A personal note from Brad Thompson:
As I look at the following list of issues where I’ve been privileged to play a role, I think mostly of all of the wonderful people who have helped me and guided me and taught me. I’ve had the extraordinary blessing of the chance to work with clients with tremendous vision who see opportunities for improvement, always keeping a focus on the patients we are here to serve. I think of mentors who have allowed me to join their team and have patiently shown me the way, and I think of brilliant and hard-working young people who have made me look good. I’d like to thank all of them. I’ve accomplished nothing by myself.
1994 through 1998 – Good Guidance Practices
Initially for the Indiana Medical Device Manufacturers Council but eventually on behalf of a broad coalition of major trade associations in the food, drug, medical device, and veterinary medicine industries.
For this group, Brad sought reform in the way FDA gives guidance to the regulated industries. Prior to 1994, FDA had a very helter-skelter system through which companies often couldn’t even find relevant guidance documents, and FDA had a penchant for announcing new policy from the podium. Many of the guidance documents did not receive public input, and sometimes were poorly conceived.
Brad filed a citizen’s petition at FDA requesting that they adopt “good guidance practices.” He testified before Congress and at an FDA hearing, explaining the challenges faced by industry and offering proposed improvements. FDA adopted a regulation implementing good guidance practices, and in 1997 as a part of FDAMA, Congress required FDA to observe good guidance practices.
After FDA adopted these policies, Brad sought the same reforms at CMS. Congress imposed good guidance practices on that agency as well.
In 2005, OMB proposed and in 2007 adopted good guidance practices for all federal agencies.
1996 through 1997 – Disseminating Health Economic Information
A group of companies and trade associations in the pharmaceutical industry.
Brad was engaged to develop a policy consensus among relevant stakeholders on a mechanism to better share health economic information with managed care organizations developed by pharmaceutical companies. The work resulted in the passage of section 114 of FDAMA on that topic.
1997 to 2000 – Openness in Medicare Coverage Decision-making
Initially on behalf of the Indiana Medical Device Manufacturers Council but later for a broader coalition.
Several companies were deeply disturbed by the fact that the predecessor to CMS before 1998 was seeking advice on coverage decisions behind closed doors from a so-called Technology Advisory Committee. The committee was comprised in significant part of private insurance company representatives. The agency was using that input as a basis for denying Medicare coverage for new medical technology.
Brad did a legal analysis showing that CMS was violating the Federal Advisory Committee Act. Brad shared that analysis with Congressman Bill Thomas, the then chairman of the Ways and Means Committee. Mr. Thomas gave the letter to the GAO and asked them to investigate. The GAO concurred with Brad’s analysis, and Chairman Thomas demanded that CMS disband the group.
Brad then pressed CMS through a citizens petition asking that the coverage process be more transparent and objective. Eventually CMS published a revised process that sought to bring greater transparency and predictability to their coverage decision-making.
1999 to 2002 – Medicare Coverage Appeals
On behalf of medical device companies and trade associations.
Prior to 2000, if any party disagreed with a coverage decision in the Medicare program, their only option was to appeal an individual claim filed by and through an individual beneficiary. Further complicating the problem, when an appellant achieved a favorable decision on appeal, that appellate decision carried no weight in other proceedings. So if a provider or a manufacturer opposed a coverage decision generally, they were forced to fight every single individual Medicare claim essentially forever.
Brad and others asked that Congress create an appeal procedure that would allow an appropriate stakeholder to appeal a coverage policy developed either by a Medicare contractor or by CMS. Congress agreed, and enacted policy appeals in the Medicare, Medicaid and SCHIP Benefit Improvement and Protection Act of 2000 (BIPA). Brad then worked with CMS to develop appropriate implementing regulations.
1997 to 2001 – Regulation of Simple Diagnostics Under CLIA
On behalf the Indiana Medical Device Manufacturers Council, and a variety of diagnostic device manufacturers and other medical device and diagnostic trade groups.
Brad worked with FDA to achieve a more sensible system of regulating in vitro diagnostics under CLIA, especially those that are simple enough to use in a doctor’s office or at home. In vitro diagnostics are subject to two different statutes: the Federal Food, Drug and Cosmetic Act as well as the Clinical Laboratory Improvement Amendments of 1988. Initially responsibility for regulating these products was divided among the FDA, CDC and CMS.
