In focusing on individual drug shortages, the FDA is missing opportunities to proactively prevent and mitigate shortages in general, according to the Government Accountability Office (GAO). Instead of waiting until it develops a new information system to track drug shortages, the FDA needs to routinely analyze the information it has in its existing drug shortage database so it can be more proactive, the GAO said. By identifying risk factors for potential shortages early on, routine data analyses could help the FDA recognize trends, clarify causes and resolve problems before a shortage develops.

If brand drugmakers have their way, the EU could be counted among the countries and regions that are the worst in undermining the value of U.S. companies’ intellectual property rights. Citing the EMA’s proposed trial data disclosure policy, government price controls and the lack of timely patent dispute resolution as factors that reduce the value of patents and create uneven market access for innovator drugs, the Pharmaceutical Research and Manufacturers of America (PhRMA) asked the U.S. Trade Representative (USTR) to put the EU on its priority watch list in the annual Special 301 Report. The trade group is especially concerned about proposals to publish clinical study reports (CSRs) in their entirety once the EMA has granted marketing authorization. In the past, the EMA has considered the reports commercially confidential information. Once disclosed in Europe, the CSRs could be used by competitors to seek approvals in other markets such as China, PhRMA pointed out.