With 2012 near, generics still face challenges

In February, Drug Store News discussed three issues concerning generic drugs that would figure prominently throughout the year: drug safety, user fees and patent settlements.

None of those issues have gone away. Fears recently surfaced that Ranbaxy might not get to launch its generic version of Pfizer’s cholesterol medication Lipitor (atorvastatin) this month due to concerns about safety at two of its plants in India, but it appears the scheduled launch is back on track. The Food and Drug Administration’s Office of Generic Drugs needs increased funding to address its massive backlog of generic drug approval applications, something that user fees would address, but the Generic Pharmaceutical Association has been pushing Congress to maintain funding for the OGD. Meanwhile, the Federal Trade Commission and such members of Congress as Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, continue their push to ban patent litigation settlements that involve any type of payment from branded drug companies in exchange for generics companies holding off product launches, even when those product launches happen months or years before the branded drug’s patents expire.

But IMS Health VP industry relations Doug Long recently told Drug Store News of another major issue emerging. “What’s really come to the forefront is this drug-shortage stuff,” Long said. According to the GPhA, the reasons for drug shortages are numerous and complex: insufficient supplies of raw materials; inadequate and delayed communications about shortages; changes in clinical practices that have altered volume production; and stockpiling of drugs within the gray market.

In September, the GPhA called for a broad effort by various stakeholders — ranging from branded and generics drug makers to component suppliers, from healthcare providers to regulators — to combat the problem.

Whatever the issues for 2012 turn out to be, it’s the trends in various disease-state markets that will continue to drive prescribing, dispensing and marketing of generic and branded drugs alike. Click here to see the highlights.

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