June 12, 2019

FOR IMMEDIATE RELEASE
June 12, 2019
CONTACT: Erinee Endrawis
PHONE: (908)704-7323
E-MAIL: eendrawis@gmhllc.com


G & M HEALTH, LLC and BMI SYSTEMS, S.A.S. Forge Strategic Collaboration to Develop Ground-Breaking Global Transparency Solution for the Life Sciences Industry
New Global Transparency Solution from Respected Industry Veterans Will Provide Comprehensive Coverage for Increasingly Complex U.S. and Global Transparency Requirements

BRIDGEWATER, NJ – G&M HEALTH, LLC (USA) and BMI SYSTEM, S.A.S. (France) today are proud to announce the signing of a collaboration agreement for the development of a comprehensive global transparency and compliance solution for the life sciences industry. In response to the growing demand from the life sciences industry to manage their governmental global transparency and compliance obligations, this solution will provide life sciences industry customers a ground-breaking “one-stop shop” for transparency reporting and compliance.

Over the past fifteen years, the standards and laws governing manufacturers' relations with health professionals, health organizations and patient associations became increasingly complex and burdensome, particularly in regards to interactions with health-care providers and disclosure to governmental and regulatory agencies. As the growing trend in compliance is towards harmonisation, internationally deployed life science companies must respond at the global level to evolving compliance requirements.

“We are excited to bring this new and innovative offering to our 100+ life sciences customers. This global transparency solution offers a single dashboard to manage all global requirements.” said Robert Melillo, Managing Director at G&M HEALTH. “Working with another industry leader will enable us to provide our customers an unbeatable experience.” He concluded: “Our clients deserve state-of-the-art technology and we intend to keep on delivering innovation.”

"Since its creation, BMI SYSTEM's teams have been committed to adapting our solutions to the expectations of our customers while integrating regulatory developments in the more than 50 countries where NAYACT® is deployed," said Jérôme Martinez, President of BMI SYSTEM. He continued: "By coupling our NAYACT® GS platform with G&M HEALTH's U.S. robust pharmaceutical compliance and transparency solutions, we now have a complete solution to manage all transparency and compliance activities on a global basis. “

G&M HEALTH, LLC is a U.S. based healthcare and life-sciences service company offering commercial compliance consulting, aggregate spend solutions, computer validation, project management, audits & assessments, training and regulatory support services. G&M was founded by recognized legal and regulatory compliance experts in the healthcare industry, who have worked with and/or advise hundreds of pharmaceutical and biotech companies over the last 10 years. G & M’s multi-faceted software solutions include:
1. Aggregate Spend/Transparency Reporting
2. SHERLO® for auditing and monitoring
3. Pharma Classes ® for interactive compliance training
4. StatCheck ®for Significant Loss Threshold determination; and
5. SHALL ® State and Federal Law library

Learn more at: www.gmhllc.com

BMI SYSTEM is the leading French software company for the management of pharmaceutical transparency and compliance. It’s products NAYACT® and ORYGA® provide for the governance of personal data and compliance with the European General Data Protection Regulation (GDPR). It’s NAYACT® platform, which has been deployed in more than 50 countries (Europe, Latin America and Asia), provides BMI SYSTEM customers with contract management, HCP engagement tracking, and reporting to relevant bodies utilizing proven functionalities including: Privacy by design, Management of cross-border flows of information, compliance with local regulations, reporting and dashboard (BI) organized by country and consolidated areas.

Learn more at: www.bmi-systems.com
March 2018

DOJ Enforcement Priorities: Targeting Companies that Threaten Patient Health & Safety

On February 28, 2018, Deputy Assistant Attorney General Ethan P. Davis (DAG Davis) provided remarks to the FDAnews conference on off-label promotion. DAG Davis leads the Justice Department Civil Division’s Consumer Protection Branch, which is responsible for “enforc[ing] statutes designed to protect the health, safety, and economic security of American consumers.” This includes enforcing, both civilly and criminally, the Federal Food, Drug, and Cosmetic Act. Although the conference was related to off-label promotion, DAG Davis provided an overview of DOJ’s enforcement priorities when targeting pharmaceutical and medical device companies.
Setting the Stage
DAG Davis “set the stage” by first commenting how “[t]he Department does not approach its enforcement responsibilities with a belief that the pharmaceutical industry is full of bad actors.” He then explained that off-label uses and treatments “may be important therapeutic choices” and how physicians have a right to prescribe drugs for off-label uses. He followed by discussing how the DOJ decides where to focus its enforcement resources and certain questions that the Department considers. Specifically, the DOJ “identif[ies] practices that threaten patient health or safety.”
Targeting Certain Off-Label Promotion
According to DAG Davis, DOJ determines whether to take action against companies that promote off-label begins by asking certain questions: “Was the speech at issue false or misleading, or was it truthful? Did the off-label use injure patients, or did it help patients?” DAG DAVIS then reiterated the government’s long-standing position that it “will vigorously investigate and prosecute firms that make false or misleading statements to prescribers or patients.” He provided several examples of recent enforcement actions targeting off-label promotion (read the DOJ press releases here, here, and here) that were symbolic of companies engaging in practices that could potentially pose a threat to patient health or safety.
DOJ’s Commitment to the Rule of Law
DAG Davis elaborated on patient health and safety by stating, “[t]he Consumer Protection Branch’s approach to investigating and prosecuting cases that threaten the health or safety of patients reflects the Administration’s broader emphasis on the rule of law.” He explained how the DOJ has “taken certain steps to promote and protect the rule of law,” such as the DOJ’s November 2017 announcement that it “would no longer issue guidance documents that effectively impose new regulatory requirements or obligations on private parties” and the January 2018 internal memo discussing how the “civil litigating components may not use their enforcement authority to effectively convert agency guidance documents into binding rules.” He explained how these actions were done to ensure that the rule of law remains consistent and predictable.
Enforcement Priorities
DAG Davis returned to how the DOJ will target companies that engage in practices that may have “serious public health implications.” He placed emphasis on two issues: (1) the opioid crisis; and (2) insanitary conditions and noncompliance with current Good Manufacturing Practices (cGMPs). In regards to the opioid crisis, he noted the recently formed Prescription Interdiction and Litigation Task Force and how DOJ will enforce compliance with FDA’s REMS requirements for opioids. On cGMP compliance, he referenced several examples (read the DOJ press releases here, here, and here) and how the DOJ will focus on “whether noncompliance poses a risk of patient harm.”
Takeaway
Based on the remarks from DAG Davis, companies should not view it as a prescription to engage in truthful and nonmisleading off-label promotion. Thus, companies should continue to comply with FDA’s laws, regulations, and guidances. In terms of DOJ’s enforcement priorities, companies should analyze business practices, such as product promotion and cGMP compliance, by asking whether current practices could cause patient harm. This may not be an easy question to answer, but the case examples that DAG Davis cited may certainly help understand the type of conduct that could lead to enforcement action.
August 2017

