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.

Podcast - What healthcare reform means for the pharmaceutical industry

Learning from a Crisis

A few weeks ago, I wrote a post about Pfizer being under investigation by the DOJ for its marketing of an immunosuppressant drug, Rapamune. Until the results of the probe are revealed, it is hard to say what effect it will have on Pfizer; however, in the meantime their communications department and Crisis Management Team should be evaluating what can be learned from this potential crisis.

Many experts believe that crises are both negative situations and opportunities for organizational learning. The success of crisis communications is defined by whether or not an organization learns from each crisis. Levels of learning differ, but the most advance level is to change organizational policies and procedures to prevent a crisis from happening in the future.

In the case of Pfizer’s DOJ probe, the learning should be easy. The Crisis Management Team should begin by evaluating what advertising and marketing is being done on Rapamune and all other drugs. This process could include monitoring any complaints that have been turned in by consumers. Should any violations or problems present itself, Pfizer needs to change its marketing policies and techniques to ensure the problem does not happen again.

Any crisis can be turned into an opportunity if an organization takes the time to evaluate and learn from the crisis. This includes taking steps to change organizational policies and procedures to ensure future crises do not repeat themselves.

Ex-Pfizer Worker Cites Genetically Engineered Virus in Lawsuit over Firing

On Monday of this week, court proceedings began in the suit of a former Pfizer employee who claimed she was fired as the result of being infected by a genetically engineered virus she was working on. Becky McClain alleges that a lack in laboratory safety led her to be infected with a virus that is now causing her intermittent paralysis. McClain also alleges that after she reported her concerns to Pfizer and the US Occupational Safety and Health Administration (OSHA) she was fired for “blowing the whistle” on Pfizer’s below standard safety procedures. McClain has filed her claim under Connecticut’s whistle-blower laws.

McClain’s lawsuit is, in fact, a crisis for Pfizer. A former employee is not only saying that the company failed to protect her personal safety, but they fired her because she tried to tell the world about it. Attacks on companies do not get much worse than this. However, Pfizer is handling this lawsuit and its ensuing crisis beautifully.

Pfizer lucked out in that OSHA is on the drug giant’s side. McClain’s complaint was dismissed after OSHA reviewed the evidence and even went as far as to criticize her for not accepting the accommodations Pfizer was willing to offer (Pfizer offered to move her to a different facility where she would be exposed to less vigorous viruses). With OSHA on their side, Pfizer has a credible third party to state that the company’s safety practices are up to par. A fact that they have been stating to every news outlet that asks for an interview. Pfizer should also consider publishing fact sheets or creating a video of what safety measures are taken in their labs.

Pfizer also claims that McClain was fired for failure to attend work and that the connection made between her symptoms and the virus were made after the fact. If Pfizer can prove that McClain never mentioned a possible connection prior to being fired, she loses her case, as it cannot be filed under the whistle-blower statutes. The company is also doing a great job at utilizing a single spokesperson – public relations specialist, Elizabeth Power. Power is the only person commenting on the case, an important element to ensure continuity in the information being disseminated.

Despite the potential fallout from this lawsuit, Pfizer is doing a great job at sticking to the facts and providing cohesiveness to the messages being disseminated. As long as they keep doing what they are doing, Pfizer should be able to make it out of this crisis without a huge hit to their reputation.

