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Pharmaceutical Regulation for Patient Protection

With increased regulation, pharmaceutical companies are turning away from sales representatives to promote their products and instead looking toward medical affairs professionals to provide quality information to ensure patient safety.

We spoke with Dr. Sushil Panda, M.D., the Regional Scientific Expert – Retina (APAC) for Allergan in Singapore, to learn more about how medical affairs is now becoming the trusted voice for the industry.

He began by explaining that it’s a common misconception that medical affairs professionals are just amped-up (or super) pharmaceutical sales representatives. “Medical affairs professionals are not the super heroes of pharmaceutical sales. They do not have a sales target – and their salaries are not dependent on the commercial success of a product,” said Dr. Panda. 

“Salespeople have one job: to sell. That is not the goal of medical affairs. We do not say, ‘this drug is the best,’ instead we are focused on what is best for the patient,” he continued.

In order for medical affairs professionals to be a trusted source of information, they must be unbiased. If the pharmaceutical company they work for has a medication that is shown to have unfavorable results, it is their job to communicate that information. Medical affairs professionals communicate with three main entities: external healthcare providers (doctors), internal stakeholders and healthcare organizations (governmental bodies). 

Those who focus on external affairs, will work to ensure that doctors get the right information to prescribe the correct medicines and dosages.

“Of course, doctors know many things. However, they may not be up-to-date on all the possible medicines or treatments available – this is where medical affairs can step in to provide responsible advice that has the best interest of the patient in mind,” added Dr. Panda. “Again, they are not there to sell to the doctor, but to provide accurate information based on facts, safety and efficacy.”

Medical affairs professionals also relate critical information to internal stakeholders. 

“With internal stakeholders, we have to play a strategic role. This requires planning and scientific evidence, and must be done within a standard operating procedure to be compliant,” he explained. “For example, if a new drug is being released, we will ensure that the correct dosage is promoted, as well as the correct intended use. That distinction must be made based on scientific evidence.”

Medical affairs personnel also work closely with healthcare providing organizations or regulating governmental bodies. They provide research and evidence to give a fair and balanced opinion, without any commercial intent.

“Someone who reports to a healthcare organization might help answer questions like: ‘what diseases are most prevalent?’ or ‘what are right guidelines for this medicine?’” said Dr. Panda. 

Working with so many different teams within an organization requires collaboration on all sides. “It’s important for medical affairs professionals to work well with others, and to be firm: a yes is a yes, and a no is a no,” he added. 

And like everything concerning the healthcare industry, this is an evolving field as well. “This isn’t the way it used to be… there are more checkpoints, and we’re getting better results. That is the benefit of an unbiased view.” 

Much of this regulation has come into effect because of drug misuse, incomplete testing, or a focus on sales figures over patient safety. Those in the healthcare industry may be familiar with the Sulfanilamide Disaster, which was responsible for more than 100 deaths in 1937. Before this tragedy the drug had been used in the tablet and powder form without any ill-effect. Then, a salesman reported that there was a need to have the drug in liquid form. The company’s chemist created it… and tested it for flavor, fragrance and appearance. But, what they didn’t test it for was toxicity – because at that time, they didn’t have to. While selling toxic drugs could damage a company’s reputation, it wasn’t illegal. Thankfully, we’ve come a long way… but there is still more that can be done.

“Following this disaster, among others, clinical trials are now mandated from Phase I to Phase IV,” said Dr. Panda. “There’s always a right way to do things. What we want to do is a good thing, in the right way… and that’s by being responsible and providing unbiased scientific evidence to ensure the safety of patients and the efficacy of the medicine.”

Dr Sushil Panda

Dr. Sushil Panda, MBBS, M.D.

Dr. Sushil Panda, MBBS, M.D., brings along with him over 16 years of comprehensive experience in clinical, medical teaching and pharma-medical affairs. He has past experience as a clinician in the Department of Surgery of Tata Hospital, India, and subsequently worked as an assistant professor in the Department of Pharmacology, J N Medical College, India. Before joining Allergan, Dr. Panda worked at Bayer as medical advisor for ophthalmology and oncology. He later joined Allergan as India lead for retina therapy of the company’s eye care portfolio. Currently he is based at the regional office of Allergan in Singapore and works as its Regional Scientific Expert-Retina-(APAC), Medical and Scientific Affairs, Eye Care.

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