Although FDA Commissioner Hamburg unfortunately was unable to make the opening session of this month’s PDA-FDA conference in Washington, DC, there have been many other great talks from agency reps as well as industry. This morning, Edwin Rivera-Martinez of FDA’s DMPQ office provided updated stats on foreign inspections and foreign manufacturing sites–and offered new information about FDA concerns about how industry is handling the growing number of mergers and acquisitons.
We all know that the number of drug product manufacturers outside the US has been increasing over the years, but it was interesting to hear that between 2001 and 2007, they increased 7 fold in China and 25 fold in India. FDA inspections have also been on the rise outside US borders, increasing a full 53% between 2005 and 2009 to a total of 222 completed foreign inspections. The majority of these are PAI and surveillance inspections while about 2% are “for cause” inspections (i.e., based on recalls, etc.), said Rivera-Martinez. In 2009, 44 of these inspections were performed in China while 95 were conducted in India. The bulk of course took place in the European Union.
Rivera-Martinez noted that the number of NDA and supplements submitted to FDA that reference manufacturing sites in the EU grew from 229 in 2005 to 293 in 2009. In light of these stats, he made a point to note that FDA rigor and oversight has been on the rise, not just for the past 1-2 years as many have claimed, but really for the past 10 years.
One topic gaining traction at the agency seems to be how to deal with the increase in industry M&As. New compliance problems are occuring as a result of these deals, said Rivera-Martinez. For example, as companies change over or merge, there have been delays in reporting and issuing field alerts to the agency. Integrating quality systems has been a big challenge in terms of maininting control of sites and systems during the transition phase of M&As. Training interim and new staff is also an issue. Another impediment, he said, is that legacy products are being acquired without accompanying process knowledge of those products.
Overall, according to Rivera-Martinez, FDA has concerns about who is in charge of what and what sort of timeframes companies are setting to ensure that product quality and manufacturing site control do not lag during M&As. Management needs to pay attention to transition and implementation phases and their affect on quality systems and product quality.
In fact, Rivera-Martinez pointed out that now is a good time for all drug manufacturers to ensure that they have a global, modern, comprehensive, robust, CGMP quality system in place. By global, he said he means ALL the company’s manufacturing sites. For example, if a 483 is received at one site, the company should ensure that problem does not exist at any of its other sites.