Premier : presses for federal response to drug price spikes

As part of Premier’s efforts to help our members manage drug costs, we continue to work in Washington DC to urge lawmakers and the administration to put in place policies that create a healthy marketplace for drugs, particularly for lower-cost generic alternatives. Premier’s group purchasing organization (GPO) trade association, the Healthcare Supply Chain Association (HSCA), sent two letters appealing to Congress and the FDA to take action to facilitate new generic entrants into the market, increase competition among manufacturers and support quality metrics for manufacturers.

On September 28, HSCA sent a letter urging Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander and Ranking Member Patty Murray to pursue legislation to grant FDA the authority to “fast track” Abbreviated New Drug Applications (ANDA) for generic drug manufacturers when the existing generic drug spikes in price. The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in 2012, granted FDA authority to expedite new drug applications if the agency concludes that there is or is likely to be a drug shortage. We are asking the committee leaders to provide FDA the same authority to fast-track approvals for generic drugs experiencing price spikes.

HSCA also sent a letter to the FDA, pressing the agency to make quality metrics available to the public to increase transparency and accountability of drug manufacturers. Premier participated in an FDA public workshop last year and has submitted previous comments asking the agency to regularly publish information on how manufacturers are doing based on standardized quality metrics. Premier believes making information publicly available on which manufacturers reliably produce high quality drugs will help inject competition in the marketplace and prevent future drug shortages by promoting high quality manufacturing practices and thereby mitigating supply delays.