The FDA is becoming increasingly heavy-handed when it comes to the pharmaceutical industry, and the growing burden of regulations, increasing costs, and growing pressure of what has been termed “geographies of interest,” are forcing some firms to turn to outsourcing in order to survive in this keenly competitive global market. Still others are hiring pharmaceutical consultants and experienced life sciences consulting experts as a means of dealing with the flood of regulatory issues, while still remaining competitive.
One of the three main drivers in the push toward outsourcing is, of course, FDA regulations. A few of the major developments in the last few years are:
August 2002: The FDA set in motion a new initiative entitled the Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century: A Risk-Based Approach. This initiative focuses on the risks to public health that could result from flaws in manufacturing procedures. The stated purpose is to ensure that standards for process and product quality don’t hinder innovation, and it will mostly likely raise costs for pharmaceutical companies.
September 2004: The FDA promulgated a document titled Process Analytical Technologies (PAT), which encourages early adoption of advances in industry technology. Although acquiring and using new, state-of-the-art technology is sometimes necessary, it undoubtedly has its costs.
September 2006: The FDA promulgated another document, titled Quality Systems Approach to Pharmaceutical CGMP Regulations, as an extension of the Pharmaceutical CGMPs for the 21st Century initiative. Its purpose is to provide guidance in bridging the gap between 1978 CGMP regulations and later ideas about quality systems. More costs?
In order to survive and remain competitive while regulatory, compliance, and associated cost burdens continue to increase, more and more companies in the pharmaceutical industry are looking to outsource more of their activities. Although outsourcing may be a viable solution, it carries with it potential dangers that could be very costly. According to Nigel Smart of the Smart Pharmaceutical Consulting
The company is still responsible for meeting drug-manufacturing regulations, as well as other government requirements. Ultimately, the holder of the license—the pharmaceutical company or biotech—is the one who will have to answer to the government, or deal with lawsuits.
Smart offers this warning: “As one goes farther afield from one’s home country for outsource services—for example, a US company outsourcing to Malaysia—one has to deal with language barriers, differences in culture, and the potential for error increases because something was miscommunicated or mislabeled.”