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Recent Developments and Takeaways from this Year’s Pharma Compliance Congress

The Pharmaceutical Compliance Congress is a leading industry event that categorizes recommended best practices for pharma companies to follow that ensure compliance with regulatory requirements. It’s crucial to these companies, since they already make such large investments building out their compliance divisions.

Compliance programs represent a significant expense for pharmaceutical companies because they must be sophisticated enough to collect safety data, audit supply chain procedures, and supervise storage facilities. These require substantial investment, but failure to meet compliance standards leaves pharmaceutical companies vulnerable to future legal liability. Consequently, large companies are constantly on the lookout for tools, procedures, and strategies to accomplish pharma compliance goals.

The Pharmaceutical Compliance Congress was formed to provide solutions that meet the demand for these new approaches to compliance. The conference helps pharma companies overcome regulatory scrutiny and mitigate risk by offering all-inclusive compliance and ethics programs. It features a host of industry-leading compliance experts from a variety of different companies, including Cynthia Cetani, a Chief Integrity and Compliance Officer, Jim Stansel, an executive vice president and general counsel, and Jake Deboever, a Chief Compliance Officer.

The C-suite executives, along with many others, shared valuable insights on how decision makers can improve the integrity and decrease the costs of pharma compliance divisions. Here are some of the most actionable takeaways from the conference.

State Pricing Disclosures and Social Media Use

One of the most important priorities for compliance departments to keep track of is the drug price transparency requirements of states they do business in. Each state in the US has different regulations concerning how drug companies disclose the price they sell medications for. Despite aggressive pharmaceutical lobbying, 18 states require that companies provide notice to local government officials before raising drug prices above a certain threshold. John Oroho, a speaker at the conference and an Executive Vice President and Chief Strategy Officer, noted that seven-figure penalties had been issued to companies for failure to report on time.

This is especially relevant for companies with plans who plan to launch or promote a new high-cost drug. Pharma companies selling expensive drugs might have high prices to pay if they don’t make sure their compliance divisions do their due diligence.

Another topic discussed at the conference related to the use of social media advertising for pharmaceutical products. Marketing and advertising have changed dramatically since the rise of the internet, as brands can now create ad messaging that tailors to groups of consumers meeting very specific demographic criteria. Social media has also given rise to influencer marketing, where brands partner with online personalities to promote their products.

These new marketing strategies are difficult for pharmaceutical companies to engage in, given the restrictions of drug marketing both within the US and abroad. Drug advertising is prohibited in most countries outside of the US, so, given the global reach of the internet, this can represent a compliance challenge. Nonetheless, many pharmaceutical companies use influencers to promote their products. But these firms must be careful not to run afoul of both domestic and international regulations pertaining to drug advertising. It’s a critical part of pharma compliance. The importance of this can be seen in the cautionary tale of Khloe Kardashian and Biohaven Pharmaceuticals being called out for their promotion of off-label drug claims.

According to Dickson, compliance departments must do extensive research into exactly how they can leverage influencer marketing without violating international regulations. One basic approach is to confine ads to specific geographical areas through social media advertising dashboards.

Role Drift and Technology Concerns

Also discussed at the conference was the problem of role drift within compliance departments. The term role drift refers to the problem of compliance workers not having clearly defined responsibilities within an organization. In these scenarios, ambitious workers might start taking on too many responsibilities while others underperform. This creates a productivity discrepancy that can undermine compliance and decrease morale in the workplace.

A good solution to this problem is to offer specific job descriptions paired with a business plan that reflect that role to clarify expectations. Training can then be modeled to those specific expectations and roles. There should also be clear handoffs between different operational functions in the organization.

When companies address role drift, they should also optimize the often overlooked issues of data integrity and privacy as part of an effective compliance strategy. For example, pharmaceutical companies use a variety of technological tools like data loggers to collect and record environmental data that then must be formatted and submitted to regulators. Many pharma companies that use artificial intelligence or machine learning algorithms to draw conclusions from this data should consider whether their AI use is in line with regulations.

Clinical Trials, Telehealth, and COVID-19

Many pharmaceutical companies run their own clinical trials to scientifically validate the efficacy of their products. This often creates a conflict of interest in which companies are incentivized to conclude that their products are beneficial. However, clinical trial fraud is punished extremely severely. Compliance departments should ensure that all clinical trails are run ethically and interpreted fairly.

Lastly, another topic of discussion at the conference concerned the increasing use of telehealth services. The rise of telehealth comes on the heels of the COVID-19 pandemic response, which limited many people’s access to healthcare providers. There will be an expansion of COVID-related services which means that compliance compartments need to carefully oversee allocated funds, vaccinations, and grants to make sure that they are not misused. They should also make sure that, when they engage in telehealth, all typical doctor-patient ethical guidelines are followed.

The Pharma Compliance Congress offered many valuable insights that pharmaceutical companies should keep in mind moving forward. This event as well as future summits will be important resources to help pharmaceutical companies make important, necessary ethical decisions.

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