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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 16 years of experience in private practice and positions within the FDA and on Capitol Hill, Mr. Ackerman 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 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, Mr. Ackerman 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, Mr. Ackerman 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, Mr. Ackerman 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.
- Advised global healthcare company GSK on FDA regulatory components of the company's $300 million equity investment and collaboration with genetic testing and data science company 23andMe -- a collaboration focused on R&D of new medicines, using human genetics as the basis for discovery.
Previous Experience
- U.S. Senate Committee on Health, Education, Labor, and Pensions, Senior FDA Counsel
- U.S. Food and Drug Administration, Associate Chief Counsel
March 2021
As the legal, regulatory, and commercial implications of coronavirus COVID-19 continue to evolve, our lawyers and advisors are helping clients navigate the complex considerations that companies around the world are facing and develop plans and strategies in response. Reach out to our COVID-19 task force at COVID19@cov.com. Below is a compendium of resources ...
HHS Publishes Notice Exempting Devices from Premarket Review in Final Days of Trump Administration
February 2, 2021, Covington Alert
On January 15, the final Friday of the Trump administration, the Department of Health and Human Services (“HHS”) published in the Federal Register a notice permanently exempting or proposing to exempt 101 medical devices that previously required a premarket clearance under section 510(k) of the Food, Drug & Cosmetic Act (“FDCA”). Under the notice, seven class I ...
December 14, 2020, Inside Health Policy
Wade Ackerman spoke with Inside Health Policy about the HHS' decision to remove laboratory-developed tests from FDA oversight. Mr. Ackerman says laboratory-developed test regulation has long been a hot topic among stakeholders. “The pandemic put the nation's attention on testing, and the HHS' statement set in motion LDT regulation being an even more high-profile ...
Burr, in line to lead Senate Republicans’ health strategy, has a long history of antagonizing the FDA
December 1, 2020, STAT
Wade Ackerman is quoted in STAT regarding Senator Richard Burr’s public health policies and his bipartisan efforts. Mr. Ackerman says, “He compromises. He actually is very good to negotiate with on FDA issues because he and his staff are so knowledgeable, and do want to move forward bipartisan policy.”
November 9, 2020, Covington Alert
Now that former Vice President Biden has been projected to win the 2020 U.S. Presidential Election, expect the transition to commence from the Trump Administration to a Biden Administration. Control of the U.S. Senate remains in the balance with two runoff elections in Georgia on January 5, but either way, the Senate majority will be razor thin and hence less ...
November 2, 2020, Medtech Insight
Wade Ackerman is quoted in Medtech Insight regarding the impact of the 2020 presidential election on FDA regulations. Mr. Ackerman says the outcome of the election may have a significant effect on the leadership of U.S. FDA, with either winner bringing marked differences in policies and priorities. In a note to clients, he outlined some differences medtech ...
October 28, 2020, Covington Alert
The outcome of the national elections next week will have consequential implications at the U.S. Food and Drug Administration (FDA). The election may affect the composition of FDA’s leadership team, and stakeholders can expect differences in policies and priorities between a second Trump Administration and a new Biden Administration. Control of the U.S. Senate ...
September 28, 2020, Covington Digital Health
In a new post on the Covington Inside Privacy blog, our colleagues discuss the passage of California’s AB 713, a bill that creates a new healthcare-related exemption under the California Consumer Privacy Act of 2018 (“CCPA”) for certain information that has been deidentified in accordance with the Health Insurance Portability and Accountability Act of 1996...… ...
August 25, 2020, Covington Alert
On August 19, the Department of Health and Human Services (HHS) announced a new policy concerning laboratory developed tests (LDTs). Under this policy, HHS has determined that the Food and Drug Administration (FDA) must engage in notice-and-comment rulemaking before requiring premarket review of LDTs. Depending on the next steps from HHS and FDA, this ...
August 18, 2020, Covington Digital Health
On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software. The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which ...
August 13, 2020, Covington Digital Health
Our colleagues at the Inside Privacy blog have summarized a proposed bill in California (the Genetic Information Privacy Act) that would impose certain privacy obligations on direct-to-consumer genetic testing companies that go beyond the California Consumer Privacy Act. This summary may be of interest to entities that process genetic data in California.… ...
June 12, 2020, BioSpace
Wade Ackerman is quoted in BioSpace regarding the decentralization of clinical trials in the pharmaceutical industry. Mr. Ackerman says the “all hands on deck” approach to the pandemic by Congress and the FDA set the stage for clinical trial innovation. “It has set up a lot of conversations about where telehealth is, and where it will be six months from now,” he ...
