2012 US Drug Approvals Best in 16 Years, But will the good times last?

Coming out of the blizzard of patent expirations, 2012’s total drug approvals climbed to 39, the greatest number from the FDA since 1996. The evidence is now clear that pipeline preparations laid not just within the year but within the past decade are finally yielding results.

The approvals also show that the US continues to outpace Europe and Canada in approving new medicines, as the FDA works to speed up its application processes. This comes at a time when the EMA is putting more emphasis on reviewing medicines already on the market, bowing to government pressures to take the concept of value more seriously and to reduce wasteful health expenditures. Conversely, the fifth installment of PDUFA has given the FDA more resources to apply to the task of improvng the registration timeline.

According to Raghuram Selvaraju, head of healthcare equity research at Aegis Capital Corp, another reason FDA has pushed up the pace is industry ”beating Margaret Hamburg over the head” with complaints about review cycle delays, general disorganization and a level of risk aversion not commensurate with a drug’s potential benefit for patients. “The good news is that drugs that should get approved have been getting approved without delay, and in some cases, if the evidence is really overwhelming…ahead of the PDUFA date.” In its most recent effort to spur approval, the agency also issued guidance by which companies can more effectively demonstrate clinical value to their drugs by eliminating certain patients from trials.

Another explanation behind the approval uptick has been a steady increase in biologics brought to market. This increase highlights the growing familiarity the FDA has gained with such medicines and the sophisticated science behind them. But the best news of all is that drugs approved this year, in addressing real medical needs yet to be met, reaffirm that patients are still important to the industry.

Warm and fuzzy notions aside, it will be interesting to see how sequestration affects drug approvals in the year to come.  The question:  how will the FDA manage expectations to keep up this good pace of approvals when sequestration carries a mandate to cut the agency’s funding by $318 million?