Pharmaceutical Sales: Balancing Profit, Patient Care, and Integrity
Pharmaceutical sales teams are now required to “know” and “follow” ECCP’s highly regulated requirements to ensure compliance and integrity. The DOJ’s Criminal Division released an update to the use of personal devices, communication platforms, and messaging platforms. All companies are required to have policies and procedures to ensure employees are not using unapproved platforms for business communication. The second substantial revision to ECCP expands on how compensation structures drive compliance and implemented substantial penalties for non-compliant behavior.
Lessons from the Past
Little did the producers of the 1997 sitcom Ally McBeal dream of how the “miniskirt” would influence pharmaceutical corporate America. Fast forward to 2024 a new pharmaceutical team heard two former MSLs boasting their success stories much of which was attributed to “miniskirts” early in their careers. A global New Jersey-based pharmaceutical company released 5 sales reps who submitted receipts for reimbursement for a “meeting” held at a local strip club. Cruises for high prescribing physicians, spouses, and the sales reps were an annual event for many major pharma companies. Discrimination for sales rep job applicants were ablaze. In 1992 I personally applied for a sales rep position with my then major pharma employer. “You’re not thin enough to be a sales rep.” Mind you, I had just delivered a set of full-term twins whose combined weight was 15 pounds. While I wasn’t back in my miniskirt body, I continued by journey in clinical operations and compliance.
Sales Reps Need to Know
Pharmaceutical sales teams need to know there are dozens of laws regulating the industry. Government agencies including but not limited to US Department of Justice (DOJ) Evaluation of Corporate Programs (ECCP), Office of Inspector General (OIG), Federal Communications Commission (FCC) Telephone Consumer Protection (TCPA), Federal Trade Commission’s (FTC) CAN-SPAM Act, Health Insurance Portability and Accountability Act of 1996 (HIPAA), and the Foreign Corrupt Practices Act (FCPA). All of these agencies serve to protect patient safety and public health. Pharmaceutical companies are required to abide by endless laws: Food and Drug Administration (FDA), Department of Justice (DOJ), Foreign Corrupt Practices Act (FCPA), Health Insurance Portability and Accountability Act (HIPAA), and The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
In today’s fast-paced and driven pharmaceutical industry sales reps are most often well-educated medical professionals with the credentials to support their position such as Pharm.D., Ph.D., MSN, or MSc. Pharmaceutical sales reps are tasked with promoting the company’s FDA approved product to healthcare professionals. There is a delicate balance between the protection of public health, avoiding legal consequences, and corporate profitability. FDA requires companies to report adverse reactions within 7 to fifteen days of being aware.
Sales reps are on the forefront of healthcare professional interactions may be the first person to receive an adverse report. Patient safety is always first and foremost. Substantial legal penalties and litigation are often the outcome of failure to report adverse event data. “In January 2024 Johnson & Johnson agreed to a $700 million settlement with 42 states and the District of Columbia regarding its talc-based products.” (Top Class Action Lawsuits, January 23, 2024)
Simple Success as a Sales Rep
Sales reps should have an in-depth knowledge of their product as documented in the package insert. Know the clinical trials which supported the FDA approval. Be well versed in the known side effects of a product and be alert to healthcare professional reports of unknown side effects which need to be reported. Develop strong relationships with healthcare professionals. Demonstrate value-added services such as Patient Assistance Programs or charitable programs. Use excellent communication and people skills to develop a positive rapport with healthcare providers.
Negotiation Skills
Sales reps should develop good negotiation skills. This applies to successful formulary placement, cost negotiations, and healthcare provider face-to-face product discussions. Know the therapeutic indication in detail and what new treatments are available to patients. Maintain an ongoing clinical development program to ensure awareness of the rapidly changing healthcare environment. This will allow for open and educated discussions with healthcare professionals.
Pharmaceutical sales ethics is an evolving industry. Recent DOJ ECCP updates require ethical oversight and business conduct. Highly trained medical sales reps are a pharmaceutical company’s ambassador AFTER a drug/device is FDA approved. Building trust, honesty, and a patient-centric corporate environment is required. Ethical pharmaceutical sales reps can provide valuable insights and contribute to discussions about patient care. This ultimately benefits the healthcare system as a whole.
Gail Trauco, RN, BSN
The PharmaKon LLC specializes in clinical pharmaceutical product development, clinical trials, and mobile nursing. It is a 100% woman-owned business led by its CEO/founder Gail Trauco, R.N., BSN. The PharmaKon has a unique understanding and connection to rural healthcare and underserved communities by way of Trauco’s personal experiences growing up on a family farm in her native North Carolina. Despite challenges with generational grief and poverty, Trauco persevered through high school and college at University of North Carolina at Chapel Hill and then began a life and career of her own as an oncology nurse.
An Oncology nurse, pharmaceutical trials expert, and long-time Patient advocate, Trauco has spent four decades helping patients navigate the sea of red tape in the American healthcare system. Based just outside Atlanta, she has gained a reputation as a fierce advocate for patient’s rights and for resolving some of the most difficult medical cases in the currently crippled healthcare industry. As a lifelong healthcare professional and frequent on camera expert, Gail Trauco is equal parts Gloria Allred, Erin Brokovich, and Nancy Grace…with a small twist of Dog the Bounty Hunter.
