190111 aha fda request for comments on public meeting dentifying root causes of drug shortages and finding enduring solutions

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1 January 11 , 2019 Scott Gottlieb, M. D. Commissioner Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 -2018- Re: Docket No. FDA N-3272, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions; Public Meeting; Request for Comments; Federal Register (Vol. 83, No. 175), September 10, 2018. Dear Commissioner Gottlieb: On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, and our clinician partners – including more than 270,000 affiliated physicians, 2 million nurses and other caregivers – and the 43,000 health care leaders who belong to our professional membership groups, the American Hospital Association provide feedback on the (AHA) appreciates the opportunity to Food and Drug Administra tion’s (FDA) request for comments on the public meeting, “ Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions .” New and chronic shortages of critical drugs are among the biggest challenges facing patients and . They threaten the quality of patient care, affect treatment hospitals ess options, and often require the use of alternative products that may be l /effective for the patient and/or less familiar to clinical staff, which can appropriate for medical er rors. Drug shortages also increase costs to increase the potential hospitals and health care systems by, for example, diverting staff away from direct patient care in order to manage shortages, by substituting more expensive drugs or therapies for the shortage drugs by requiring adjustments to the management and , and documentation of the electronic health record (EHR) . Moreover, drug shortages pose a threat to the public’s health and to national security by decreasing the preparedness and resilience of health care systems and com munities for public health emergencies. To that end, the AHA conducted extensive policy work on this issue and includes below our key legislative, regulatory and best practices recommendations derived from these discussions.

2 Scott Gottlieb, M .D. 11, 2019 January 7 Page 2 of ACKGROUND B on the drug shortages issue engaged The AHA has been actively since 2010, when the numbers of new shortages began to skyrocket. We have a close working relationship FDA’s drug shortage staff , whose actions with successfully prevent ed, the have ed and resolv ed many drug shortages over the years . In particular, FDA’s efforts mitigat have led to a significant decline in the number of new shortages since 2010. However, ing we have seen a troubl persistent shortages in recent increase in the number of years , such as for intravenous (IV) saline and other generic sterile injectable . Thus , the serious issues underlying drug shortages remain, may be medications and getting worse. Steps need to be taken to ensure that the right drugs are available to patients at the right time. the FDA’s leadership in address ing critical drug shortages , including the We applaud the creation of a Drug Shortage Task Force, prioritization of Abbreviated New Drug Applications (ANDAs) for drugs where there are fewer than three generic alternatives , improved regulatory harmonization across global supply chains to facilitate the expedited importation alternatives, and a reduction in the backlog of new ANDAs. We also appreciate the opportunities FDA has provided for hospitals and other stakeholders their perspectiv to share to address this daunting es and policy recommendations challenge, including convening listening sessions and holding the Nov . 27, 2018 public meeting. The AHA looks forward to continuing to work with the FDA on this challenging issue . The AHA is Together a co- convening member of the National Drug Shortage Summit. core members of the Summit – the e other System with th American Society of Health- Pharmacists (ASHP), the American Society of Clinical Oncologists, the American Society of Anesthesiologists and the Institute for Safe Medication Practices , we have worked n the Executive Branch and to raise the profile of drugs shortages withi Congress. several workshops , most recently a Sept. 20, 2018 The Summit has held meeting focused on the national s ecurity implica tions of drug shortages. In addition, t he AHA helped plan a Sept. 5 -6, 2018 workshop , “Medical Product Shortages During Disasters: Opportunities to Predict, Prevent, and Respond, ” convened by the National emies of Sciences, Engineering, and Health & Acad Medicine, at the request of the Human Services Office of the Assistant Secretary for P reparedness and Response. Also, AHA joined a drug shortage working group o rganized by the Health last spring the Supply Chain Association to develop recommendations and policy proposals to help prevent and address drug shortages. we survey ed AHA members to assess shortages and how they have impacted Finally, patient care and hospital operations. Most recently, the AHA, in collaboration with the Federation of America’s Hospitals, conducted a study and will be releasing an independent report by the NORC at the University of Chicago in mid- January that details the specific experience of hospitals and health systems wi th drug purchasing

