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Gary Messplay specializes in advising life science companies on regulatory and compliance matters. A partner in our FDA and Life Sciences practice, Gary represents leading pharmaceutical and medical device companies in a broad range of regulatory and compliance matters. Gary's clients include large multinational drug and device companies, as well as emerging companies.

Gary represents clients in matters relating to the regulation and commercialization of drugs, biologics, medical devices, food, cosmetics and tobacco by the Food and Drug Administration, the Department of Health and Human Services, the Department of Agriculture, the Drug Enforcement Administration, and other federal and state agencies. He counsels large multinational product manufacturers, as well as mid-size and emerging companies, on regulatory and compliance matters that involve the FDA, the HHS Office of Inspector General and other government agencies.

Gary has substantial experience in advising clients on all aspects of product launches and commercialization; leading product and compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; and managing competitor disputes.

In addition, Gary regularly advises clients on complex regulatory and administrative law matters; compliance; advertising and promotion; specialty pharmacy programs; litigation; legislative initiatives; and due diligence in financings, mergers and acquisitions. He also advises clients on matters relating to healthcare fraud and abuse, clinical trials, drug safety issues, recalls, product approval issues, drug and device quality and manufacturing issues, and life cycle management. Counseling clients in responding to government and congressional investigations, as well as in transactional work related to FDA- and USDA-regulated products, is also a part of Gary's practice.

Previously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.

A frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by Super Lawyers.

Full Bio

Credentials

District of Columbia

Indiana


Super Lawyers, 2014, 2015 & 2016

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Recognition


Super Lawyers, 2014, 2015 & 2016

Matters

Developed customized, comprehensive healthcare compliance programs for numerous drug and medical device companies.

Served as outside general counsel to specialty pharmaceutical companies and emerging drug and device companies.

Led significant multi-year investigation for a large pharmaceutical company involving complex data integrity issues related to their bioanalytics laboratory.

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Matters

Developed customized, comprehensive healthcare compliance programs for numerous drug and medical device companies.

Served as outside general counsel to specialty pharmaceutical companies and emerging drug and device companies.

Led significant multi-year investigation for a large pharmaceutical company involving complex data integrity issues related to their bioanalytics laboratory.

Advised numerous drug and device companies related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.

Conducted a significant number of compliance investigations on behalf of drug and device companies, including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling.

Represented Board of Directors of publicly traded pharmaceutical company in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute.

Advised drug and device companies on all aspects of compliance with their corporate integrity agreements.

Advised numerous pharmaceutical companies on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.

Successfully represented a specialty pharmaceutical company in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.

Represented drug and device companies in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.

Advised drug and device companies related to clinical trial regulatory and compliance issues.

Assisted pharmaceutical companies in developing and implementing specialty pharmacy programs.

Represented drug and device companies in connection with adverse FDA inspections, including responding to 483s and warning letters.

Represented drug and device companies in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements.

Led numerous regulatory and compliance due diligence teams in drug, device, tobacco and food transactions.

Represented drug and device companies in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation.

Advised drug, biotechnology, device, food and tobacco companies on legislative matters including drafting and commenting on legislation.

Matters

Developed customized, comprehensive healthcare compliance programs for numerous drug and medical device companies.

Served as outside general counsel to specialty pharmaceutical companies and emerging drug and device companies.

Led significant multi-year investigation for a large pharmaceutical company involving complex data integrity issues related to their bioanalytics laboratory.

See more
Icon close

Close

Matters

Developed customized, comprehensive healthcare compliance programs for numerous drug and medical device companies.

Served as outside general counsel to specialty pharmaceutical companies and emerging drug and device companies.

Led significant multi-year investigation for a large pharmaceutical company involving complex data integrity issues related to their bioanalytics laboratory.

Advised numerous drug and device companies related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.

Conducted a significant number of compliance investigations on behalf of drug and device companies, including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling.

Represented Board of Directors of publicly traded pharmaceutical company in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute.

Advised drug and device companies on all aspects of compliance with their corporate integrity agreements.

Advised numerous pharmaceutical companies on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.

Successfully represented a specialty pharmaceutical company in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.

Represented drug and device companies in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.

Advised drug and device companies related to clinical trial regulatory and compliance issues.

Assisted pharmaceutical companies in developing and implementing specialty pharmacy programs.

Represented drug and device companies in connection with adverse FDA inspections, including responding to 483s and warning letters.

Represented drug and device companies in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements.

Led numerous regulatory and compliance due diligence teams in drug, device, tobacco and food transactions.

Represented drug and device companies in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation.

Advised drug, biotechnology, device, food and tobacco companies on legislative matters including drafting and commenting on legislation.

Credentials

District of Columbia

Indiana


Super Lawyers, 2014, 2015 & 2016

Icon close

Close

Recognition


Super Lawyers, 2014, 2015 & 2016