Sometimes you don’t realize how important something is until there’s a problem. Outsourcing is nothing new for the pharmaceutical industry, and many companies have come to rely on it. It helps companies stay lean and contributes toward profits.
Outsourcing is not a trouble-free strategy, however, as the contaminated heparin scandal attests. I can’t help but think that it was a careless attitude toward safety and quality standards that led to the problems. There is plenty of blame to go around. The drug company, the ingredient supplier, and regulators seem to have been asleep at the switch, and the results were both awful and avoidable.
This incident underscores what we already know: we need regulators to inspect ingredient suppliers and drug manufacturers to ensure that our medicines are safe and effective.
The problem is that sometimes we forget what we know.
Reacting to the scandal, Thomas Lonngren, head of EMEA, said, “Suddenly we discover that we have important manufacturing far away that we don’t have any control of.”
“Suddenly?” Is it really news to Lonngren that pharmaceutical companies outsource production? Hasn’t industry, and haven’t regulatory bodies themselves, been grappling with the challenges of globalization for a while now? It should already have been clear that different countries have different quality-assurance standards and procedures. Globalized production and sourcing introduce more variables to the drug industry. Thus the need for monitoring is even greater.
EMEA, FDA, and regulators in Canada and Australia realize this and have begun cooperating on a pilot project for joint inspections of international API -manufacturing plants. I applaud this approach. I think cooperation is in everyone’s interest. Joint inspections will bring more resources, more experience, and greater agility to regulation. EMEA says that the pilot project will also help guard against drug counterfeiting, an added bonus.
The bottom line is that patient safety must be ensured, and a collaborative approach will help regulators and industry to remain vigilant and thorough.