3 Scott Gottlieb, M .D. 11, 2019 January 7 Page 3 of and drug shortages. , we will share Whi for this docket le outside of the comment period the work of the Drug the report when it is available, as the data may help inform Task Force. Shortages R EGISLATIVE L ECOMMENDATIONS manufacturers’ Strengthen shortage disclosure requirements . Title X of the FDA drug , enacted in 2012, requires Safety and Innovation Act (FDASIA) drug manufacturers to notify “of any change in production that is reasonably likely to lead to reduction in FDA of a covered drug in the U.S., but does not require disclosure of the reason for supply,” a halt in production or an expected timeline to address it. Further, the only consequence for failing to comply with the drug shortage notification requirement is public discl osure of the failure by FDA . While t reporting requirement has helped the FDA to reduc e his , more must be done. the number of drug shortages drug The AHA recommends that Congress strengthen the current manufacturer reporting requirements to inclu de disclosure of the problem that is shortage manufacturing interruption, the extent of the shortage, and the causing the expected duration of the shortage. Failure to provide timely notice of an interruption should result in a monetary penalty for the manufacturer. In addition, manufacturers should be required to report current or anticipated supply acquisition of raw materials. concerns, including issues pertaining to the production or The information provided should be easily accessible by the public on the FDA’s allow FDA and providers to better prevent and . Such enhanced reporting would website shortages. manage manufacturing contingency plans and/or redundancies . Drug shortages can Incentivize however have negative impacts on patient safety and access to care; , drug Congress should manufacturers cannot always predict when a shortage will occur. enact incentives for drug manufacturers to establish contingency plans and/or redundant production lines to be used in the event of a shortage, specifically for These plans drugs that have fewer than three manufacturers. should include prioritizing the most medically necessary products, qualifying third -party suppliers across their network, and increasing production and inventory for raw materials and finished goods. production transparency requirements . Congress should require Enhance manufacturers to disclose to the FDA the location of production, including situations where a contract manufacturer is used. Further, there may be situations, such as when a natural disaster is i mminent (e.g. , Hurricane Maria in Puerto Rico ), in which the should release information simult aneously to the entire drug supply FDA chain, including health care providers, about which drugs are produced at impacted locations so as to allow providers and others to engage in advance planning. To prevent

4 Scott Gottlieb, M .D. 11, 2019 January 7 Page 4 of hoarding of inventory that could result from such communication, manufacturers could s on an allocation list to ensure that the remaining supply is distributed put product equitably. This information is critical to ensure that all stakeholders take the most effective steps toward addressing drug shortages and ensuring uninterrupted, quality care for patients. Enact shortage disclosure notification requirements for certain medical devices needed to administer drugs . Congress should enact legislation that requires medical device manufacturers to notify FDA in the event of an interruption or discontinuation for certain medical devices and equipment needed to administer drugs containers needed to (e.g., for infusion ), similar to the 2012 FDASIA notification requirement for drug dilute drugs IV manufacturers . Assess drug shortages as a national security threat . Require federal agencies with jurisdiction over national security to conduct an analysis of domestic drug and medical device manufacturing capability and capacity for critical products to assess whether a threat to national security exists. Include potential risk for drug shortages as a factor in the Federal Trade Commiss ion (FTC) review s of drug company merger proposals . Congress should request the FTC consider the potential risk for drug shortages when reviewing drug company mergers and acquisitions. R ECOMMENDATIONS EGULATORY R incentives to encourage manufacturers to produce drugs in shortage. When a Establish drug is in shortage, it is often difficult to find a manufacturer willing to increase or begin the FDA should explore additional incentives to production of the drug. Therefore, in shortage . encourage other manufactures to begin producing drugs that are Prevent manufacturing shutdowns . The FDA should improve the process for enforcing the current good manufacturing practices (cGMP) regulations by shortening turnaround times and improving and standardizing processes of FDA oblems prior to shutting down facilities. Further, a m ore rapid reviews to identify pr review of corrective actions taken by manufacturers could help reduc e the duration of supply interruptions . Establish a quality manufacturing initiative. The FDA should establish a manufacturing rating system where higher quality manufacturing receives the The FDA should consider incentives for manufacturers to participate in higher rating. the program. The rating system should include factors such as whether the company has a contin gency plan for production interruptions and disasters and whether the company has a plan for redundancy in production.

