FDA Regulations on Drug Marketing

Pfizer under fire for lacking safety protocols

On April 9, the FDA announced that Pfizer has failed to correct testing procedures in regards to clinical trials. The FDA says that over two dozen overdoses have occurred in patients participating in trials for the drug Geodon. The warning from the FDA comes on the heels of the federal court criticizing Pfizer’s in-house safety protocols and procedures.

The FDA issued a warning letter to Pfizer saying Pfizer is not properly monitoring physicians testing an experimental medication and as a result, more than two dozen patients have overdosed during the four-year trial. Pfizer first identified problems with the drug and dosing recommendations in 2006, but the FDA says they have failed to fix these procedures. The FDA has given Pfizer fourteen days to submit a new set of policies and procedures for overseeing care of patients within their clinical trials.

Over the last month, Pfizer has come under fire for lacking safety protocols. A former lab employee won a lawsuit against the company blaming ineffectual safety procedures for her contracting an immunovirus and now with clinical trials. Problems with safety are becoming a pattern for Pfizer, one they need to change before a major crisis, like death resulting from a trial drug, hits. Employees, stockholders, and consumers want to know that Pfizer is doing everything it can to keep them safe.

The FDA is providing Pfizer with their first opportunity to turn the pattern around and recommit themselves to safety. By re-evaluating their current safety procedures, Pfizer has the opportunity to figure out what can be improved upon. After evaluating safety protocols within clinical trials, Pfizer’s next safety area needs to be lab procedures. As the field of biopharmaceuticals grows and develops, the risks associated with lab work will grow. There is a need for advanced protocols throughout the entire industry and Pfizer can take this opportunity to put themselves ahead of their competitors.

Pfizer needs to re-evaluate all of its safety procedures and protocols in order to prevent a bigger crisis and avoid future legal troubles.

How engaging in social media now can help crisis communications in the future

Prior to the 1990’s there was very little academic research into crisis management, but as more and more organizations have experienced devastating crises the importance of the field has become more apparent. Today, crisis management is a rapidly changing field with a number of emerging trends for the way in which an organization reacts, both internally and externally.

The development and frequent use of social media tools (i.e. Facebook, Twitter, and blogs) has played a large role in the way stakeholders and publics are being delivered news. Social media allows anyone the freedom to be a gatekeeper and as a result, information on crises is being delivered much quicker and to a much larger audience than before. In addition to information being available quicker and to a larger audience, there is also less fact checking. With less fact checking it becomes difficult for PR pros to control the flow of information and ensure that all publics are being given the most accurate updates on a crisis.

The best way to monitor what publics and social media gatekeepers are saying is to set up accounts on various social media platforms. An organization should have a Twitter account, a Facebook account, a company blog, and Google Alerts set up for anything being said about the company. Pfizer has a Twitter account (@Pfizer_News), a Facebook fan page, and an official company blog. Having these accounts is a great foundation to have lain in the event of a crisis, but the primary purpose of these accounts is disseminating news rather than interacting with its various publics and stakeholders.

Should a crisis hit, Pfizer’s social media accounts will only be useful if they have already built relationships with Twitter, Facebook, and blog users. Communicating with social media gatekeepers is the same as communicating with traditional media. Relationships must be built before an organization can ask a stakeholder or public to do something for them. Pfizer needs to take the time to interact with their followers on Twitter and Facebook and fellow bloggers so they can use these gatekeepers to their best advantage should a crisis hit.

Pfizer Safety Policies

Last month I blogged about a lawsuit brought against Pfizer by a former employee who claimed that Pfizer’s lack safety protocols led to her contracting a virus connected to immunodeficiency diseases. On Thursday, Federal courts in Connecticut awarded Becky McClain $1.37 million stating that Pfizer violated whistle-blower laws by firing Ms. McClain. The courts also highlighted the potential dangers facing scientists who work in biotechnology labs and the need for stricter protocols and procedures.

After a crisis hits, and this is crisis for Pfizer, the most important step an organization can take is to learn from the situation. Regardless of how the organization weathered the crisis, it can only be deemed successful if it then takes the opportunity to re-evaluate its business policies and procedures to ensure a similar crisis does not happen again. Often, the ethical environment of an organization sets the stage for a possible crisis.

The board of directors, motives of top executives, or organizational safety policies, can set ethical environments. In the case of Pfizer, they will need to intently look over their current safety policies and how strictly they are being enforced. With the way the biotechnology industry is evolving, they need to spend the short-term finances now to prevent a future crisis from happening.