Wednesday, March 25, 2009

Bowing To The Will Of Others: Pharmaceutical Compliance

In the past, a typical compliance element of a medical corporation was often viewed by those within this corporation as a necessary, yet ostracized entity. Its purpose was viewed as keeping others within the corporation out of legal issues.

The compliance program has historically been determined and defined by the corporation’s board of directors. These directors who have a financial stake in the pharmaceutical corporation are therefore biased with their involvement of the company’s compliance program.

The corporation’s marketing department historically and often has referred to the compliance program of their corporation as the ‘sales prevention department.’

The situation is a bit different now with the pharmaceutical industry.

A drug company should be committed to their compliance needs to ensure stability of their company. The compliance should be intact as far as current knowledge about the reguations and statutes that regulate it's industry. This includes such recommendations as not only the benefits of documentation, but also how to document appropriately to avoid legal intervention. This has happened in the past when the wrong words are written on internal documents.

Such documents containing what may be very powerful words should be avoided from being composed. Internal annotations of any type with such words can be a catalyst for an investigation of your organization for suspected wrongdoing. Intent is not relevant, nor is ignorance.

As a business in your industry, you need to be aware of the challenges you may face unexpectedly so you can maintain your favorable image.

In addition, your entire workforce needs to be informed of various regulations and statutes that exist, or have been altered. This happens often with the laws that govern your industry. Lately, the alterations to those who watch over you have not been in your favor..

Nuanced instruction and training is needed to have what is necessary to ensure compliance is known and implemented within your company. This means that the leadership of the compliance department must be convinced that all members of the organization are in agreement with what should and should not be done.

Additionally, there are paradigms that others can offer outside of your organization may improve the overall efficacy of your existing compliance program. Consider acquiring their services and instruction.

So a third party may offer additional insight into your own compliance program. Many drug companies today remain vulnerable to unknown regulations or regulatory changes. Best of all, they are free of bias that may exist regarding this issue within your organization.

Businesses in your industry should receive exceptional insight and suggestions from experienced consultants and trainers. Their backgrounds- preferably with decades of experience and knowledge of the pharmaceutical industry and those who regulate this industry should be chosen for third party compliance training.

This will prove to be beneficial for how you are perceived by those who regulate you. If a dedicated compliance department exists with your company, your company will be viewed as taking the aspect of compliance with seriousness.

The compliance program of a pharmaceutical corporation now should be given a top priority due to the progressively increasing settlements required to be paid to the department of justice for suspected illegal activities.

Aside from the monetary trauma experienced by the corporation ordered to pay such a settlement, the corporation then has to repair the trauma it experienced regarding its damaged reputation and image with those it serves.

However, the education and training normally associated with compliance departments never include issues that are rarely considered, yet of great importance. An example is what was mentioned earlier, which is how words on paper are golden in the eyes of prosecutors.

Compliance in effect means to bow to others according to their will. This is the stance that is coerced upon corporations in order for them to self regulate their business operations. It is a stance that is of great importance for the perceptive health of the corporation.

A corporate compliance program should be in a state of progressive improvement as those in this program strive to detect those who are void of compliance that is mandatory.

This compliance attitude should include how each member should write, what words to select, and why, within their organization.

By enhancing the culture of the corporation regarding the management of each member’s actions, this should lead to a greater recognition of the importance of compliance.

The work environment of the corporation’s members allows for compliance programs to thrive as well, history has shown. The corporation’s objective stance regarding maintaining compliance will affect the nature of each employee.

If ethical and legal actions and behavior are encouraged often, this will allow for such an environment to occur that is of less concern to your leadership regarding the possibility of non-compliance.

In addition, training should include the top five federal concerns with pharmaceutical companies, and define these concerns to the attendees from the instructors. This will be information on how to avoid being accused of violating these statutes and regulations.

Those trained will have a full understanding about not only regulations relevant to the pharmaceutical industry, but also those who apply these regulations upon their own discretion.

Ultimately, all within a drug company should be aware of the importance of compliance to ensure smooth business operations in the future,

Dan Abshear

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