Brad drafted a petition seeking improvements to the process of making CLIA categorization decisions. At the urging of the coalition, the process for evaluating new technologies was shifted from the CDC to FDA on January 31, 2000. In 1997, Brad also worked with Congress in FDAMA to clarify that an FDA determination that a product is simple enough to be used in the home means it’s also simple enough to be waived under CLIA. He further worked with FDA to develop a more efficient process for making CLIA waiver determinations.
1997 through 2008 – Medicare Issues Including IVD Payment
Served as Chief Payment Counsel to AdvaMed.
During his tenure, Brad worked on all manner of Medicare payment issues including developing a proposed new system for payment of diagnostics, and on encouraging FDA/CMS collaboration.
On behalf of AdvaMed, in 1999 Brad successfully challenged the use by CMS contractors of the so-called “inherent reasonableness” authority. Brad successfully argued that the contractors were making what was, in effect, a national payment decision but were skirting the appropriate administrative processes.
In 2007, Brad helped AdvaMed successfully challenge a CMS interpretation of its Medicare Clinical Trials Policy to exclude otherwise covered items and services from Medicare coverage if they were used in research.
In addition, Brad represented AdvaMed on FDA administrative law issues, FDA regulation of diagnostics, and other topics.
2002 through 2006 – Medicare Payment for Blood Glucose Testing Supplies
Coalition of companies in the diabetes product category.
The coalition’s goal was to work with CMS to arrive at a more sensible payment system. The coalition met with the agency to discuss options, and when Congress enacted its competitive bidding system, the coalition worked with CMS to figure out how best to implement that new system.
2002 to 2005 – FDA Regulation of Lab Developed Tests and IVDs
A coalition of IVD companies.
Clinical labs in the late 1990s began to enter the market for high-volume diagnostic tests. An informal and largely unwritten policy at FDA allowed clinical labs to develop their own tests for their own purposes, but the practice started to grow beyond what FDA had envisioned. At the time, management at FDA was uncertain whether the agency had the legal authority to regulate LDTs.
In 2003, Brad wrote a 36 page legal analysis which he presented to FDA, explaining the legal basis for FDA regulation of LDTs. Brad worked with management at FDA to analyze the issue, ultimately convincing the agency that it did indeed have authority. FDA has now proposed a specific regulatory framework for LDTs.
At the same time, the coalition searched for a better approach to regulating IVDs overall. FDA was requiring very substantial clinical trials to demonstrate the clinical utility of IVDs, and in practice this requirement delayed introduction of new products sometimes by years. Brad met with FDA to discuss various options, and submitted a proposed guidance document in 2003 to create a new category called “In Vitro Analytical Tests or (“IVATs”). In this new approach, manufacturers would validate the analytical performance of a test, but the user would validate the clinical performance. Industry and FDA continue to this day looking for models that are jointly satisfactory, balancing the need for speedy innovation with safety and effectiveness.
2003 through present – FDA Regulation of Combination Products
On behalf of a group called the Combination Products Coalition (CPC), comprised of companies in the drug, medical device, and biologics industries that make combination products.
As General Counsel of the CPC, Brad works with FDA’s Office of Combination Products to improve the system for regulating such products. The group regularly develops policy recommendations and meets with the agency. Combination products are combinations of drugs, devices and/or biologics. Many physicians and scientists consider such convergence of technology to be the wave of the future, and our best hope for improved safety and effectiveness.
For about 10 years, the coalition has been pressing for clarifications to the agency’s approach to GMPs for combination products. Working with the agency starting with its concept paper in 2004, through proposed and final rules and now a proposed guidance, the coalition is finding the clarity it’s been looking for.
Among other issues, the coalition is seeking the improvement of the level of coordination among the centers as they review combination product submissions. The coalition is also working with FDA to improve the process for reviewing companion diagnostics in particular.
With regard to an issue near and dear to Brad’s heart, the coalition has been advocating more recently for a fresh look at how FDA develops guidance documents. Now 20 years after the original good guidance practices, it’s time for GGP 2.0.
