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Compliance programs are relevant to all industries active in the business market. However, they are becoming more critical in specific industries dealing with sensitive assets. These sectors must comply with stricter regulations, not just in terms of manufacturing but also in marketing. The pharmaceutical sector is one such industry.
Pharmaceutical companies must ensure that they have proper pharma compliance and monitoring programs. These regulations are essential to ensure that these programs cater to the legal requirements of each region where the company may operate and maintain continuous updates.
The pharmaceutical industry’s activities directly impact public health, reflecting a stricter law interpretation for the sector. It also leads to increased scrutiny and harsher punitive measures in case of non-compliance.
Why is Pharma Compliance Important?
Regulations in the pharmaceutical sector are continually changing. And it is now up to companies to thoroughly understand how these regulations affect their marketing efforts to promote to the public. Restrictions on promotional materials aim to ensure that consumers receive accurate information that guides them to make good health-related decisions and promote an adequate market.
Pharmaceutical marketers have a legal responsibility to ensure pharma compliance with requirements established by administrative and regulatory bodies. Therefore, their involvement in creating and reviewing compliant marketing materials is vital to avoiding penalties imposed by governing bodies.
Risks of non-compliance in pharma
Given the higher risks associated with the pharmaceutical sector, interactions between pharmaceutical companies, healthcare professionals, and regulatory bodies are not unusual. Government and public administration play a key role in making decisions that affect pharmaceutical companies, and skipping the outcomes of non-compliance becomes inevitable.
Some of the risks of non-compliance in pharma include:
Non-compliance and high fines
Big Pharma cannot just be happy with the rolling profits; they must also safeguard their products from the risk of contamination and damage. The high risk of the pharmaceutical sector should be enough to persuade companies of the need for global and comprehensive pharma compliance programs. These programs must include adherence to both ethical sector and criminal codes. The consequences of not having such a program, or even insufficient details, can result in mandatory extensive compliance standards.
Many pharmaceutical companies have been suffering hefty fines in recent years. However, the repercussions of non-compliance are not limited to basic penalties. In such cases, pharmaceutical companies usually settle by pleading guilty to the accused charges and paying high sums as part of such settlements. The charges typically include medical program fraud, off-brand promotion, and inadequate manufacturing practices.
Damage to reputation
Reputational damage can have a more or less immediate effect and is often far more consequential than the purely financial consequences of a breach. Pharma marketers that handle public relations are also responsible for managing the reputation of a pharma company. The publicity associated with a breach can directly affect the stock market. The company in question for non-compliance may not return to the industry with a damaged reputation.
The reputation of pharmaceutical companies is paramount when dealing with health authorities. Reputation is essential with market access, crisis management in the event of deficiencies or defects, and official correspondence affecting a company’s products. Many factors, like proper pharma waste disposal and adherence to pharma compliance, add to the ethical credibility of a company. An ethical company is likely to get a more reasonable price. In many cases, they enjoy the levy to take less stringent measures than companies with a stained reputation.
Termination of license
Another risk includes the inability to contract or terminate existing licensing agreements. No company wants its reputation exposed by doing business with an unethical company. Therefore, the loss of these contracts can have a significantly higher impact than a fine.
As reported by Dickson data, implementing proper compliance is not a recommendation but a legal and ethical obligation for pharmaceutical companies to directly impact their business. However, compliance is a global phenomenon, and it is essential to note how it is regulated. The consequences of non-compliance can vary significantly from region to region.
Compliance with pharmaceutical products in the United States
Pharmaceutical companies operating in the U.S. are subject to several laws and regulations, and several federal and state governments regulate their conduct. Federal regulators include the Food and Drug Administration, the Office of the Inspector General of the Department of Health and Human Services, the Centers for Medicare and Medicaid Services, the Department of Justice, and the Drug Enforcement Administration (DEA).
In addition, nearly every state has a Medicaid Fraud Unit or state Medicaid Inspector General. These units investigate Medicaid matters, and prosecutors can investigate any suspected violation of state law. Violations of compliance and other laws listed above may subject drug companies to criminal, civil, and administrative penalties, including imprisonment, fines, and exclusion from federal and state healthcare programs such as Medicare and Medicaid. Individual employees can also be held responsible for violations.
Financial penalties can be significant. Consider the FCA’s recoveries totaling more than a billion dollars yearly from pharmaceutical companies and healthcare facilities over the past four years. U.S. regulators expect pharmaceutical companies to design and maintain compliance programs and have issued guidelines outlining these expectations. Pharmaceutical marketers must also follow guidelines for marketing and advertising any pharma product or company.
Increasing industry competition has made pharmaceutical companies appreciate the work that marketing and sales professionals add to their bottom line. Marketing budgets exceed R&D budgets, ensuring their products target the appropriate audience. In addition, pharma marketers rely on sophisticated compliance technology with high financial stakes and little room for legal error. It helps their teams identify and mitigate risks while creating content. As a pharma marketer, you have all the opportunities to make the best of the space. First, however, you must be careful and aware as you strategize every step of your next campaign.
