Speed And Safety At The FDA: Generic Drug Approvals Reach Record Highs

May 10 01:00 2016 by ushadmin

New legislation increases the speed of the FDA approval process for generics by introducing fees for applying manufacturers. This is not a new approach – manufacturers have been paying application fees for branded drugs since 1992. Such an approach gets treatments into the hands of doctors and patients faster – with relatively small impacts on safety – while ensuring that funding for a speedier FDA comes directly from the applicants who benefit from it.

Generics make up about 90% of prescriptions in the US, a market share that has grown steadily since 1984 when the Hatch Waxman legislation introduced a speedier approval pathway for generics. The trend shows no sign of stopping, partly due to beneficial new legislation: the 2012 FDA Safety and Innovation Act. Prior to the recent legislation, the FDA’s Office of Generic Drugs had long struggled with sluggish approvals, organizational change, and a massive backlog of applications. Now, flush with new funding thanks to the FDA Safety and Innovation Act – which charges drug manufacturers fees for drug applications – the office is approving generics at a record pace. Of the 2,866 “backlogged” applications pending prior to October 2012, 84% have been acted upon and 609 have been approved. In 2015 alone, the FDA’s Office of Generic Drugs approved 580 generic drugs – the highest number on record – while another 146 were granted tentative approval. However, the growing market share of generics is not only due to these legislative actions, it also depends on the pace at which patents expire (raising the generic share) relative to the pace of new brands entering the markets (lowering the share).

A central tradeoff facing the FDA involves balancing its two goals: 1) protecting public health by assuring the safety and efficacy of drugs; and 2) advancing public health by speeding up access to new products. With these competing objectives, the FDA has long faced critics around every corner – some observers arguing that the FDA is not taking enough time to ensure the safety of new products, while others argue that the agency is taking too long getting potential lifesaving products into the hands of doctors. The case of generics is no different. Fast access may sacrifice the safety assured by the Hatch Waxman act, but slow access delays beneficial competition….