DOJ conducts criminal probe of Pfizer unit's drug marketing

Last week, it was announced that federal prosecutors in the western district of Oklahoma were investigating Pfizer for their marketing of the immunosuppressant drug, Rapamune. Pfizer inherited the drug when they purchased Wyeth last year. Both federal prosecutors and a Pfizer spokesperson declined to comment on the action. The probe was announced by Pfizer in a regulatory filing last Friday.
In the broad spectrum of crises that Pfizer could face this probe, and any future legal actions, are somewhat major. At the moment, the probe is barely a blip on the crisis scale. It is unknown the source of the probe, but it is unlikely it’s anything more than a few consumer complaints. The true crisis will hit as a result of the probes findings. If it is determined that Pfizer did nothing wrong and no legal action is taken, the probe will be forgotten by the public at large. However, if federal prosecutors decide that Pfizer violated laws in the marketing of the product it could result in a multi-million dollar law suit and a number of legal sanctions.
It will be months before any action is taken as a result of the probe, so in the meantime Pfizer needs to be preparing for this potential crisis. Any good communications department already has a crisis management team and plan in effect. They know exactly who needs to be contacted and which team members are going to play the most vital role (in this case legal counsel will probably be at the forefront). Pfizer needs to focus on establishing and monitoring an information-gathering system. Managers and effected staff need to be sharing information with each other. Everyone must be on the same page and have key messages identified in the case of the probe reaching a full-blown crisis. The most important element is making sure that the information being collected is accurate and relevant. This might mean doing in-depth research on the marketing of the drug compared with how other immunosuppressant drugs are being marketed or looking into laws relevant to the marketing of drugs.
Regardless, Pfizer’s managers and communications experts need to be preparing for this minor blip to become a full blown crisis.

Putting all your eggs in one basket

According to their website, Pfizer works across developed and emerging markets to advance wellness, prevention, treatments and cures. Pfizer operates in the pharmaceutical industry. They currently have over 31 drugs on the market focused on a variety of different illnesses. They also produce a number of animal health products. Over the last decade, Pfizer has acquired two companies – Wyeth and Warner-Lambert. Both corporations have only strengthened the pharmaceutical giant and allowed them to explore more innovative ways of drug discovery.

An important element in preparing for a crisis is strategic management, which involves analyzing the environment the organization operates in. Many organizations operate under a corporate strategy that is typified by identifying the industries the organization is in. An organization can operate in a single industry, multiple related industries, or multiple unrelated industries. Pfizer operates in a single industry.

Operating in a single industry is often the best way to avoid a crisis. By limiting the number of areas your corporation is involved in, the more control the organization has. However, when a crisis does occur the damage is usually worse. When a company only has investments in one industry, there are no others to soften the blow and make up for lost revenue. In Pfizer’s case, their single business industry contains enough diversification within its product lines to make up for any slight dips.

Imitation drugs can cause a Real crisis

As discussed in earlier posts, sources of crises can be either internal or external. Often, external crises present the greatest challenge as they are difficult to predict. However, predicting a potential crisis is the focus of crisis management and is essential to the development of a crisis management plan. In addition to team members, command center locations and guidelines for activating the plan, outlining potential crises with suggested responses is a vital element to a crisis management plan.

Currently, the pharmaceutical industry is plagued by the selling of imitation drugs. Pfizer recently sponsored a survey asking Eastern Europeans if they had ever purchased imitation drugs. Despite the obvious loss of profits, pharmaceutical companies also face possible hits to their brand as these drugs are often packaged in ways similar to the “real” drugs. The imitation drugs often contain toxic chemicals creating a serious health risk. If one of these imitation drugs was being sold as, let’s say, Pfizer’s Lipitor and a consumer died after taking it this would be a crisis for Pfizer.

One possible solution to this problem is to first begin by confirming whether the drug responsible was an imitation or a “real” Pfizer drug. Assuming that it was an imitation drug responsible for the death, Pfizer would first need to announce that to its various publics. The key message would be Pfizer was sorry for this tragedy, but none of their drugs were responsible. To reinforce their positive brand image, they should launch an educational campaign focusing on the danger of imitation drugs and the extent of the problem.

It is important to be flexible when preparing a crisis management plan. Although this is one solution to this potential crisis, there could be many more that would be more appropriate given specific circumstances.

Pfizer launches online wellness system

Part of crisis management involves constantly monitoring the culture of your company and its external influences. A corporation must constantly be evaluating whether or not all of their business practices are in line with the company’s message and the image it wishes to project. This includes how it treats its employees, new business ventures and any partnerships. Partnerships are especially important, as it is difficult to control how another company is behaving and their behaviors are an indirect reflection on your company.

This week, Pfizer announced that they would be partnering with Keas Inc. to launch an online prevention and wellness program. The program’s primary function is to help patients with challenges such as weight loss, smoking cessation and diabetes prevention while giving them personalized tools for success. A spokesperson for Pfizer explained that the partnership made sense based on Pfizer’s commitment to innovation.

