Drug Shortages: FDA Wants Ideas To Boost Manufacturing Quality For Strategic Plan
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency asks for comments to help it formulate a strategic plan to mitigate and prevent drug shortages, including ideas for incentives to increase manufacturing capacity and promote increased quality.
A new FDA strategic plan to deal with drug shortages may focus on incentivizing manufacturing quality, an issue the agency has argued is among the primary causes of the problem.
The agency is seeking public comments on several shortage issues to help an internal task force formulate the plan, which is mandated by the FDA Safety and Innovation Act. The final document is expected to focus on drug and biologic shortages, the agency said in a Federal Register notice expected to be published Feb. 12.
FDASIA also requires manufacturers to give FDA advance notice of a production interruption or stoppage to improve shortage prevention and mitigation efforts (Also see "FDASIA Is Signed, Not That White House Wanted Anyone To Notice" - Pink Sheet, 16 Jul, 2012.).
FDA wants new ideas to promote “high-quality manufacturing” as well as encourage more growth of production capacity, according to the notice.
Agency officials are looking for comments on the types of metrics used to monitor manufacturing quality, as well as the measurements available to purchasers and prescribers that could help determine where to acquire various products and chose a contract manufacturer.
FDA also wants to know the extent quality measures are used in making purchasing decisions and at what frequency they should be updated in order to be meaningful, according to the notice.
The focus on improving quality follows FDA’s argument that manufacturing problems are among the causes for a number of drug shortages, including those in the sterile injectable market (Also see "FDA And Generic Drug Quality: Turning Point, Or Precipice?" - Pink Sheet, 8 Oct, 2012.).
Center for Drug Evaluation and Research Director Janet Woodcock and Director of Analysis Staff Marta Wosinska argued in a recent journal article that sterile injectable buyers and payers share some responsibility for shortages because the market does not reward quality manufacturing.
That forces price-based competition, which encourages less quality investment (Also see "Drug Shortages: FDA Says Market Must Reward Production Quality" - Pink Sheet, 28 Jan, 2013.).
House members already have blamed a recent FDA focus on enforcement as the cause of several shortages (Also see "Drug Shortages Mostly FDA’s Fault, House Oversight Committee Concludes" - Pink Sheet, 15 Jun, 2012.).
Ideas To Increase Manufacturing Capacity Needed
The shortage strategic plan also could include ideas to increase manufacturing capacity.
FDA asked for ideas about incentives “to encourage manufacturers to establish and maintain high-quality manufacturing practices,” including operational redundancy and capacity expansion. The agency also wants ideas for incentives that could be offered in conjunction with other government agencies.
FDA asked in the notice whether “a qualified manufacturing partner program” could be designed that would “have a positive impact on shortages.”
The agency cited the Biomedical Advanced Research and Development Authority’s qualified manufacturing partner program as a potential model. BARDA works with manufacturers to create vaccines and other drugs that could be used in the event of a public health emergency.
Novartis AG recently partnered with BARDA to develop the technology used to manufacture its influenza vaccine Flucelvax (Also see "Novartis’ Cell-based Vaccine: Seasonal Approval With Pandemic Implications" - Pink Sheet, 21 Nov, 2012.).
FDA said in the notice it cannot recreate the BARDA program, however, because there is no consistent or predictable list of drugs at risk of a shortage or money for market-making activities.
“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,” the agency said in the notice.
Increasing the Medicare reimbursement rates for drugs prone to shortages also has been suggested to help attract more companies to the sterile injectables market (Also see "Medicare Reimbursement Rate Targeted As Culprit For Drug Shortages" - Pink Sheet, 30 Nov, 2011.).
Communication, Regulatory Flexibility Improvements Possible?
FDA also wants ideas to improve its existing shortage communication and management methods, including its regulatory flexibility.
Agency officials asked whether its enforcement discretion and policy of expediting the review of regulatory submissions could be improved or whether new tools should be added.
FDA encourages other manufacturers to increase production or can import unapproved alternatives temporarily to relieve a shortage (Also see "Doxil Shortage Solution: FDA Chooses Middle Ground, Allows Import Of Unapproved Version" - Pink Sheet, 19 Mar, 2012.).
In addition, the agency is seeking ideas for alternative or improved shortage communications to help health care professionals, manufacturers, distributors and patients and what it can do to mitigate shortage impacts on research and clinical trials, it said in the notice.
Comments are due to the docket by mid-March.