Wade Ackerman and Amy Toro Named Top Health Care Lawyers
June 8, 2020
LOS ANGELES—Daily Journal has named Wade Ackerman and Amy Toro to its 2020 Top Health Care Lawyers, a recognition of the leading California lawyers who specialize in health care litigation, transactions, and counselling. Mr. Ackerman, a partner in our Los Angeles office, advises clients on complex FDA issues that require coordinated legal, regulatory, and public ...
June 4, 2020, Covington Alert
Today, FDA issued updates to its guidance document "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),"("Temporary Policy") and related guidance document, that primarily provide more detailed information about potential ethanol sources for companies seeking to prepare hand sanitizer or ...
May 15, 2020, Covington Digital Health
The following guidance could be relevant to manufacturers of software as a medical device (SaMD). The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent ...
May 14, 2020, Covington Alert
The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance in manufacturing during, or in advance of, a declared public health emergency. On May 6, ...
April 23, 2020, Daily Journal
Wade Ackerman and Scott Danzis spoke with the Daily Journal about their work with clients on emergency use authorization (EUA) requests. Mr. Ackerman says of the firm, “One of the things I appreciate about being in California, but also part of this firm that’s deeply connected with D.C., is that we have connectivity with what’s going on at FDA and on the ...
April 18, 2020, Covington Digital Health
On April 14, 2020, FDA issued a direct-to-final guidance outlining its “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The guidance intends to “expand the availability of digital health therapeutic devices” – possibly the first time FDA has used such term ...
April 5, 2020, Covington Alert
On March 27, 2020, Congress passed and the President signed into law H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). Recognizing the critical supply chain risks posed by the COVID-19 pandemic, Congress included multiple provisions in the CARES Act that aim to mitigate and prevent future medical product shortages (these ...
March 27, 2020, Covington Digital Health
The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges. The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19. The Centers for Disease ...
March 27, 2020, Covington Alert
On March 27, 2020, Congress passed H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Subtitle F of the CARES Act would significantly change FDA’s regulations of over-the-counter (OTC) monograph drugs subject to OTC Drug Review. Congress had introduced earlier versions of the bill, with the latest bill, S. 2740 – Over-the-Counter ...
March 18, 2020, Covington Alert
To assist companies that are developing technology solutions to help predict, mitigate or contain the spread of COVID-19, our cross-practice digital health team has put together a checklist of considerations to keep in mind. For additional guidance, please visit our COVID-19 Legal and Business Toolkit or reach out to us at COVID19@cov.com.
March 11, 2020, Covington Alert
FDA has reopened the comment period indefinitely for its public hearing on products containing cannabis or cannabis-derived compounds.In doing so, FDA is seeking scientific data and information on cannabis and cannabis-derived compounds, particularly cannabidiol (CBD). On May 31, 2019, FDA hosted a public hearing on “Scientific Data and Information About ...
January 2020
Covington has created a list of Top 10 Questions for Ideation of Digital Health Solutions that can help lawyers contribute to the digital health ideation process. Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. "Ideation" is part of that process and involves the rapid ...
November 26, 2019, Covington Digital Health
This is the tenth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: What are the priorities for the solution?… Continue Reading
November 25, 2019, Westlaw Journal Medical Devices
October 15, 2019, Covington Digital Health
This is the fourth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: what data will be needed to substantiate the offering?… Continue Reading
October 8, 2019, Covington Digital Health
On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ...
September 24, 2019, Covington Digital Health
Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. “Ideation” is the part of that process and involves the rapid identification and creation of ideas for digital health solutions, which are then prototyped and tested. Covington has created a Top 10 Questions for Ideation of ...
June 25, 2019, Covington Digital Health
Last week, Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) introduced the Protecting Personal Health Data Act (S. 1842), which would provide new privacy and security rules from the Department of Health and Human Services (“HHS”) for technologies that collect personal health data, such as wearable fitness trackers, social-media sites focused on health ...
FDA Announces Public Workshop on Using Randomized Clinical Trials to Generate Real-World Evidence
June 10, 2019, Covington Digital Health
Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in ...
April 25, 2019, Covington Digital Health
On April 19, 2019, the Department of Health and Human Services (HHS) announced a 30-day extension to the comment period for two rules proposed by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), originally published on March 4, 2019. These rules, discussed...… Continue ...
2019, American Bar Association
Our cross-disciplinary Internet of Things initiative contributed to the ABA's first book on IoT, The Internet of Things: Legal Issues, Policy, & Practical Strategies. Laura Kim and Jennifer Johnson authored the chapter “U.S. Regulatory Framework for IoT,” with contributions from Sarah Wilson (product safety); Wade Ackerman, Elizabeth Guo, Christopher Hanson, ...