Often, when large corporations partner with other organizations the most important factor considered is the economic stability of both organizations and what each organization stands to gain from the partnership. If the numbers are correct, the partnership goes ahead. Corporations fail to analyze whether or not the partnership is aligned with the company’s goals and missions. And then are shocked when a crisis results. Sometimes, partnerships that seem like a home run can result in a crisis.

In 2000, sports apparel giant Nike offered professional golfer Tiger Woods an endorsement deal. Woods was the most famous golfer since Arnold Palmer and Jack Nicholas so the partnership seemed like a slam dunk for Nike. We all know what happened next. What seemed like a lucrative partnership for both, but Woods’ ensuing scandal made it clear that his values were not in align with Nike’s.

It is unlikely that a giant like Pfizer is entering into this partnership lightly. It can be guaranteed that it is a collaboration that has been intensely studied. And on the surface, it seems to make sense. Both companies exist to improve the lives of its publics by helping them maintain a healthy life. In the interest of keeping users as safe as possible, all care plans are being written by physicians, Pfizer and other medical experts. For now, this seems like it will be a successful partnership for both Keas and Pfizer, but Pfizer should constantly be reevaluating that partnership to make sure it does not result in a crisis for either company.

Could healthcare reform be Pfizer's next big crisis?

When evaluating a potential crisis there are two types of causes – external and internal. Internal causes are often things the company is doing wrong and know is wrong, while external causes are circumstances the company has no control over. External forces can be broken down into political-legal, economic, social, and technical. As a pharmaceutical company, Pfizer has the most to fear from political-legal causes.

For the last year healthcare reform has been at the center of congressional debates. Preliminary bills have been passed in the U.S. House of Representatives and the Senate is currently debating the issue. It’s unclear to what extent these new regulations will have an effect on the Pharmaceutical industry, but it can be assumed it will present a fair share of problems. One of the largest components of proposed legislation is reducing the cost of drug prescriptions. Pharmaceutical companies depend on selling drugs to provide the majority of their profits. They spend millions of dollars creating new drugs in order to then make millions of dollars selling drugs. Federally stipulated drug prices could throw the industry into a period of rapid recession.

Pfizer needs to be planning for a potential hit in the profits made from their various drugs. Developing a task force to deal strictly with potential changes that will come of new healthcare regulations, will give Pfizer a tremendous advantage. Political analysts, lawyers, lobbyists, and business analysts would be ideal candidates for a healthcare reform crisis team. The team should, or course, be lead by a PR practitioner (or practitioners) with extensive backgrounds in the pharmaceutical industry. The goal of effective crisis management is to be prepared for anything that may hurt your company and have a prepared plan of how to handle it.

Crisis Communications for Pfizer

As I mentioned in my previous post, in this blog I will be focusing on Pfizer Pharmaceuticals. I will try to apply the information I learn from the textbook and in-class discussions to developing crisis communication strategies for Pfizer. For example, Professor Laskin explained that crises can be caused by an outside or inside error (deliberate or not). Pfizer, for example, can potentially face crises from such inside causes as drug related deaths and from such outside causes as network hacking resulting in incorrect drug pricing.

Welcome

Greetings Readers!

It is with great excitement that I am debuting my first ever blog. I am an avid social media geek with an addiction to Facebook and Twitter (hhitchen31), but have never made the leap to blogger. For the next fifteen weeks, the duration of my crisis communications class at Quinnipiac Univeristy (see below for disclaimer), I will be taking a critical look at Pfizer Pharmaceuticals from a Public Relations standpoint.Our assignment is to choose our dream company to work for and since Healthcare PR is my passion, Pfizer is my dream. I hope you all enjoy what I have to say!

This is a student's blog for Crisis Communication class at Quinnipiac University. As such, I as the author of this blog make no representations as to accuracy, completeness, currentness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use. All information is provided on an as-is basis. Opinions expressed on this blog are Holly Hitchen's personal opinions and do not represent opinion of the Quinnipiac University or opinion of the instructor of the class.