The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugamkers can update warnings and precautions on labeling before obtaining FDA approval. Additionally, Merck won an important court ruling for the entire pharmaceutical industry. A federal court decided that, under certain circumstances, drugmakers may defend themselves against product liability lawsuits by citing preemption.
The summer may be in full swing, but the torrent pace of news and interesting developments has not subsided at all. Hot days simply yield hot stories. Unarguably, the most sensational item over the past few weeks has been the GlaxoSmithKline bribery scandal unfolding in China. As of mid-July, four Glaxo executives, all of whom are Chinese nationals, were detained and authorities hinted that other drugmakers may be examined as they review records held by travel agencies implicated in the drama.
After years of debate and controversy, the US Supreme Court ruled that drugmakers can face lawsuits over so-called pay-to-delay patent settlements, but that such deals should not necessarily be assumed to be illegal. The decision largely vindicates the position held by the Federal Trade Commission, which argued the deals are anti-competitive because generic drugmakers are given incentive to file lawsuits against brand-name rivals and then settle for a quick profit, rather than challenge a patent in court. The FTC calculated the reverse settlments, as some call them, cost consumers $3.5 billion annually.
Once again, a plethora of interesting events has occurred since the last time we stopped by. What was the biggest headline? That decision may be up for grabs, but certainly, the $500 million penalty paid by Ranbaxy Laboratories is high on the list. In other news, yet another Johnson & Johnson manufacturing scandal has erupted, this time in South Korea, where the authorities plan to bring criminal charges against its Janssen unit and ban production of five products – notably, a type of Children’s Tylenol. A non-profit group put Bayer on notice that a lawsuit will be filed charging the drugmaker with making “unsubstantiated and illegal claims” about the ability of its One-A-Day vitamin to prevent various disease, such as breast cancer, bolster physical energy and improve immunity, among other things.