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Scott Cunningham is a member of the firm’s Food and Drug practice group. He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies. Mr. Cunningham has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations; Orphan Drug; pediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; SEC disclosure; and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.
Mr. Cunningham also has an active pro bono practice where he regularly serves as a Guardian ad Litem representing children in neglect & abuse and child custody cases.
- Represented major pharmaceutical company working with the FDA to avoid market entry of unsafe or ineffective generic products. This representation included developing and filing petitions with the agency and developing a potential litigation strategy.
- Assisted early-stage medical device company in developing compliance policies for marketing and promotion, interactions with health care professionals, conflicts of interest, and providing scientific research and educational grants.
- Represented manufacturer of a biological product in an effort to reverse a negative coverage decision by a major health insurance organization.
Pro Bono
- Represented boys aged nine and fourteen as Guardian ad Litem in child custody dispute between biological parents in Washington, D.C. Superior Court.
- Defended Maryland citizen in criminal drug possession charges in Maryland criminal court.
- Represented five year old girl as Guardian ad Litem in neglect and abuse proceedings in Washington, D.C. Superior Court.
July 23, 2020, Covington Alert
FDA announced this week that it intends to extend its enforcement discretion policy regarding investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products through May 2021. In light of the COVID-19 emergency, manufacturers will have six additional months after the initial November 2020 deadline to prepare and ...
April 2, 2020, Covington Alert
On March 27, the U.S. Food and Drug Administration (FDA) updated its guidance entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (Updated Guidance).
April 1, 2020, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
March 19, 2020, Covington Alert
The U.S. Food and Drug Administration (FDA) released guidance on March 18, 2020 entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (Guidance).1 The Guidance comes at a critical time, as clinical trial sponsors, investigators, and Institutional Review Boards (IRBs) grapple with the measures needed to ensure the ...
August 2020
Recapture of Excess COVID-19 Payroll Tax Credits Addressed in New Regs Recapture of Excess COVID-19 Payroll Tax Credits Addressed in New Regs 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 ...
February 24, 2020, Covington Alert
This e-alert reviews trends emerging from warning letters and untitled letters concerning product advertising and promotion issued in 2019 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) of the ...
January 21, 2020, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
December 20, 2019, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
October 17, 2019, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
September 12, 2019, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics. In July and August, the Office of Prescription Drug Promotion (OPDP) posted enforcement letters on FDA’s website.
July 18, 2019, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
April 5, 2019
NEW YORK—Covington represented IFM Tre, Inc. in its sale to Novartis for a $310 million upfront cash payment and up to $1.265 billion in milestone payments (for a total of $1.575 billion). IFM Tre develops chemically distinct systemic, gut-directed, and CNS-penetrant drug candidates to address several indications triggered by NLRP3, including metabolic, ...
March 14, 2019, Covington Alert
This alert is part of a series of alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
January 31, 2019, Covington Alert
This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2018 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality ...
November 20, 2018, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available U.S. Food and Drug Administration (FDA) enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
September 19, 2018, Covington Alert
This alert is part of a series of alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
July 27, 2018, Covington Alert
On July 11, 2018, the U.S. Food and Drug Administration (FDA or the Agency) made available a suite of six scientific draft guidance documents on human gene therapy (GT) products.
FDA Regulation of Medical Devices
June 12, 2018, U.S. Healthcare Compliance Certification Program
March 9, 2018, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
How is the FDA Approaching Regulation under the Trump Administration?
February 14, 2018, Biocom Lunch & Learn
February 9, 2018, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
January 26, 2018, Covington Alert
This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2017 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation and Research ...
January 9, 2018, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
December 12, 2017, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
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 ...
October 10, 2017, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
September 20, 2017, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
August 10, 2017
NEW YORK—Covington is representing IFM Therapeutics in its sale to Bristol Myers Squibb for $300 million in cash and the right to receive contingent payments upon achievement of specified milestones that could total in excess of $1 billion for each of its two oncology programs. Prior to closing, IFM will spin off its inflammation program to a newly-formed ...
Regenerative Medicine and Combination Products
February 1, 2017, 21st Century Cures Act Webinar Series
January 9, 2017, Covington Alert
This alert reviews trends emerging from the warning and untitled letters issued in 2016 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER). No warning or untitled letters concerning promotion were issued this year by the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation ...
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 ...
January 2016, Covington Alert
This e-alert is part of a series of alerts summarizing publicly-available FDA enforcement letters relating to the advertising and promotion of prescription drugs, medical devices, and biologics. This alert reviews warning and untitled letters issued in 2015. In 2015, FDA’s Office of Prescription Drug Promotion (OPDP) posted the following letters on FDA’s ...
Recent Legislative and Regulatory Developments: Drug Track-and-Trace, Clinical Trial Disclosure, and 21st Century Cures
April 1, 2015, Life Sciences Essentials Webinar Series
January 23, 2015, Covington E-Alert
September 2, 2014, Covington E-Alert
August 5, 2014, Covington E-Alert
July 2, 2014, Covington E-Alert
June 19, 2014, Covington E-Alert
June 4, 2014, Covington E-Alert
April 30, 2014, Covington E-Alert
April 25, 2014, Covington E-Alert
April 9, 2014, Covington E-Alert
January 16, 2014, Covington E-Alert
December 2, 2013, Covington E-Alert
November 20, 2013, Covington E-Alert
November 12, 2013, Covington E-Alert
11/07/2013
WASHINGTON, DC, November 7, 2013 — Salix Pharmaceuticals, Ltd., and Santarus, Inc. announced today that the companies have entered into a merger agreement where Salix will acquire all of the outstanding stock of Santarus for $32 in cash per share, for a total value of approximately $2.6 billion. Covington & Burling LLP is advising Salix on both the acquisition ...
