Of course you know this means war !

Mar/13/2007 06:11 Filed in: Pharma Business
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Well it's started..this week the Justice Department has issued subpoenas to J&J for marketing related to three drugs, Amgen & J&J had to put black box warnings on anemia drugs because physicians were using the drugs off-label and a jury has overturned an award in a Vioxx litigation. It's time for the pharma industry to circle the wagons but what is missing is the one leader who can step forward and remind us how many people are living longer and healthier lives thanks to the drugs that are on the market today.


There is a fine line between cooperating with the FDA and tucking your tail between your legs and kissing someone's ass. If the FDA mandated that CEO's wear clown suits I believe they would comply ! The battles looming with the FDA are all politically motivated and the new head of the FDA has shown that he is going to play along with Congress and do whatever is necessary to get in their good graces even if, in the long run, patients are hurt. Make no mistake about it patients will be hurt. Amgen alone lost $18 billion in market capitalization when the black box warning was issued. That means less money to investigate new drugs and less products in development.

There have been accusations that the FDA is too cozy with big pharma. I frankly don't buy that for a second. The FDA is understaffed and overworked and has to rely on a good relationship with pharmaceutical companies to streamline work loads. Drugs that may have received approval through the normal NDA process are now being held up because the FDA wants "more clinical studies". Most pharma companies work with the FDA while a drug is in development to ensure that protocols and studies are set up correctly. The problem is that once the data is submitted via a NDA the FDA can use subjective criteria and tell the company that it now wants more studies. The pharma economics of this long process means higher development costs, less revenue and will lead to higher drug costs across the board.

Rather than point fingers it's time for pharmaceutical companies to ban together and come up with a plan to better work with the FDA, Congress and the media. Lobbyists are not the answer pharma needs to remind everyone of the value they provide to society in the form of better health and lower health care costs. Pharma will spend billions on DTC message development but not one leader will step forward and reach out to other industry leaders with a plan that clearly addresses the challenges facing the pharma industry today. Help wanted....
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