2008 to 2015 – Interoperability and Connected Health
Continua Health Alliance, a founding member of the Personal Connected Health Alliance (PCHA). The PCHA is an international non-profit organization established by Continua, mHealth Summit, and HIMSS to represent the consumer voice in personal connected health.
Brad has served as regulatory counsel to the Continua Health Alliance. Continua is dedicated to the development of its Design Guidelines that include global industry standards to ensure end-to-end, plug-and-play interoperability of personal connected health devices for the seamless and secure collection, transmission, and storage of personal health data.
With Continua, Brad helped organize a summit meeting with FDA as well as ongoing discussions regarding how to achieve interoperability.
2010 to 2015 – FDA Regulation of Mobile Health
Prior to 2013, FDA offered very little guidance on when and how companies involved in mobile health are regulated. As General Counsel to the MRC, Brad worked with FDA to develop appropriate rules limiting when technology such as cell phones and other communication and IT devices can get swept within the regulated category of medical devices.
In March 2013, Brad testified before Congress on the connection between the mobile app issues and the medical device tax.
As a part of this work, in the summer of 2013, Brad served as cochair of the Regulations Subgroup of the section 618 FDASIA working group. That group of stakeholders met approximately 30 times over the course of the year to make recommendations to FDA, ONC, and FCC on an overarching strategy for regulating health information technology.
In addition to the September 2013 FDA guidance on mobile medical apps, FDA published two additional guidances requested by the MRC. In January 2015, FDA published a guidance document that defines the difference between a regulated medical device and a wellness product. That same month, FDA also issued a guidance explaining the triggers for making a product an accessory to a medical device. The coalition identified those two topics, together with clarity around mobile medical apps, as key areas where regulatory guidance was needed to help unleash the potential of mobile health.
2012 to present – FDA Regulation of Clinical Decision Support Software
Since 2011, FDA has been wrestling with how to approach software that stands alone and aids a clinician or a patient in clinical decision-making. Such software spans a wide range from very simple programs that aggregate relevant data, to sophisticated programs that help a radiation oncologist decide the right dosing strategy. Everyone seems to agree that at the low-end such software should not be regulated and at the high-end it should. The question is where to draw the line.
The coalition spent a couple of years developing a model for differentiating regulated and unregulated CDS, partly on the basis of whether the software is designed to be transparent. Transparency means that the user can see through the software to view the underlying data on which recommendations are based, and understand the clinical logic the software is applying. Brad then advocated the use of transparency as a principle for distinguishing regulated from unregulated, in discussions with both FDA and Congress.
Brad’s advocacy directly led to two policy developments: Section 3060 of the 21st Century Cures Act, which codified the transparency concept, enacted in December 2016; and FDA’s proposed guidance on clinical decision support software, in December 2017. In 2018, Brad, on behalf of the CDS Coalition, commented on the proposed guidance for CDS, recommending that FDA (1) layer in the International Medical Device Regulators Forum (IMDRF) risk framework and exempt low risk CDS, (2) remove language inconsistent with the statute that would prevent software based on machine learning from ever being exempt, and (3) re-propose the guidance. FDA adopted all three recommendations in its September 2019 re-proposal of the CDS guidance. Brad also drafted, on behalf of the coalition, industry guidelines for achieving transparency in clinical decision support software.
2019 to present – FDA Regulation of Artificial Intelligence in Health Care
Founded by Brad, the AI Startups in Health Coalition (AISHC) represents the combined voice of artificial intelligence (AI) startups focused on health care. Arising from the 2019 Startup Roadshow held at major engineering schools across the United States, AISHC’s mission is to ensure that startup companies have a voice in FDA’s future plans to regulate AI. To ensure that cash-strapped startups can participate, there is no cost to join the coalition.
In 2019, FDA made two major announcements of policy initiatives intended to fundamentally change its approach to regulating AI used in patient diagnosis or treatment: (1) the so-called precertification program and (2) the new approach to regulating AI, including Good Machine Learning Practices. However, the proposed FDA approach on both is unsuitable in many ways, particularly for startups. The proposals appear to disadvantage startups that don’t have a track record of bringing new technology to market.
There will likely be much discussion of the best approach in the coming years, and AISHC is working with startups to find consensus and advocate for their interests.