

Comment Info: =================

General Comment:We share FDA?s concern about the public health impact caused by drug shortages and strive to meet our corporate mission of serving every patient, every time.  We fully support efforts to develop effective means to address the causes of these shortages and to minimize their impact and duration when they do occur.  For example, we have spent hundreds of millions of dollars in the past several years to minimize the risk of shortages of our drug products.  These actions include: 1) continued emphasis on GMP compliance; 2) Investments in new technology to optimize our control over processes and to minimize the possibility of contamination and cross-contamination; 3) maintenance  of inventory levels commensurate with the risk of market demand fluctuation and potential natural disasters,  and 4) ensuring redundant manufacturing capability for our products.  

Having patients and their families worry about the availability of appropriate drugs to treat life threatening conditions is an unnecessary and avoidable burden in addition to the anxiety caused by the medical condition itself.  

Amgen supports FDA?s efforts to require advance notification of situations and events that may result in drug shortages, of innovative and generic drugs alike.  Advance notification has clearly allowed FDA to work with all stakeholders and exercise regulatory flexibility to prevent and minimize the impact of drug shortages.  We also support FDA?s proposal to review NDA/BLA supplements, and conduct pre-approval inspections where necessary, on an expedited basis.  We applaud FDA?s efforts to strongly encourage advance notification for biological products, including recombinant therapeutic drugs and monoclonal antibodies, because these innovator and biosimilar products include many life-saving and life- sustaining products.

(To read more, please see attached letter)