Are your company’s press releases a ticking time bomb?

As a compliance officer, it is important to review how communications are reviewed and approved before being made public. Having improper controls or no controls at all can lead to U.S. Food and Drug Administration (FDA) enforcement action, jeopardize the company’s chances of FDA approval of an investigational drug, and if the company is publicly listed on the U.S. stock market, the Securities and Exchange has the authority to charge the company and even its employees for making misleading statements, among other charges. Before you say, “We’re fine,” see the case examples below.

FDA Untitled Letter: In 2012, FDA’s Office of Prescription Drug Promotion (OPDP) issued a letter against a company regarding the firm’s websites, including posted press releases and videos, promoting the company’s investigational products. Promotion of an investigational new drug is prohibited under FDA regulations at 21 CFR 312.7(a). However, this section does not “restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media.”

Thus, OPDP found the totality of claims made throughout the websites, press releases, and videos suggested the product was safe and/or effective. OPDP further added, “[t]hese claims are concerning from a public health perspective because they make promotional claims about the safety and efficacy of investigational new drugs that have not been approved by the FDA.”

FDA Untitled Letter: In 2016, FDA’s OPDP issued a letter to two pharmaceutical manufacturers regarding websites promoting the company’s investigation drug, then under FDA review, as safe and effective. The websites for the product failed to clearly convey it was an investigational new drug, not authorized for marketing in the United States for any indication. OPDP stated the following:

Conclusory statements regarding safety and effectiveness of a drug, made while an application for the product is under review, suggest an effort to shape public impressions of the drug in the lead-up to its launch, before FDA’s evaluation of the product is complete and reflected in approved drug labeling. Such statements raise considerable public health concerns and may remain probative evidence later when a product is in broad distribution. The statements are particularly irresponsible and alarming with respect to an opioid drug product. [emphasis added]

Like the previous case example, companies can freely exchange scientific information and findings in scientific or lay media. Companies cannot “represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.” See 21 CFR 312.7. Shortly after receiving the Untitled Letter, FDA issued its denial of the manufacturers’ new drug application.

SEC Action: In 2016, the SEC charged a pharmaceutical manufacturer, including the company’s chief executive officer, chief financial officer, chief medical officer, for making misleading claims in a press release, as well as other corporate disclosures and statements, related to the company’s investigation product. As part of the government’s complaint, the SEC alleged that one press release was misleading because it failed to disclose the FDA’s recommendations to conduct a second trial. A Form 10-Q was also filed that contained the CEO’s certification that “it did not contain any untrue statement of material fact or omit to state a material fact necessary to make the statements therein not materially misleading.” The SEC alleged the CEO’s certification was also misleading because it failed to disclosure FDA’s recommendation.

The company and its officers were charged with violations of the antifraud provisions of the federal securities laws and various. The company agreed to pay a $4 million penalty to settle the SEC’s charges without admitting or denying the allegations in the complaint. The case continued against the corporate officers, as the SEC seeks disgorgement plus interest and penalties, permanent injunctions, and officer-and-director bars against them.

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April 2017

On April 24th at the Ethics and Compliance Initiative Annual Conference, Attorney General Jeff Sessions made clear that the Department of Justice (DOJ) remains committed to enforcing the nation’s fraud and abuse laws. While health care fraud will continue to be investigated, special emphasis was placed on the Foreign Corrupt Practices Act (FCPA).

Under the FCPA, it is unlawful for certain classes of persons and entities to make payments to foreign government officials to assist in obtaining or retaining business. This anti-bribery statute applies to all U.S. persons, as well as certain foreign firms and persons; additional accounting provisions apply to publicly traded companies listed in the United States. Attorney General Sessions said it was “critical” to enforce the FCPA in order to “protect honest businesses.”

The Attorney General also discussed the importance of holding individuals accountable for corporate misconduct and bringing these individuals to justice. In addition, he stressed how when making charging decisions, the DOJ will continue to take into account a company’s “good” compliance program, their cooperation, self-disclosure, and acceptance of responsibility for their misconduct

Similar remarks were made a week ago by Acting Principal Deputy Assistant Attorney General, Trevor McFadden, at the Anti-Corruption, Export Controls & Sanctions 10th Compliance Summit, who added that the DOJ was “making a concerted effort to move corporate investigations expeditiously.” Their statements, including the February 8th publication of the “Evaluation of Corporate Compliance Programs” on the DOJ Fraud Section’s website, are strong reminders for companies to ensure they have an effective compliance program.

If you’re looking to assess your compliance program or need a hand in carrying yours out effectively, G&M Health has you covered!