August 28, 2013, Covington E-Alert
March 18, 2013, Covington E-Alert
December 7, 2012, Covington E-Alert
Covington Advises Meda on Acquisition of Jazz Pharmaceuticals’ Women’s Health Products
September 6, 2012
LONDON, 06 September, 2012 — Covington & Burling LLP acted as legal advisers to Meda in an agreement with Jazz Pharmaceuticals to acquire a portfolio of six pharmaceutical products for women for $95 million in cash. The largest and most important product in the portfolio is Elestrin, a patented product with sales of almost 100 MSEK, that doctors prescribe for ...
September 2012, Scrip Regulatory Affairs
SFDA Issues Proposed Regulations for the Administration of Inspections of Foreign Drug Manufacturers
September 2012, Covington E-Alert
August 10, 2012, Covington E-Alert
June 11, 2012
WASHINGTON, DC, June 11, 2012 — Chambers USA recognized 106 individual Covington & Burling lawyers and 46 Covington practice areas in the 2012 Chambers USA: America’s Leading Lawyers for Business guidebook released on June 7, 2012. Many of the 106 Covington lawyers ranked by Chambers USA were recognized in multiple categories, resulting in a total of 131 ...
April 24, 2012, Covington E-Alert
February 7, 2012, Covington E-Alert
January 19, 2012, Covington E-Alert
January 9, 2012, Covington E-Alert
November 18, 2011, Covington E-Alert
June 22, 2011, Covington E-Alert
June 10, 2011
WASHINGTON, DC, June 10, 2011 — Covington & Burling LLP received 123 individual mentions and 45 practice mentions in Chambers USA 2011. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...
May 11, 2011, Covington E-Alert
September 21, 2010
NEW YORK, September 21, 2010 — Prestige Brands Holdings, Inc. has announced that it has entered into a definitive agreement to acquire 100% of the stock of Blacksmith Brands Holdings, Inc., a portfolio company of Charlesbank Capital Partners, for $190 million in cash. Covington & Burling LLP advised Charlesbank on the transaction, which is expected to close in ...
June 3, 2010, Covington E-Alert
April 28, 2010, Covington E-Alert
Jan 28th, 2010, Covington E-Alert
11/2/2009
NEW YORK, NY, November 2, 2009 — Charlesbank Capital Partners, LLC has announced the formation of Blacksmith Brands Inc. with the acquisition of five over-the-counter consumer products brands from McNEIL-PPC, Inc. Covington & Burling LLP advised Charlesbank on the transaction. The brands acquired by Blacksmith include: Efferdent denture cleaner; Effergrip ...
Covington Advises Procter & Gamble on $3.1B Sale of Global Pharmaceuticals Business to Warner Chilcott
8/24/2009
NEW YORK, NY, August 24, 2009 — Procter & Gamble today announced the sale of its global pharmaceuticals business to Warner Chilcott Ltd. Covington & Burling LLP advised Procter & Gamble on the transaction. Procter & Gamble is a leading global branded products company, with one of the strongest portfolios of quality, leadership brands in consumer health and ...
Covington Promotes 12 Lawyers to the Partnership
10/1/2008
WASHINGTON, DC, October 1, 2008 — Covington & Burling LLP today announced that 12 of its lawyers have been elected to the firm’s partnership. These new partners are resident in four of the firm’s offices and practice in the litigation, corporate/tax, and regulatory fields. Timothy Hester, chair of the firm’s management committee, commented: “These young and ...
Covington Advises Procter & Gamble On Sale of ThermaCare
7/17/2008
NEW YORK, NY, July 17, 2008 — Wyeth Consumer Healthcare, a division of Wyeth, announced that it signed an agreement to purchase ThermaCare, a leading over-the-counter heat wrap, from Procter & Gamble. Covington & Burling LLP advised Procter & Gamble on the transaction. Introduced in the United States in 2002, ThermaCare Heat Wraps use heat therapy to relieve ...
Covington Advises Pfizer on Acquisition of Serenex
3/3/2008
NEW YORK, NY, March 3, 2008 — Pfizer Inc. announced today that it has entered into an agreement to acquire Serenex Inc., a privately held biotechnology company. Covington & Burling LLP advised Pfizer on the transaction. Pfizer, the world’s largest research-based biomedical and pharmaceutical company, discovers and develops innovative medicines to treat and help ...
1/2/2008
NEW YORK, NY, January 2, 2008 — Pfizer announced on December 31 that it has completed the cash tender offer for the outstanding shares of common stock of Coley Pharmaceutical Group, Inc., a publicly-held biopharmaceutical company specializing in vaccine adjuvant technology and a new class of immunomodulatory drug candidates designed to fight cancers, allergy and ...
Covington Advises Pfizer in Acquisition of BioRexis
February 1, 2007
NEW YORK, NY, February 1, 2007 — Covington & Burling LLP advised Pfizer in the acquisition of BioRexis, a privately held biopharmaceutical company. The transaction is expected to close in the first or second quarter of 2007. The financial terms of the transaction were not disclosed.BioRexis is developing long-acting GLP-1 receptor agonists for the potential ...
Publication Policy Compliance: Adhering to Legal, Regulatory, and Industry Guidelines
September 11, 2006, Pharmaceutical Educational Associates, Webinar
June 5, 2006, Covington E-Alert
FDA Disclosure in an SEC World
June 29, 2005, Drug Information Association Annual Conference, Washington, DC
- Chambers USA - America's Leading Business Lawyers, Healthcare: Pharmaceutical/Medical Products Regulatory (2012)
- Washington DC Super Lawyers, FDA (2013-2014)