While discussions on the reuse of generic changes Drug User Fee (GDUFA) will continue, both professors at MIT and the University of Chicago are asking Congress to require the Food and Drug Administration (FDA) to be more transparent about companies that manufacture generic drugs.
The call for greater clarity Rena Conti, assistant health policy at the University of Chicago professor, and Ernst Berndt, professor of Applied Economics at the Sloan School of Management at MIT, comes as both have argued during a hearing the FDA reauthorization GDUFA the number and identity of generic manufacturers, particularly in the way they use manufacturing organizations (CMO) contract ", is wrapped in the public control", which can be a problem for public health.
Specifically, teachers want FDA to disseminate information on the manufacture and site facilities each generic drug, reduce incentives for companies that use the new CMO and incentives to increase the number of generic companies to reduce the likelihood shortages or supply disruptions.
"Only when doctors know the identity of the drug manufacturers can reassure patients and their families as the provision of essential drugs is meeting high standards of quality," Conti Berndt and writing.
The call for greater clarity Rena Conti, assistant health policy at the University of Chicago professor, and Ernst Berndt, professor of Applied Economics at the Sloan School of Management at MIT, comes as both have argued during a hearing the FDA reauthorization GDUFA the number and identity of generic manufacturers, particularly in the way they use manufacturing organizations (CMO) contract ", is wrapped in the public control", which can be a problem for public health.
Specifically, teachers want FDA to disseminate information on the manufacture and site facilities each generic drug, reduce incentives for companies that use the new CMO and incentives to increase the number of generic companies to reduce the likelihood shortages or supply disruptions.
"Only when doctors know the identity of the drug manufacturers can reassure patients and their families as the provision of essential drugs is meeting high standards of quality," Conti Berndt and writing.
Breakdown of Recommendations
In the current version of GDUFA, FDA collects information about pharmaceutical active ingredients (API) and final drug filling and finishing (fdfs) production facilities in the collection of user fees, including the use and the identity of the sponsors (ANDA) CMO abbreviated new drug application.
"Without the imposition of the burden of additional response sponsors ANDA, FDA could provide a valuable service to the public with this information," say the teachers, adding that the FDA may also make public the information on which generic drugs are manufactured by OCM and the manufacturing sites, in particular the use of the CMO has more than doubled between 2001 and 2010.
"This database should be available in electronic format and can be searched by the drug, formulation, sponsor of ANDA, CMO, and location of production facilities," they say.
As for mitigation incentives for generic companies using OCM, teachers called on Congress to restructure user fees so that some facilities rates move to own fresh produce, which they claim could reduce dependence on the CMO and make the supply of certain generic drugs are less likely to be disturbed.
"From the annual user fee is the site rather than specific products generates incentives for the OCM to increase the number of products made on their website ... the increase in fixed costs and economies of scale induced GDUFA You can lead the continued outsourcing OCM manufacturing and reduce the number of generic specialty manufacturing and non-specialized drugs, increasing the concentration of production and make the supply chain more vulnerable drug supply disruptions organizations separate, "the teachers say.
The teacher recommendations also come as an increasing number of generic drugs and active pharmaceutical ingredients (API) manufacturers in recent years, particularly in India, they should be notified by the FDA, or they have said stop sending drugs or generic API in the United States, which weighed about generic supplies.
"Without the imposition of the burden of additional response sponsors ANDA, FDA could provide a valuable service to the public with this information," say the teachers, adding that the FDA may also make public the information on which generic drugs are manufactured by OCM and the manufacturing sites, in particular the use of the CMO has more than doubled between 2001 and 2010.
"This database should be available in electronic format and can be searched by the drug, formulation, sponsor of ANDA, CMO, and location of production facilities," they say.
As for mitigation incentives for generic companies using OCM, teachers called on Congress to restructure user fees so that some facilities rates move to own fresh produce, which they claim could reduce dependence on the CMO and make the supply of certain generic drugs are less likely to be disturbed.
"From the annual user fee is the site rather than specific products generates incentives for the OCM to increase the number of products made on their website ... the increase in fixed costs and economies of scale induced GDUFA You can lead the continued outsourcing OCM manufacturing and reduce the number of generic specialty manufacturing and non-specialized drugs, increasing the concentration of production and make the supply chain more vulnerable drug supply disruptions organizations separate, "the teachers say.
The teacher recommendations also come as an increasing number of generic drugs and active pharmaceutical ingredients (API) manufacturers in recent years, particularly in India, they should be notified by the FDA, or they have said stop sending drugs or generic API in the United States, which weighed about generic supplies.
Negotiations
Concerns In June, the Generic Pharmaceutical Association (GPhA), upper lobby of the generic industry, and the Society of Chemical Manufacturers and Affiliates Products (SOCMA) has also raised about how fees GDUFA place burdens for smaller generic companies size.
Unlike Agreement rates for medical devices (MDUFA) GDUFA not include provisions guaranteeing reduced for small manufacturers and journalists for the first time types.
Industry groups have met with the FDA last June in an attempt to negotiate a new version of GDUFA before his authorization expires on September 30, 2017. The comment period for the public meeting GDUFA record, which includes 21 comments industry and others, was open from 21 April to 15 July 2015.
Unlike Agreement rates for medical devices (MDUFA) GDUFA not include provisions guaranteeing reduced for small manufacturers and journalists for the first time types.
Industry groups have met with the FDA last June in an attempt to negotiate a new version of GDUFA before his authorization expires on September 30, 2017. The comment period for the public meeting GDUFA record, which includes 21 comments industry and others, was open from 21 April to 15 July 2015.
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