Summary and implications

Summary and Implications The FDA has delayed the decision by another three months, to approve the new anticlotting drug, Eliquis, developed by Bristol-Myers and Pfizer. The delay in the decision came about due to the additional information that was submitted by the company. This delay will have a negative impact on the projected 2012 sales of the company.
Eliquis is an anticlotting drug co-developed by Bristol-Myers and Pfizer in 2007. It was developed for the prevention of strokes in people with heart-rhythm disorder called atrial fibrillation (Loftus , par 9). The drug is already available in Europe.
Expected sales for Eliquis for 2012 is projected to reach $395 million (Loftus , par 2). Because of the delay in the decision of the FDA, Bristol-Myers and Pfizer might experience a decline in their sales projections which might also affect its stock prices which have gone up in the past few days at the New York Stock Exchange. The FDA justified their move by stating that the additional data submitted needs more time to review (Loftus , par 6). The original date for the decision should have been March 28 (Loftus , par 11).
Boehringer Ingelheim GmbH and Johnson & Johnson, other manufacturers of new anticlotting drugs, may consider this a favorable development because it gives them time to establish their products in the market while the competition is not yet there.

For the company – What does this mean to the company for its financial outcomes or its future priorities?
This means that the company may have to adjust their sales projections because it will mean a decline in their projected sales. If the launch of the product will be delayed by three months, it means that whatever projected sales for those three months will not be realized.
For the companys competitors- How will they change their strategy based on this new information/activity/outcome?
The delay in the decision on Eliquis is good news for Boehringer Ingelheim GmbH and Johnson & Johnson. They can launch a more aggressive marketing strategy for their anticlotting drugs so that when the time comes that the FDA approves Eliquis, they have already saturated the market and may have gained loyal customers already.
For the pharmaceutical industry- what are the long terms changes we can anticipate as a result of this news
For the pharmaceutical industry, this should be perceived as a caveat in submitting drugs for approval of the FDA. They should make sure that all data that they submit are complete so that there will be no need for amendments later on. It will also serve as a warning to other pharmaceutical companies who intend to manufacture new anticlotting drugs that the FDA is very much concerned about bleeding risks for all patient types.
Your opinion- is this a good? is it good for the company? is it good for patient? Etc.
In one’s opinion, the move of the FDA to delay the decision on Eliquis is good because it shows that it is concerned about the effects of the drug on different types of patients. They just want to make sure that the new drug does not pose any risk to patients who will be taking it. This development is indeed good for the patients. For the company, it is both good and bad. Good because it will also protect them from possible complaints and ill effects of the drugs on patients in the future. Future lawsuits can be prevented. It is bad because of the effect it will have on its sales projections and eventually on its stock prices.
Two questions for discussion:
1) Should Brystol-Myers and Pfizer have done more tests among different patient types before submitting the drug for FDA approval? Why?
2) Is the FDA’s move to delay the decision on Eliquis justified? Why?
Works Cited
Loftus, Peter. ” FDA delays decision on anticlot drug.” The Wall Street Journal (Online) 1 March 2012.