The recent issues involving safety and the blood-thinner Heparin have dominated pharma news lately. While it is one more story about dangers with a drug product that were not anticipated, it stands out on its own. That is because it is so demonstrative of how quickly the way the world works is changing, and how slowly our systems works to keep up with those changes. But from a communications perspective, one has to observe that out of this adversity comes leadership opportunity for pharmaceutical and biotech companies.
Heparin is not unusual in that it is made up of many components. Medicines have become more complex are often derived from exotic sources, such as bat or Gila monster saliva, or not so exotic pig intestines, as is the case with Heparin. The components of a single drug come from multiple manufacturers around the globe. The FDA recently announced that it is going to open up an office in China with 8 employees which frankly sounds like a drop in the bucket. The reality is that there is no way in the world for the FDA to be present at manufacturing facilities overseas and to inspect each and every plant that is producing medicines for Americans. To pretend like it is possible only sets us up for future failure. Globalization has brought change rapidly – we have become a global economy and we are regulating with a domestic mindset. That has to change.
But the wheels of change will move very slowly and be very tied up in the Byzantine process in Congress for months to come. That provides a corporate window of opportunity for bold companies. During this time, rather than wait for Congress to begin to address the gaps in oversight and inspection, industry might move ahead of the curve by taking an inventory of its foreign components and devising highly competent plans for assuming a role in assuring the purity and safety of the goods that are being purchased for use in medicines. Once the plan is designed and being executed, communicate it broadly – to patients, caregivers and to the Hill. Make sure they know that industry has stepped up, surpassed policy-makers in coming up with solutions, assumed responsibility and in doing so, have brought about safer conditions.
It is a leadership role ripe for the picking, and there is time to execute it. Otherwise, sit back and wait and let Congress do it all.