counterparts to harmonize and streamline the regulation of digital health products internationally.
Innovations in digital health remind us that we live in an interconnected world – one that reaches across borders and joins us in new and unique ways. That’s why in recent years, we’ve worked closely with regulatory authorities across the globe through the International Medical Device Regulators Forum (IMDRF) to evaluate requirements in individual countries, and harmonize our regulatory approaches to digital health medical devices, where possible. Many of our global counterparts are represented, including Australia, Brazil, Canada, China, the European Union, Japan, Russia and Singapore.
As part of our package of policies being announced today, the FDA also is issuing a final guidance, “Software as a Medical Device: Clinical Evaluation,” in fulfillment of these international harmonization efforts. This guidance was initially issued in draft in October 2016 and informed by global and domestic comments. Today’s final guidance expands on that draft. It establishes common principles for regulators to use in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD). This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. The agency’s adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight, and is another important piece in our overarching policy framework for digital health.
In sum, these three important guidance documents being issued today will continue to expand our efforts to encourage innovation in the ever-changing field of digital health. Our aim is to provide more clarity on and innovative changes to our risk-based approach to digital health products so that innovators know where they stand relative to the FDA’s regulatory framework. Our interpretation of the Cures Act is creating a bright line to define those areas where we do not require premarket review. And we’re providing more detail on those technologies and applications that would no longer be classified as a medical device subject to FDA regulation. This will allow us to focus our efforts on the highest-risk products. Finally, we’re issuing new details on the common principles we and our international partners will use for evaluating the safety and effectiveness of SaMD. Through this comprehensive approach, we can deliver on our commitment of promoting beneficial innovation in this space while providing proper oversight where it’s merited.
We’ll be taking other steps to implement our Digital Health Innovation Action Plan. We’re hosting a Pre-Cert Pilot Program workshop on January 30-31, 2018 to update FDA staff, participants and stakeholders on the lessons learned from the pilot. Later in the year, we’ll share the pilot’s proof of concept and outline next steps for establishing a Pre-Certification Program. We look forward to working with patients, providers, technology developers and other customers in helping Americans access safe and innovative digital health products.
Statement from FDA Commissioner Scott Gottlieb, MD on FDA advisory about deadly risks associated with kratom
The FDA is concerned about harmful unapproved products that have been crossing our borders in increasing numbers. The agency has a public health obligation to act when we see people being harmed by unapproved products passed off as treatments and cures for serious conditions.
Over the past several years, a botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. Today, the agency issued a public health advisory related to the FDA’s mounting concerns regarding risks associated with the use of kratom.
Kratom is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. It has gained popularity in the U.S., with some marketers touting it as a “safe” treatment with broad healing properties. Proponents argue that it’s a safe substance largely because it’s a plant-based product. The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider. We also know that this substance is being actively marketed and distributed for these purposes. Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death. Thus, it’s not surprising that often kratom is taken recreationally by users for its euphoric effects. At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning.
It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs.
There’s clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.
Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.
I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. The FDA has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic claims and is committed to facilitating development of botanical products than can help improve people’s health. We have issued guidance on the proper development of botanical drug products. The agency also has a team of medical reviewers in the FDA’s Center for Drug Evaluation and Research that’s dedicated to the proper development of drug applications for botanicals. To date, no marketer has sought to properly develop a drug that includes kratom.
We believe using the FDA’s proven drug review process would provide for a much-needed discussion among all stakeholders. Until then, I want to be clear on one fact: there are currently no FDA-approved therapeutic uses of kratom. Moreover, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with. Moreover, Congress has also established a specific set of review protocols for scheduling decisions concerning substances like kratom. This is especially relevant given the public’s perception that it can be a safe alternative to prescription opioids.
The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements. To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S. At international mail facilities, the FDA has detained hundreds of shipments of kratom. We’ve used our authority to conduct seizures and to oversee the voluntary destruction of kratom products. We’re also working with our federal partners to address the risks posed by these imports. In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom. Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee and Wisconsin and several others have pending legislation to ban it.
We’ve learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene. From the outset, the FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold.
As a physician and FDA Commissioner, I stand committed to doing my part to prevent illegal substances that pose a threat to public health from taking their grip on Americans. While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighed appropriately against the potential for abuse. They must be put through a proper evaluative process that involves the DEA and the FDA. To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom’s risk and benefit profile, so that well studied and potentially beneficial products can be considered. In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
(Reuters) – U.S. Food and Drug Administration Commissioner Scott Gottlieb, considered a potential successor to recently departed Health and Human Services Secretary Tom Price, said on Tuesday he believed he could best serve the Trump administration in his current role.
“I feel like I want to continue to follow through on the policies we’ve put out and it’s where I think I can be most effective,” Gottlieb told Reuters in an interview in New York.
He declined to say whether he had been approached about the job by the White House. “I‘m not going to get into private discussions I might have had around that,” he said.
Gottlieb is one of several potential candidates for the top job at HHS, a post vacated by Price last month following an uproar over his use of private jets for government business.
Other names mentioned by health policy experts include Seema Verma, administrator of the Centers for Medicare Medicaid Services (CMS) and Louisiana Governor Bobby Jindal.
Gottlieb has won mostly positive reviews since taking over as FDA commissioner in May. He has introduced policies tackling some of the country’s biggest health challenges, including opioid and tobacco addiction and rising prescription drug prices.
The top post at the FDA has always been difficult to fill, Gottlieb noted, and there have been long stretches where the agency has operated under an acting commissioner.
Gottlieb once served as senior adviser to FDA commissioner Mark McClellan, who left the agency in 2004 after just two years to run CMS, a move that Gottlieb said was detrimental to the agency.
“It’s always challenging to move an FDA commissioner,” he said. “Continuity of leadership there is important.”
In a wide-ranging interview, Gottlieb said the situation on the ground in Puerto Rico, where 10 percent of drugs prescribed in the United States are made, was “very bad” and that shortages of some drugs could emerge within as little as two to three weeks.
He also said the agency is going to more clearly define regulations around cell therapies. The law currently states that if a cell is extracted from a patient’s body and more than minimally manipulated it is a drug subject to FDA regulation.
“Historically the FDA hasn’t vigorously enforced around that line because it didn’t have the implementing guidelines to do that,” he said.
At the same time, the agency plans novel measures to make it easier for small academic centers to apply for FDA product approval by pooling data generated from similar work.
“If academicians working at different academic sites are doing a similar procedure with stem cells, if they are all following the same protocol, then they’re going to be able to pool their data to submit it for regulatory approval,” he said.
Reporting by Toni Clarke; Additional reporting by Michael Erman and Bill Berkrot; Editing by Michele Gershberg and Bill Rigby