Well it's started
Jun/11/2007 06:00 Filed in: Pharma
Business
Let's say that a cancer drug in development by a pharma company could generate sales of $200-$300 million but it would require more upfront development costs in the form of additional clinical trials and data analysis. Now let's also say that this same pharma company has a "lifestyle" drug in development that, if approved, could generate sales of $700-$1 billion a year. Which drug do you think is going to get the support of management? Probably the drug with the biggest ROI to appease investors and Wall Street. This is the reality of the pharmaceutical business people.
Yes we all want to think that we are doing good and providing people with products than prolong life and add to a better quality of life but the truth is that "only when we can make a profit". To the drug companies credit they do provide programs to distribute drugs to those who cannot afford medications but is still a very small portion of their balance sheets. Now this author is not naive enough to think that pharma companies can seek approval of drugs that provide a poor ROI but what Congressional leaders and the FDA don't understand is that for every action they take there is a potential reaction in new drug development. When drugs are in development and being reviewed by senior management the decisions to move forward have to be based on the likelihood of timely approval by the FDA vs. the potential costs of continued development against an ROI. It is therefore essential in this writers opinion that the FDA explore options to work with drug companies at early stage drug development so as to ensure that the requirements for approval are met when an NDA is submitted. This does happen to a certain extent now but it is all subjective. A company can work with the FDA on protocols and submit the NDA "Package" only to find out that the FDA wants more data requiring more clinical trials, time and dollars. The rules can changed half-way through the game.
The FDA needs to look at drug companies as neither friend nor foe. They need to remember that they are here to protect patients and approve drugs that prolong and improve the quality of life but most of all they, of everyone involved, need to understand that there are risks in all prescription drugs. These risks can be minimized by requiring additional clinical studies but someone at the FDA needs to understand basic risk analysis vs. political pressure. Until a true leader emerges at the FDA and can shield the agency from the political headline seeking politicians it is patients that will suffer with the delay of new drugs.
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