Can the drug industry regulate itself?
Feb/18/2007 12:25 Filed in: Pharma
Business
Who are the drug companies? They are not huge buildings on a hill with all the warmth of an ice storm. Companies are made up of people but somehow during the last decade the marketers that have come into the pharmaceutical industry have done a lot of damage.
There is always pressure to make numbers in any company. It's what drives our salaries, bonus and expense budgets. But why would marketers make a bad decision that could cause harm to patients and lead to a mountain of litigation. Knowing the way most drug companies operate, in a matrix environment, I find it hard to believe that any one person could be responsible for these problems. All pharma companies have a process for getting promotional materials approved that involves legal, regulatory and medical support personnel. Unless there is a broad conspiracy by a lot of people these mistakes are the result of bad decisions that are the direct result of people who forgot why we are in this industry.
Bad decisions are a risk in any industry. The auto industry is always in the spotlight for safety issues and it seems that every day there is a recall of some type. Consumer Reports recently had to retract a story it ran on children's safety seats because the company that ran the tests reported the wrong data. All this, along with Tyco, Enron, and MCI, feed into an ere of consumer mistrust of "the establishment". In politics the White House now admits that the information they used to justify the war in Iraq was faulty. More fuel for the fire.
What this means for marketers, and the drug industry in general, is that we now need to redraw the line in the sand and move it more to the right. If there is the slightest possibility that a drug, or device, can cause a side effect we have to report to the FDA and physicians. We can't say anymore "that we are studying the issue to determine if there is a correlation". We now have to warn our patients and customers that there maybe a link and we are studying the correlation to determine the risk factors.
I also believe that more checks and balances are needed in the promotional process. People who approve promotional messages need to clearly indicate that they are approving these materials with documentation. Brand team leaders should be help accountable for everything that comes out of the brand including DTC and HCP materials. More than anyone these people need to be made aware that the environment in which we market is hostile and one bad decision could cost the company millions of dollars in lawsuits. More importantly the industry needs to be reminded why we are here: to make a difference in patients lives.
We all receive annual reviews and it has to be up to management to weed out marketers who make questionable decisions. The industry has to be more proactive in cleaning house because if we are not Congress will be glad to do it for us and the results will not be pretty. In recent research that I conducted with diabetics I learned of the problem these people had with living normal lives. It reminded me that I need to do whatever I can to help these people and provide answers to their concerns. Maybe it's time for everyone to listen more to patients and less to Wall Street to get back on track.
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