Heparin - Out of Adversity Comes Opportunity

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. 

Comments

[HMS]

"Andy's Take" is an attempt at getting positive PR for the Agency. I wonder how much media pickup it's getting. However, as well intentioned as he is, Andy von Eschenbach is a lame duck commissioner. There's no doubt that, with a new administration taking over in 9 months, he won't be around long enough to implement major changes at FDA. Too bad.

[Sean]

Mark –

Two straight columns on proactive leadership. I’ve enjoyed them and agree with you.

The real question – is anyone listening? More realistically, can “industry” tackle this in a coordinated fashion? Clearly, it benefits everyone if the pharma companies band together and come up with solutions before Congress tries to impose solutions. Given the real turmoil and changes that big Pharma faces, it is hard to picture them being able to work together to do something dramatic. (And no single company has an incentive to do it on their own.) Call me a pessimist, I just don’t see it happening.

Sean

[Douglas Winship]

"Globalization has brought change rapidly - we have become a global economy and we are regulating with a domestic mindset. That has to change."

I wonder if anyone has thought about the implications of this statement. The incentive to outsource becomes heightened when the likelihood of regulatory repercussions decreases, which it inevitably must because there is no way the FDA or EMEA can ever assure the compliance of developing world manufacturers like they can the manufacturing facilities under their direct legal authority. European-, US- and Japanese-based manufacturing facilities will increasingly be at a competitive disadvantage to such because they are routinely inspected, the inspectors know the language and they continually push for (suggest) tighter controls (generally adding more incremental cost).

If the recent spate of QC related recalls tells us anything, it should tell us that assuring comparable quality with such limited international inspectional resources is probably unattainable.

Stationing 8 inspectors in China (or India or other such countries) may look good politically short term, but it will always be easier for manufacturers in these countries to cut corners until such time as their national regulatory bodies have both the will and adequate indigenous resources to enforce comparable standards locally and frequently, while also having adequate legal safeguards limiting the possibility of such inspectors from being "bought off."

[CMC guy]

I do agree Industry should act before "solutions" imposed by Congress however what you propose as a plan would appear just fundamental compliance with cGMP- sponsors should already have established traceability and active monitoring systems- they need to rigorously verify they are adequate. Perhaps all parties have gotten so focused on costs they become oblivious to quality requirements plus assume someone else is handling that responsibility. Although the number of Inspectors may a token it could be catalyst to both sponsors as well as Chinese/Foreign suppliers to improve which is unlikely to happen quickly and without more angst on all sides.

[Robert Schiff]

My experience has been to write such clinical reports and the investigators who performed the study review and then put their names on it as well as our own. We have not run into the situation where a clinical investigator who has not been part of the study is placed on the report. That does not mean it doesn't happen. This happens in academics all the time.