Four Disclosure Compliance Risks that Clinical Trial Sponsors Should Identify and How to Avoid Them

Trial disclosure regulations around the world continue to evolve, are not well harmonized across jurisdictions and can be fairly complex.  There are over 40 countries or regions with mandatory trial disclosure regulations and over 30 trial registries for posting clinical data.  While trial sponsors have developed policies, processes and systems to address key trial disclosure requirements, few have evolved systems for continuous monitoring of trial disclosure and registry requirements, or have the systems to monitor and harmonized disclosure of trial information globally. Four practices in particular rise to the surface as major risks for trial sponsors regarding current and ongoing compliance. [Read more…]

Defending Against Third-Party Patient Record Data Breaches: What Compliance Officers Need to Know

These days it seems as if large corporations, government agencies, insurance and life sciences companies experience breaches on a disturbingly frequent basis. Not only do these information thefts result in direct losses by the breached entity as a result of fines and damages, their reputations and consumer confidence levels can take a serious hit. A study from the Ponemon Institute found that data breaches cost the healthcare industry $6 billion a year. Additionally, about half of healthcare organizations surveyed by Ponemon said they didn’t have sufficient technology to prevent or quickly detect a breach, or the personnel with the necessary technical expertise.
[Read more…]

Four Risks Pharma Companies Face

The pharmaceutical industry, like many others, has faced increased legal challenges and regulatory oversight as it has expanded into emerging markets and it has confronted additional risks associated with technological advances. In recent years, pharmaceutical companies have paid hundreds of millions of dollars to resolve Department of Justice (“DOJ”) investigations, seen employees charged in criminal cases around the world and have been besieged by faceless aggressors seeking proprietary information.  Here, we detail four of the biggest risks facing pharmaceutical companies today: cybersecurity, global corruption, fraudulent marketing, and government scrutiny of potentially anticompetitive conduct that could violate antitrust laws.
[Read more…]

Increased Globalization and Supply Chain Complexity Poses Serious Risks to Pharma Safety

More than ever before, increased globalization and supply chain complexity pose a serious risk to patient safety. According to Deloitte, the global pharmaceutical market was expected to generate all-time-high total revenues of $1.23 trillion in 2014. The U.S. imports nearly 40 percent of the country’s finished drugs, and nearly 80 percent of our active pharmaceutical ingredients (API) come from overseas sources. With a market this large and complex, and regulatory bodies around the world pushing to implement new and sometimes conflicting requirements, it’s no wonder that regulatory compliance is the top business and supply chain issue among healthcare executives in the latest UPS Pain in the Chain survey. By better understanding key pharmaceutical supply chain risks, regulations and best practices, executives can more effectively implement a safe and secure supply chain.

Top supply chain security risks

Unfortunately, there are many points at which products can be contaminated during the journey from raw source materials all the way to finished products for consumers. The following summarize the four primary risks executives should be aware of and work to mitigate:

  • Intentional adulteration is the purposeful contamination of a product in the manufacturing, storage or distribution process, or from ingredient substitution. A similar risk, Economically Motivated Adulteration, is focused on adulteration for economic gain, which can include other motives such as terrorism and disgruntled employees. In June, the FDA announced its global strategic framework to combat SSFFC (Substandard, Spurious, Falsely-Labeled, Falsified, Counterfeit) products with a specific focus on good manufacturing, distribution, and pharmacy practices, and the convergence of global standards to create a more level playing field for the legitimate supply chain to combat adulteration.
  • Cargo theft is the criminal taking of any cargo that constitutes a commercial shipment of freight moving in commerce. In 2014, $89.5 million of cargo theft was reported in the U.S. alone, according to CargoNet. Inbound Logistics reported that in the U.S., the most highly sought after shipments are pharmaceuticals, consumer electronics, apparel and food.
  • Counterfeiting is fraudulently mislabeling a product in identity or source. Operation Pangea VIII, the latest annual operation coordinated by INTERPOL to combat the online sale of counterfeit and illicit medicines seized a record 20.7 million fake and illicit medicines from 115 countries, valued at $81 million.
  • Diversion of products from the intended authorized market to another also poses a significant risk to supply chain security. Today, companies are looking to technological advances to help prevent against drug diversion.

