Generics face new and long-standing issues

In the Feb. 7, 2011, issue, Drug Store News named three major issues that would define 2011 for the world of generic drugs. Those issues were drug safety, generic user fees and patent settlements.

All three managed to surface in some form over the course of the year. Drug safety became an issue with Ranbaxy Labs’ planned launch of a generic version of the blockbuster cholesterol-
lowering drug Lipitor (atorvastatin), when analysts speculated that long-standing issues with two of its manufacturing plants in India would thwart its plans to launch the drug on Nov. 30, as scheduled. But the company partnered with New Brunswick, N.J.-based manufacturer Ohm Labs to make the drug and received FDA approval in the evening of Nov. 30, just hours after Watson Pharmaceuticals launched its authorized generic. 
Generic user fees rose to particular prominence at the end of the year when the FDA released guidelines for the Generic Drug User Fee Act, and based on that, there’s a good chance that further progress will be made in Congress and at the FDA.

Patent settlements became an issue as well, with attacks on so-called “pay-for-delay” deals by the Federal Trade Commission and members of Congress, and given that they have been a perennial issue, there’s reason to suspect they will become one in 2012 as well.

This year, generic drug makers again will face a number of issues and challenges. These include perennial issues like patent settlements and biosimilars (see stories here and here), as well as long-standing issues that may become more prominent, such as the patent cliff (see story here). Drug shortages have received a lot of attention from the government and the media, which is a good thing, but experts say the problem is unlikely to find substantial resolution despite efforts by the Obama administration to address it (see story here). Meanwhile, the negotiation and release of guidelines for GDUFA mean generic user fees are likely to get some attention as well (see story here).

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