March 7, 2019, Covington Digital Health
On March 4, 2019, the Department of Health and Human Services (HHS) published two proposed rules to improve patient access to personal health data. The two rules, issued by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), are intended to increase interoperability...… ...
January 22, 2019, Covington Digital Health
Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some ...
October/November 2018, Update (reprinted with permission from FDLI)
July 31, 2018, Medtech Insight
Wade Ackerman is quoted in Medtech Insight regarding the FDA’s software pre-certification program and what that means for device and digital health firms interested in getting new products to the market. Mr. Ackerman says, "The agency has been transparent in that it is considering various legal mechanisms available to the agency to establish the program – ...
July 30, 2018
SILICON VALLEY—Covington advised GlaxoSmithKline on its multi-year collaboration with and $300 million equity investment in 23andMe. GSK will become 23andMe’s exclusive collaborator for drug target discovery programs. The collaboration will focus on research and development of innovative new medicines and potential cures using human genetics as the basis for ...
June 26, 2018, Covington Digital Health
Earlier this year, President Trump signed into law the Bipartisan Budget Act of 2018 (BBA), which incorporates provisions from the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 and improves access to telehealth services in Medicare Advantage. Pub. L. No. 115-123. Among other provisions impacting Medicare ...
May 7, 2018, Covington Digital Health
On April 26, Commissioner Gottlieb addressed the agency’s progress on FDA’s Digital Health Innovation Action Plan and announced several additional steps the agency is taking to advance the potential benefits of digital health. Here is a recap of the key updates: (1) Launch of New FDA Program to Apply Digital Health to Drugs As our...… Continue Reading
March 9, 2018, Covington Digital Health
On March 6, 2018, CMS announced the MyHealthEData initiative, which aims to give patients easier access to and control over their medical records. Announcing the initiative, CMS Administrator Seema Verma laid out a future where individuals will have access to their health data wherever they go and be able to share data with the push...… Continue Reading
February 26, 2018, Covington Digital Health
Inflection Point for IoT In a relatively short amount of time, the adoption of the Internet of Things (IoT) and its applications— from smart cars to the myriad of interconnected sensors in the General Service Administration building reminiscent of HAL 9000 from 2001: A Space Odyssey— has rapidly proliferated, providing significant opportunities and benefits. ...
February 21, 2018, Covington Digital Health
As 2018 gets underway, EHR vendors and users continue to face challenges and uncertainty. There are three legal and regulatory issues in particular that we think are important to watch over the next 10 months: Moving to the 2015 Edition Certification Criteria. Although CMS will not require hospitals or eligible professionals to use 2015 CEHRT...… Continue ...
How is the FDA Approaching Regulation under the Trump Administration?
February 14, 2018, Biocom Lunch & Learn
February 6, 2018
LOS ANGELES—The Los Angeles Business Journal recognized Wade Ackerman and Aaron Lewis in its second annual list of the most influential diverse lawyers in Los Angeles. The list recognizes 50 "stellar diverse lawyers in the LA region." In Mr. Ackerman’s profile, the Business Journal emphasized his work in the FDA regulatory space. The profile noted that “with a ...
January 24, 2018, Covington Alert
As we begin 2018, the cosmetic industry marketing products in the United States faces a range of legal and regulatory considerations – from labeling and marketing claims to ingredient safety and environmental issues. This alert for our cosmetic clients analyzes federal regulatory activities in 2017 and summarizes key issues to consider for 2018, including ...
Regulating the digital health revolution: When does it help or hinder innovation?
January 9, 2018, Digital Medicine & Medtech Showcase
November 21, 2017, Covington Alert
In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory framework” for regenerative medicine products. On November 16, 2017, FDA issued four guidance documents outlining certain aspects of that framework. This alert summarizes each of the guidance documents and highlights ...
November 7, 2017, Covington Alert
On August 18, 2017, President Donald Trump signed into law the FDA Reauthorization Act of 2017 (FDARA). This law, containing nine titles, reauthorizes and amends the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.
November 2017, Journal of Medical Device Regulation
October 11, 2017, Covington Alert
On Monday, October 9, 2017, California Governor Jerry Brown signed into law Senate Bill 17 (SB 17), establishing substantial new reporting and notification requirements in California for prescription drug manufacturers related to drug pricing. California is the latest of several states to enact legislation related to drug pricing. This alert, prepared by ...
