February 27, 2013 FDA Strategic Plan to Address Drug Shortages, Solicitation for Comment - See more at: http://www.policymed.com/2013/02/fda-strategic-plan-to-address-drug-shortages-solicitation-for-comment.html#sthash.RZdGQEmp.dpuf

Earlier this month, the Food and Drug Administration (FDA) released a notice for public comment in the Federal Register regarding ideas stakeholders and the public may have for combating drug shortages.  As noted on FDA’s own blog, the agency believes that despite the progress made over the last year, even more can be done and is therefore turning to the American public for advice. 

Comments due by Thursday, March 14, 2013.  The Docket Number is FDA-2013-N-0124. 

Background 

As we previously wrote this summer, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) on July 9, 2012.  Section 1003 of FDASIA adds section 506D to the Federal Food, Drug, and Cosmetic Act (the FDCA) to require the formation of a task force to develop and implement a strategic plan for enhancing the Agency's response to preventing and mitigating drug shortages.  Section 506D of the

FDCA (21 U.S.C. 356) requires that the drug shortages strategic plan include the following:

• Plans for enhanced interagency and intra-agency coordination, communication, and decisionmaking;
• Plans for ensuring that drug shortages are considered when the Secretary initiates a regulatory action that could precipitate a drug shortage or exacerbate an existing drug shortage;
• Plans for effective communication with outside stakeholders, including who the Secretary should alert about potential or actual drug shortages, how the communication should occur, and what types of information should be shared;
• Plans for considering the impact of drug shortages on research and clinical trials; and
• An examination of whether to establish a “qualified manufacturing partner program” as described in section 506D(a)(1)(C) of the FD&C Act. 

Per the directive in section 506D, FDA has formed an internal Drug Shortages Task Force (Task Force) to develop and implement the drug shortages strategic plan.  The Task Force is seeking comments from the public on issues related to the development of this strategic plan.  Importantly, although FDASIA refers only to a drug shortages strategic plan, FDA anticipates that the strategic plan will consider prevention and mitigation of both drug and biological product shortages.  Accordingly, FDA expressed its interest in receiving comments on the following questions from all parties, including those with an interest in biological products: 

1. In an effort to address the major underlying causes of drug and biological product shortages, FDA is seeking new ideas to encourage high-quality manufacturing and to facilitate expansion of manufacturing capacity. 
2. To assist in the evaluation of product manufacturing quality, FDA is exploring the broader use of manufacturing quality metrics.  With that in mind, FDA would like input on the following issues:  What metrics do manufacturers currently use to monitor production quality?  To what extent do purchasers and prescribers use information about manufacturing quality when deciding how to purchase or utilize products? What kinds of manufacturing quality metrics might be valuable for purchasers and prescribers when determining which manufacturers to purchase from or which manufacturers' products to prescribe? What kinds of manufacturing quality metrics might be valuable for manufacturers when choosing a contract manufacturer? How frequently would such metrics need to be updated to be meaningful. 
3. The use of a qualified manufacturing partner program similar to one used under the Biomedical Advanced Research and Development Authority (BARDA) has been suggested as a potentially useful approach to expanding manufacturing capacity and preventing shortages. FDA recognizes that there are important potential differences between the BARDA program and the use of a parallel program to address shortages. For example, the BARDA program covers a relatively stable and limited number of products, but drugs at risk of shortage are many, may change rapidly over time, and are difficult to predict in advance. In addition, FDA does not have funding to pay manufacturers to participate in a drug shortages qualified manufacturing partner program or to guarantee purchase of the end product. With these differences in mind, is it possible to design a qualified manufacturing partner program that would have a positive impact on shortages? 
4. Are there incentives that FDA can provide to encourage manufacturers to establish and maintain high-quality manufacturing practices, to develop redundancy in manufacturing operations, to expand capacity, and/or to create other conditions to prevent or mitigate shortages? 
5. In FDA’s work to prevent shortages of drugs and biological products, FDA regularly engages with other U.S. Government Agencies.  Are there incentives these Agencies can provide, separately or in partnership with FDA, to prevent shortages? 
6. When notified of a potential or actual drug or biological product shortage, FDA may take certain actions to mitigate the impact of the shortage, including expediting review of regulatory submissions, expediting inspections, exercising enforcement discretion, identifying alternative manufacturing sources, extending expiration dates based on stability data, and working with the manufacturer to resolve the underlying cause of the shortage. Are there changes to these existing tools that FDA can make to improve their utility in managing shortages? Are there other actions that FDA can take under its existing authority to address impending shortages? 
7. To manage communications to help alleviate potential or actual shortages, FDA uses a variety of tools, including posting information on our public shortages Web sites and sending targeted notifications to specialty groups. Are there other communication tools that FDA should use or additional information the Agency should share to help health care professionals, manufacturers, distributors, patients, and others manage shortages more effectively? Are there changes to FDA’s public shortage Web sites that would help enhance their utility for patients, prescribers, and others in managing shortages? 
8. What impact do drug and biological product shortages have on research and clinical trials? What actions can FDA take to mitigate any negative impact of shortages on research and clinical trials? 
9. What other actions or activities should FDA consider including in the strategic plan to help prevent or mitigate shortages? 

Other Drug Shortage News 

In addition, FDA recently announced the approval of the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).  Doxil is currently on FDA’s drug shortage list.  The generic is made by Sun Pharma Global FZE (Sun).  Doxorubicin hydrochloride liposome injection is administered intravenously by a health care professional. Sun’s generic will be available in 20 milligram and 50 milligram vials. 

- See more at: http://www.policymed.com/2013/02/fda-strategic-plan-to-address-drug-shortages-solicitation-for-comment.html#sthash.RZdGQEmp.dpuf