5 Scott Gottlieb, M .D. 11, 2019 January 7 Page 5 of Enhance information on the quality of outsourcing facilities’ compounding. Although outsourcing facilities registered with the FDA under section 503B are able to compound drugs that are in shortage, it is difficult for pharmacies to evaluate the quality of a 503B facility. This is especially true for an outsourcing facility that has been issued an FDA FDA should Form 483, indicating that the company has a problem with quality. and remove the 483 in disclose more information regarding why a 483 was issued issue when the a timely way has been resolved. mprove the FDA Expand and i ist . The FDA’s drug shortage list does ’s drug shortages l not take into account drugs that are in shortage based on their administration form and dosage, and does not include drugs that are experiencing significant regional shortages. the FDA should expand its list of drug shortages to incorporate drugs Therefore, It also should included on the ASHP’s more comprehensive drug shortage list. , such as include additional information that would be helpful to mitigate shortages information on 503B compounders. This would help ensure that the drug shortages list is comprehensive, current and better able to be used to appropriately prioritize efforts to resolve shortages. a list of critical Develop . The FDA should use the World Health drugs Organization’s Model Lists of Essential Medicines and other existing resources to develop a list of critical drugs needed for emergency response and for saving and preserving The critical drug list coul d be used for a variety of purposes, life. stabiliz the supply of critical drugs by working with manufacturers and including for: ing FDA to create redundant product in multiple locations in anticipation of natural the threats the quality of pharmaceutical disasters and other supply chain ; assessing list ; and manufacturers measured against the importance of drugs on the critical ing great er transparency surrounding the sources of these drugs’ raw materials provid and manufacturing locations so providers can more easily assess pharmaceutical product quality. 1 on the market might impact “unapproved” Consider how reducing the number of drugs . The FDA has been assisting drug manufacturers shortages with finding opportunities to legally market older “grandfathered” products that are currently marketed without the required FDA approval. While the FDA approval process ensures that marketed drugs meet current FDA standards for safety, efficacy, quality and labeling, there have been concerns that these efforts to bring widely used but unapproved drugs into compliance with current FDA requirements have resulted in drug shortages. Before efforts to bri ng unapproved drugs into compliance are started, FDA should carefully balance the benefits of approval with the possibility that this process could result in shortages of these older, but often essential, drugs . 1 Pre -1938 drugs marketed prior to the enactment of the Food, Drug and Cosmetics Act.

6 Scott Gottlieb, M .D. 11, 2019 January 7 Page 6 of ze manufacturers to market The FDA should i Reduce drug waste. ncentivi repackaged sterile injectable drugs in the dosages commonly used in clinical . care to reduce waste Create an Office of Clinical Affairs within the Drug Enforcement Administration (DEA) . Such an office would help ensure that DEA personnel are available to address the , thereby better balancing the clinical implications of shortages of controlled substances control and enforcement. agency’s current focus only on diversion ARKET R ECOMMENDATIONS M early Encourage shortage alerts and m ulti- stakeholder c ommunications . All drug stakeholders in the market, including providers, manufacturers, wholesalers, group purchasing organizations and others should communicate with the FDA as soon as a potential shortage situation is identified, and continue to share information as available . FDA and others should continue working to improve inter - -agency coordination in shortage situations like the agency communication and cross in 2018, which required invol injectable narcotic shortage that occurred vement of both Encouraging early and ongoing communication is critical for the FDA and the DEA. mitigating risk and reducing the likelihood of shortage situations. drug shortage action plans . Drug m anufacturers should develop shortage Develop action plans that would help prevent, identify and actively respond to drug shortage situations if they arise. These remediation plans should be updated annually . Establish best practices for critical Best practices should be established for drugs . be helpful in the This not only will utilizing certain widely used and critical drugs. event of a shortage, but if widely applied, also th care will reduce waste throughout heal system s, thus helping to prevent shortage situations. Focus specifically should be pla fluid waste. Once best practices are established, a multidisciplinary ced on limiting IV educational component should be implemented ensuring that all medical professionals . are trained and educated in these best practices Encourage EHR vendors to make changes to their systems to ease the burden of making drug product changes ed automation in hospitals and other health . While increas care settings has improved patient safety and created efficiencies, these systems are often designed to use a certain product. When a shortage occurs it often takes countless hours and staff time to make a change to the EHR system to reflect the use of oduct EHR vendors should make changes to their systems to an alternative pr . make it easier to switch products. example would be a tool that makes changes to An various integrated technology databases at the same time (like EHR and smart pump drug libraries, or automated dispensing cabinets and pharmacy inventory systems).

7 Scott Gottlieb, M .D. 11, 2019 January 7 of 7 Page We appreciate the opportunity to provide feedback look forward to continuing to and work with the FDA on finding enduring solutions to drug shortages. Please contact me if you have questions about our comments or feel free to have a member of your team contact Roslyne Schulman, director of policy, at 202- 626- 2273 or [email protected] . Sincerely, /s/ Thomas P. Nickels Executive Vice President Gover nment Relations and Public Policy

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