September 20, 2017, Covington Alert
On August 18, 2017, President Trump signed H.R. 2430, the FDA Reauthorization Act of 2017, which became Public Law No. 115-52 (“FDARA”). Principally, FDARA reauthorizes the Food and Drug Administration (“FDA” or “the agency”) user fee programs, including the Medical Device User Fee Amendments, the Prescription Drug User Fee Amendments, the Biosimilars User Fee ...
Regulatory and Legislative Blockbuster: Where Are We Headed Under the Trump Administration?
September 14, 2017, ABA Life Sciences Legal Summit
Digital Health Technologies for Combination Products and Beyond: Development and Regulation
June 18, 2017, DIA 2017 Annual Meeting
U.S. FDA's New Game Plan For Digital Health
June 16, 2017, Medtech Insight
Wade Ackerman is quoted in a Medtech Insight article regarding FDA's regulatory strategy in relation to digital health. "While Congress addressed some aspects of FDA's regulation of health software in the 21st Century Cures Act last year, the digital landscape continues to evolve rapidly," Ackerman says. "FDA's intent to outline a new digital health innovation ...
The 5 year reauthorization of PDUFA, MDUFA, BsUFA, and GDUFA
June 7, 2017, 20th Annual Orange County Regulatory Affairs (OCRA) Educational Conference
21st Century Cures Act
June 7, 2017, 20th Annual Orange County Regulatory Affairs (OCRA) Educational Conference
May 9, 2017, MedTech Insight
Wade Ackerman is quoted by MedTech Insight in an article covering the May 5 Food, Drug and Law Institute's annual meeting in Washington. Ackerman provided his insights on the hiring trajectory for those individuals tasked to implement the 21st Century Cures Act, and noted that the funds can be viewed as having broad applications for hiring. Ackerman stated, ...
May 5, 2017
LOS ANGELES—The California Life Sciences Association (CLSA) has named Covington partner Wade Ackerman to its board of directors. Founded in 2015, CLSA works closely with industry, government, academia and other stakeholders to shape public policy, drive business solutions, and grow California’s life sciences innovation ecosystem. CLSA serves biotechnology, ...
Designing Clinical Trials in a 21st Century Cures Paradigm
February 14, 2017, BIO CEO and Investor Conference
Regenerative Medicine and Combination Products
February 1, 2017, 21st Century Cures Act Webinar Series
Device and Health Software Provisions
January 25, 2017, 21st Century Cures Act Webinar Series
Drugs and Biological Product Provisions
January 18, 2017, 21st Century Cures Act Webinar Series
January 17, 2017, Covington Alert
On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible ...
January 13, 2017, Medtech Insight
Wade Ackerman participated at the Medtech Showcase and is quoted in a Medtech Insight article regarding the launch of AdvaMed Digital and the increased focus on medtech and digital health. According to Ackerman, having the dedicated sector within AdvaMed will be a positive for future digital-health policy development.
J.P. Morgan Notebook Day 1: PCSK9 Face-Off, Teva's Slowed Growth, Merck's Keytruda Wins, Lilly's CDK4/6 Hopes And More
January 10, 2017, The Pink Sheet
Wade Ackerman participated at the Biotech Showcase and is quoted by The Pink Sheet in an article regarding the increased use of real-world evidence by FDA following the passage of the 21st Century Cures Act. According to Ackerman, FDA will be running a pilot program to evaluate the potential of real-world evidence to support supplemental indications and satisfy ...
Opening Panel: State of the Medtech Industry
January 10, 2017, Medtech Showcase
Lunch Plenary Session: The Real-World Evidence Revolution: Finding Value and Relevance through the Stakeholder Perspective
January 9, 2017, Biotech Showcase
An Overview of Key FDA Provisions
January 5, 2017, 21st Century Cures Act Webinar Series
December 22, 2016, Covington Alert
On December 13, 2016, President Obama signed H.R. 34, the 21st Century Cures Act, which became Public Law No. 114-255 (“the Act”). Its enactment represents the culmination of a multi-year bipartisan legislative process spearheaded on the House side by Energy and Commerce Committee Chairman Fred Upton, Ranking Member Frank Pallone, and Rep. Diana DeGette and on ...
21st Century Cures Act
December 21, 2016, Food and Drug Law Institute On-Demand Webinar
Connecting with Policymakers: Lobby Day & Beyond
November 17, 2016, IFRA North America Annual Business Meeting
Cosmetics, Congress and the FDA- what’s happening?
November 10, 2016, Personal Care Products Council 2016 Emerging Issues Conference
The Political Impact of the Election: How The Results Will Impact Our Industry
November 2-3, 2016, The Life Sciences Summit
Wade Ackerman moderated the closing plenary session, “The Political Impact of the Election: How Results Will Impact Our Industry,” at the Life Sciences Summit. The Life Sciences Summit is an early-stage investor and business development conference for emerging companies and academic innovators. The objective of the meeting is to connect emerging companies with ...
