As discussions over the reauthorization of the Generic Drug User Fee Amendments (GDUFA) continue, two professors from MIT and the University of Chicago are calling on Congress to require the Food and Drug Administration (FDA) to be more transparent about the companies that manufacture generic drugs.
The call for more clarity from Rena Conti, assistant professor of Health Policy at The University of Chicago, and Ernst Berndt, a professor of Applied Economics at the MIT Sloan School of Management, comes as the two argued at an FDA GDUFA reauthorization hearing that the number and identity of generic drug manufacturers, particularly in the way that they use contract manufacturing organizations (CMOs), "is shrouded from public oversight," which can be an issue for public health.
More specifically, the professors want FDA to publicize information about the manufacturing facilities and sites for each generic drug, mitigate incentives for companies that use CMOs and consider new incentives to increase the number of generic drug manufacturers to decrease the likelihood of shortages or supply interruptions.
"Only when medical providers know the identity of drug manufacturers can they reassure patients and their families that the supply of essential medicines is meeting the highest quality standards," Conti and Berndt write.
Breakdown of Recommendations
Under the current iteration of GDUFA, FDA collects information on active pharmaceutical ingredients (APIs) and final drug fill and finish (FDFs) manufacturing sites when collecting user fees, including the use and identity of CMOs from Abbreviated New Drug Application (ANDA) sponsors.
"Without imposing additional respondent burden on ANDA sponsors, the FDA could provide a valuable service by making this information public," the professors say, adding that FDA could also make public information about which generics are made by CMOs and at which manufacturing sites, particularly as the use of CMOs more than doubled between 2001 and 2010.
"This database should be available in electronic form and be searchable by drug, formulation, ANDA sponsor, CMO, and production facility location," they claim.
As far as mitigating incentives for generic companies using CMOs, the professors call on Congress to restructure the user fees so that some of the facility fees are shifted to product-specific fees, which they claim could reduce the reliance on CMOs and make the supply of some generics less likely to be disrupted.
"Since the annual user fee is site rather than product-specific, it generates incentives for CMOs to increase the number of products manufactured at their site …the increased fixed costs and scale economies brought about by GDUFA may result in the further outsourcing of manufacturing to CMOs and thereby reduce the number of distinct organizations manufacturing generic specialty and non-specialty drugs, thereby increasing the concentration of manufacturing and making the drug supply chain more vulnerable to supply disruptions," the professors say.
The recommendations from the professors also come as an increasing number of generic drug and active pharmaceutical ingredient (API) manufacturers in recent years, particularly in India, have either been warned by FDA, or have been told to cease sending generic drugs or APIs to the US, which has strained generic supplies.
Back in June, the Generic Pharmaceutical Association (GPhA), the generic industry's top lobbying group, and the Society of Chemical Manufacturers and Affiliates (SOCMA) also raised concerns about the way that GDUFA fees place burdens on smaller generic manufacturers.
Unlike the Medical Device User Fee Agreement (MDUFA), GDUFA does not include provisions guaranteeing reduced fees for small manufacturers or first-time filers.
Industry groups met with FDA last June in an attempt to negotiate a new version of GDUFA before its authorization expires on 30 September 2017. The comment period for the GDUFA public meeting docket, which includes 21 comments from industry and others, was open from 21 April through 15 July, 2015.
Recommendations in Health Affairs