MITIGATING DRUG PRODUCT SHORTAGES

To advocate for ongoing federal evaluation of how drug product shortages present risks to national security and public health; further,

To advocate that drug product manufacturers be required to disclose manufacturing sites and sources of active pharmaceutical ingredients (APIs) to facilitate such a risk assessment; further,

To recommend that the Food and Drug Administration (FDA) require drug product manufacturers to have contingency plans for maintaining drug supplies; further,

To advocate that drug product manufacturers be required to provide a specific reason for a shortage and an estimated timeline for resolution in their Food and Drug Administration Safety and Innovation Act notifications to FDA; further,

To advocate that FDA be required to publicly provide quality ratings for 503B outsourcing facilities preparing copies of drug products under the exemption for products on FDA's shortage list; further,

To advocate that the Federal Trade Commission be required to evaluate the potential for drug product supply chain interruptions when considering manufacturer consolidations.

Rationale

In November 2017, ASHP convened a meeting of healthcare professional organizations to review and identify new opportunities to address the ongoing supply chain and patient care challenges associated with drug product shortages. Participants at the meeting examined how the 2012 FDA Safety and Innovation Act (FDASIA) has impacted drug product shortages and made recommendations to prevent and mitigate future shortages. One of those recommendations was that the federal government undertake an evaluation of the risks drug product shortages could present to national security. Such an evaluation would need to consider the risks posed by sourcing of APIs and excipients, as well as by the location of manufacturing sites.

FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages recommends that drug product purchasers consider quality in making purchasing decisions. Information that purchasers would find helpful in prospectively assessing drug product quality includes the production and compliance history of a manufacturer, the specific name and location of the manufacturing plant, and the source of raw materials. Because approximately 80 percent of APIs used in U.S. drug product manufacturing comes from foreign sources, FDA has limited ability to inspect and certify that those APIs are unadulterated. In addition, although FDA publishes some quality information about manufacturers, it is sometimes difficult to know who the actual manufacturer is and which specific plant location produced the product, because drug companies may rely on contract manufacturers to produce drug products through licensing agreements. Requiring manufacturers to disclose that information publicly would allow for improved evaluation of a manufacturer's integrity and alignment with current good manufacturing processes. Detailed knowledge of manufacturing sites would also allow the government and healthcare systems to plan for or avoid disruptions to the supply chain like those that followed Hurricanes Irma and Maria in 2017, when supplies of 40 critical pharmaceutical products went into shortage, in part because of disruption to the large number of pharmaceutical manufacturing facilities in Puerto Rico. Lack of information about such disruptions can also lead to hoarding, which exacerbates an existing shortage. To avoid similar disruptions, FDA should require manufacturers to have contingency plans for maintaining drug product supplies during events that could disrupt production, such as natural and manmade disasters (e.g., hurricanes, cyber-attacks, electricity failures, shipping disruptions).

FDASIA requires that drug product manufacturers submit a notification of a production disruption to FDA. Manufacturers should also be required to provide in these notices a specific reason for the shortage and an estimated timeline for resolution. This information would be helpful not only to those affected but also in the federal evaluation of the risks posed by drug product shortages. Healthcare providers addressing drug product shortages also need information to evaluate the quality of copies of drug products produced by 503B outsourcing facilities under the exemption for products on FDA's shortage list. Congress should require FDA to publicly provide quality ratings for those manufacturers.

Finally, to avoid future drug product shortages, the Federal Trade Commission should be required to evaluate the potential for drug product supply chain interruptions when considering manufacturer consolidations.