Ten Things I’d Change About DSHEA
October 26-29, 2016, The Council for Responsible Nutrition’s Annual Symposium for the Dietary Supplement Industry
October 28, 2016, FDA Week
Wade Ackerman spoke at a DIA conference on October 24 and is quoted in an FDA Week article regarding combination product reform. According to Mr. Ackerman, there has been strong bipartisan support for 21st Century Cures and Medical Innovation bills. However, if combination product language does not get passed in this Congress, Ackerman also pointed to the FDA ...
Combination Products on Capitol Hill
October 24-26, 2016, DIA Combination Products Conference 2016: Current, Evolving, and Future Pathways
Wade Ackerman participated in a session entitled: "Combination Products on Capitol Hill" at DIA’s Combination Products 2016 conference. The session’s panel provided an overview of recent bills from the perspectives of industry, the agency, and congressional staffers; discussed the Hill’s interests in legislation; and explored the possible fates of these bills or ...
Short Course: Digital Health Technologies for Combination Products and Beyond: Development and Regulation
October 24-26, 2016, DIA Combination Products Conference 2016: Current, Evolving, and Future Pathways
Wade Ackerman and Christina Kuhn taught the short course “Digital Health Technologies for Combination Products and Beyond: Development and Regulation” at DIA’s Combination Products 2016 conference. When it comes to the regulatory path to market for digital health technologies that touch upon drug products, much attention has been paid to FDA’s device center, but ...
Regulation of Diagnostics: Trends and Developments
September 29, 2016, BIO IP & Diagnostics Symposium
Health Hires: Government Attorneys Join Covington, Foley
September 9, 2016, Law360
Wade Ackerman and Denise Esposito are quoted in a Law360 article regarding Ackerman’s recent arrival as a partner in the firm’s Food, Drug, and Device practice. According to Ackerman, he’d like to serve as bridge between Washington, D.C., and Los Angeles for the firm. For a food and drug attorney, Covington is the place to go, given its “long history of having a ...
September 1, 2016, The Recorder
Wade Ackerman and Robyn Polashuk are quoted in a Recorder article regarding the growth of the firm’s LA office, which includes Ackerman’s recent arrival. "We're in a period of unprecedented change in the way products are regulated, and a lot of companies are on the West Coast,” said Ackerman. Commenting on West Coast business, Polashuk says, “It hasn't been, ...
August 31, 2016
LOS ANGELES—Wade Ackerman has joined Covington as a partner in its Food, Drug, and Device practice, resident in Los Angeles. Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health, Education, Labor & Pensions Committee. In this role, he has been intimately involved in legislative initiatives, oversight hearings, and other Senate ...
Regulatory Conundrums – Should We Be Left To Our Own Devices?
August 11, 2016, Precision Medicine Leaders Summit
FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development?
June 26-30, 2016, DIA 2016 Annual Meeting
Building Personalized Medicine Policy: The 21st Century Cures and Healthier Americans Legislative Proposals
June 6-9, 2016, 2016 BIO International Convention
Looking to the Future: Legislative and Policy Perspectives
November 17-18, 2015, ECRI Institute's 22nd Annual Conference on the Use of Evidence in Policy and Practice, Cancer Care Delivery in a Rapidly Changing Healthcare System, Co-sponsored by the National Cancer Institute
Regulation of Combination Products in the 21st Century
June 14-18, 2015, DIA 2015 51st Annual Meeting
Congressional Staff Panel
May 4-5, 2015, American Clinical Laboratory Association 20th Annual Meeting
The US House of Representatives’ 21st Century Cures Initiative and the US Senate’s Medical Innovation Working Group
April 20-21, 2015, 2015 Food and Drug Law Institute Annual Conference
Capitol Hill Perspectives on the Cost and Complexities of Drug Policy
April 14, 2015, 2015 Pharmaceutical Care Management Association PBM Forum
Congressional Leadership in Innovation and Regulation
February 23, 2015, Brookings Institution The Future of Medical Device Safety and Innovation
The Sunscreen Innovation Act
January 29, 2015, Food and Drug Law Institute Webinar
- Daily Journal, "Top Health Care Lawyers" (2020)
- Named one of the most influential diverse lawyers in Los Angeles by the Los Angeles Business Journal (2018).
- Legal 500 US, Health Care - Life Sciences (2017)
COVID-19: Legal and Business Toolkit
We are helping clients around the world navigate this evolving, complex situation.