Photo of Wade Ackerman

Wade Ackerman

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. He co-leads Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable global resources to advise life sciences and health technology clients harnessing the power of information technology and data to create new and cutting-edge innovations to improve health and achieve better outcomes for patients.

Until June 2016, Wade served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) and, prior to that, Chairman Tom Harkin (D-IA). While at the HELP Committee, Wade was involved in all major FDA legislative initiatives, oversight hearings, and other Senate HELP Committee activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act. From January 2015 through June 2016, he helped negotiate many of the FDA-related provisions in the 21st Century Cures Act, which included reforms to FDA’s review and approval of new drugs, devices, combination products, and digital health software. He also worked closely with the FDA and other stakeholders as Congress examined legislative reforms in other key areas, including diagnostics and laboratory developed tests, cosmetics, and over-the-counter drugs.

Before taking his Senate role, Wade served for more than five years as Associate Chief Counsel within the FDA’s Office of Chief Counsel. He was responsible for providing legal advice to the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Commissioner (OC) on a wide range of issues. While at FDA, he also helped to develop and implement the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013—both significant reforms to FDA’s regulatory authorities.

Contact:Read more about Wade AckermanEmail

There are two papers in the May 15 volume of the Annals of Internal Medicine that discuss digital health applications and are illustrative of the topics being considered by physicians as they evaluate the adoption and impact of digital solutions.  These papers serve as examples of the active dialogue taking…
Continue Reading What physicians are reading about digital health

On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals.  Here are some key takeaways from that webinar:

  • Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage,

…
Continue Reading Key Takeaways from Covington’s Webinar about Digital Health Associated with Pharmaceuticals

On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft guidances announce the agency’s initial interpretation of the health software provisions enacted as part of last year’s 21st Century Cures Act (the “Cures Act”).

Given the rapid pace of digital health innovation across the life sciences, technology and health care sectors, FDA guidance on these topics is critical. Here are a few key takeaways from the draft guidances:

  • FDA’s initial interpretation of the Cures Act provision related to clinical decision support (CDS) software may lead to a fairly narrow carve-out—in other words, many cutting-edge CDS software functions could remain subject to FDA regulation.
  • FDA’s draft guidances do not directly address dynamic digital health solutions, such as those that incorporate machine learning, artificial intelligence (AI), or blockchain.
  • FDA has proposed an enforcement discretion approach for decision support software aimed at patients that generally parallels the regulatory approach for CDS software aimed at clinicians, even though patient decision software was not addressed directly in the Cures Act.
  • Consistent with the Cures Act, FDA’s draft guidances reflect that many of the software functions that were previously subject to FDA enforcement discretion (i.e., not actively regulated as devices) no longer meet the definition of “device.”
  • Significant for pharmaceutical companies, CDER joined one of the draft guidances, and that draft guidance makes clear that other FDA requirements may apply to digital health products disseminated by or on behalf of a drug sponsor beyond those outlined in the draft guidance.

FDA’s regulatory approach has a significant impact on the investment in and development of digital health solutions across the digital health ecosystem. Stakeholders should consider submitting comments to the agency to help shape the direction of FDA’s final guidances on these topics.Continue Reading FDA Outlines Updated Approach to Regulating Digital Health Technologies

On November 16, 2017, the Food and Drug Administration (“FDA” or the “Agency”) will hold a public hearing on a proposed approach for sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device. FDA will accept comments to the docket until January 15, 2018.
Continue Reading Pharmaceutical Digital Health Innovators Take Note: FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs

Digital Health

In the second of a three-part series, Covington’s global cross-practice Digital Health team considers some additional key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle.

Key Commercial…

Continue Reading Digital Health Checkup (Part Two): Key Commercial Questions When Contracting for Digital Health Solutions

Digital Health

In the first of a three-part series, Covington’s global cross-practice Digital Health team answers key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle.

Key Regulatory Questions About…

Continue Reading Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One)

On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month.

The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation…
Continue Reading FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan