News & Analysis as of

Penalties Pharmaceutical Industry

A&O Shearman

EU publishes summary of recent competition enforcement in the pharmaceutical sector and promises to continue policy of proactive...

A&O Shearman on

The European Commission (EC) has published its latest report on competition enforcement in medicines and medical products. Key takeaways are that: EU and Member State authorities imposed multiple material antitrust...more

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

Cornerstone Research on

The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

Arnall Golden Gregory LLP

Life Sciences Investigations – 2020 Year in Review and 2021 Outlook

On February 11, 2020, AGG’s Government Investigations practice chairs, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021...more

Thomas Fox - Compliance Evangelist

Top Five Department of Justice FCPA Enforcement Actions in 2019

Welcome to the 2020’s. The past decade helped shape both Foreign Corrupt Practices Act (FCPA) enforcement and corporate compliance programs. 2019 FCPA enforcements bore out many of the developments from the preceding years of...more

Dechert LLP

Chicago Proposes Pharma Rep Licensing Rules and Ethical Standards

Dechert LLP on

The City of Chicago Commissioner of Public Health on Friday, March 17, published proposed Rules to implement the highly-publicized pharmaceutical representative licensing ordinance enacted in November 2016....more

Stinson - Corporate & Securities Law Blog

SEC Brings Enforcement Action for Disclosure Failures During Merger Talks

The SEC announced that Allergan Inc. had agreed to admit securities law violations and pay a $15 million penalty for disclosure failures in the wake of a hostile takeover bid. The SEC’s order finds that Allergan failed...more

The Volkov Law Group

Badda Bing, Badda Boom!! — DOJ and SEC Make 2016 a Record Year for FCPA Enforcement (Part I of III)

The Volkov Law Group on

We begin the New Year with a three-part series on the FCPA: (1) A review of FCPA enforcement in 2016; (2) Trends from 2016 FCPA enforcement; and (3) Predictions for FCPA enforcement in 2017....more

The Volkov Law Group

Aggressive Remediation: Embraer and JP Morgan

The Volkov Law Group on

There is no question that the Justice Department has raised compliance program expectations in a number of areas. Whatever you may think about the efficacy or fairness of the FCPA Pilot Program, the Justice Department has...more

King & Spalding

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

King & Spalding on

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

Manatt, Phelps & Phillips, LLP

Will NYSDEC's Audit Agreement for Retail Pharmacies Provide a Path to Increased Compliance?

Federal and state hazardous waste handling and disposal requirements, which were established to address issues related to industrial waste generators and disposal facilities, are often a complicated and awkward fit for retail...more

Foley & Lardner LLP

Hospitals Urging SCOTUS to Limit False Claims Act Penalties

Foley & Lardner LLP on

What do a moving company and a hospital association have in common? The False Claims Act (FCA). The American Hospital Association along with the United States Chamber of Commerce and the Pharmaceutical Research and...more

Holland & Knight LLP

FTC Announces Amendments to Hart-Scott-Rodino Rules Regarding Pharmaceutical Patent Licenses

Holland & Knight LLP on

The Federal Trade Commission (FTC) has announced revisions to the rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) that will apply to certain transactions involving the transfer of patent rights in...more

Manatt, Phelps & Phillips, LLP

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

Dechert LLP

Pending Bill Would Expand FTC Powers Over Drug Patent Settlements and Alter the Legal Test

Dechert LLP on

Key Points: - This month several U.S. Senators introduced the Preserve Access to Affordable Generics Act. There is no similar bill pending in the U.S. House. - The Act revives legislative efforts to wipe out the...more

Perkins Coie

CMS Issues Final Physician Payment Sunshine Act Regulations

Perkins Coie on

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more

Holland & Knight LLP

CMS Issues Final Physician Payment Sunshine Rule

Holland & Knight LLP on

In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

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