Global supply chain security regulations
Several high profile incidents such as the heparin adulteration and the counterfeit Avastin cases, have spurred governments and regulatory bodies around the world to implement legislation and policies to tighten supply chain security. In the U.S., the Food and Drug Administration Safety and Innovation Act (FDASIA) and Drug Supply Chain Security Act (DSCSA) were put in place to address risks throughout the pharmaceutical supply chain.

FDASIA granted the FDA new authorities to address upstream risks including, refusing entry of an imported drug if the manufacturing facility inspection is denied or limited; enhanced penalties for suppliers of counterfeit or substandard products; and requiring a unique manufacturing facility identifier for both domestic and foreign facilities.

DSCSA, also known as Title II of the Drug Quality and Security Act (DQSA), was established in 2013 to address downstream risks and will facilitate the exchange of information about where a drug has been in the supply chain. This aims to enable drug legitimacy verification, enhance detection of illegitimate products and facilitate more efficient recalls. The law requires the FDA to develop standards, guidance and programs to support efficient and effective implementation over a 10-year period.

Similarly in the EU, the Falsified Medicines Directive seeks to address supply chain security through a focus on validating that all manufacturers and distributors of APIs comply with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) standards and verifying the authenticity of medicinal products.

In China, the Chinese State Food and Drug Administration (CFDA) introduced revised GMP regulations in 2010 modeled after U.S. and Europe and made serialization mandatory for over 275 therapeutic classes of individual units by December 2015.

Best practices for supply chain security
Proactive pharmaceutical supply chain security starts with building an end-to-end security program. The following best practices promote enhanced and streamlined security of organizations, while working to mitigate supply chain risks and comply with global regulations.

    >Global program management: Ensuring compliance to corporate standards and differing local country regulations requires centralized management of supply chain security standards across the enterprise. Increased standardization enables the consistent implementation of programs and processes necessary for effective risk mitigation across the globe.
  • Enterprise-wide systems integration: For effective and consistent response to supply chain threats, it’s critical to integrate security and IT systems to meet specific business objectives. Pull a cross-functional team together to assess and identify key areas of vulnerability, then develop an integration roadmap that can take advantage of today’s IP-based technology such as a Physical Security Information Management solution that automatically links video, access control and equipment sensors to provide real-time alerts and prioritizes and automates the response workflow to help minimize the risk of manual oversight.
  • Continuous compliance verification: Regulatory bodies around the world are focusing on compliance to GMP and GDP standards as a key measure of supply chain security. Cloud-based services like remote video audits allow the monitoring of any facility and any process around the world to ensure compliance. Random remote video audits at various shifts, at multiple facilities, provide a much higher degree of compliance validation than the infrequent physical audits.

What it all means
The pharmaceutical supply chain will continue to face new obstacles as the industry develops and regulations evolve. To be successful, executives must fully understand the current key risks, regulations and best practices in order to set standards and implement technologies that properly and proactively secure their organization’s supply chain.

Risks and Production Issues Pharmaceutical Manufacturers Face

The manufacturing of pharmaceuticals is an industry that has attracted many new global companies. There are many business risks associated with this highly regulated industry that need to be considered. Given our vantage point in providing audit and due diligence services to the middle market pharmaceutical industry, we will comment and provide observations on a few recurring risks that we have seen on a repeated basis: The dependency on suppliers, doing business abroad, creativity in deal structuring, and the value of integrated systems.
[Read more…]

Optimizing the Customer Experience Leads to Improved Bottom Line and Clearer Compliance

Customer centricity is what we have come to expect from all of our commercial relationships. Whether the bar has been set by Zappos or Amazon, the notion of a flawless customer experience has penetrated the corporate psyche. Customers are no longer willing to choose between product quality, speed of delivery, and price. Simply put, they want it all.
[Read more…]