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FDA Needs Industry Cooperation to Mitigate Shortages

Will companies eventually be required to conduct a risk assessment to identify the vulnerabilities in their drug supply?

Quite often, hospitals and health care facilities are blindsided by drug shortages. FDA notes that only 2% of shortages are due to discontinuation, meaning that the overwhelming majority of shortages are supply chain disruptions to actively marketed products.

The health outcomes in drug shortage situations can be dire. In a recent statement from FDA Commissioner Scott Gottlieb, FDA also identified the significant costs associated with drug shortages and urged manufacturers to communicate with them, as the agency looks at new steps to prevent supply chain shortages.

“Among these interruptions, manufacturing and quality issues are the leading causes of drug shortages. This includes outdated equipment in need of repair or replacement, unexpected issues with a product’s composition, and a manufacturer’s inability to maintain facility and product quality,” said Gottlieb. “The availability of raw materials can also be a key factor in creating supply disruptions. A disruption from one supplier of raw materials can affect production for many drug makers that all depend on that one source of raw material. Companies that supply raw materials can also be subject to quality problems, leading to shortages.”

The release cited a few specific examples:

  • Companies that make competing products merge, and discontinue one of the competing products.

  • Manufacturers make production decisions based on business considerations, such as a product’s profitability, manufacturing costs, distribution quotas and patent life.

  • Aside from production issues and decisions, Gottlieb noted “an unforeseen increase in clinical demand, changes in clinical practice guidelines, or even FDA approval of a new indication for an existing drug, can all lead to an unexpected surge in demand for a particular medicine. The increased demand can, in turn, lead to a shortage of that specific drug.”

One issue with shortages is that they often affect “low-profit generic medications, for which the investment needed to ensure continued production can be less than that for higher profit products.”

Expanding FDA authority?

The statement noted that “one consideration might be to expand the FDA’s existing authority to require applicants of certain drugs to conduct a risk assessment to identify the vulnerabilities in their drug supply, including vulnerabilities that could cause a shortage, and establish risk mitigation plans to address those risks.”

Industry cooperation

Gottlieb cited the need for working more closely with sponsors to help prevent or minimize disruptions in advance, which starts with sponsors alerting the FDA to potential issues. While FDASIA “generally requires” manufacturers to notify the agency of manufacturing changes, production or shipping delays, and product discontinuations, more can be done.

“These notification requirements are critical, but there are many times manufacturers abruptly discontinue, limit, or delay production under circumstances outside those for which they are specifically required to provide advance notice to the agency,” said Gottlieb. “There are other times when companies notify the FDA of potential supply disruptions, but don’t provide enough details to allow us to make the fullest use of our resources to address the shortage. We need to know as much as possible about these shortages.”

The more information manufacturers provide, the better. The FDA is exploring additional ways to encourage companies to voluntarily share more timely information about potential supply disruptions, including the potential for:

  • Clarifying the information the agency requires in advance

  • Making communication more actionable

Gottlieb also cited, in some cases, that the resolution may involve companies seeking approval for new drugs in short supply. “When that opportunity arises, we do what we can to prioritize these circumstances. For example, if a new production facility or supplier is needed, we have the regulatory authority to expedite facility inspections and drug application assessments so that the facility can become operational as soon as possible. We can also expedite review of a new or generic drug application that, if approved, may serve as an alternative therapy to a product facing a shortage. Even when a shortage situation is urgent, patient safety remains our top priority. We make sure that any approvals of such alternate therapies meet our standards.”

The FDA has also implemented an emerging technology program and established an emerging technology team to engage with companies about new production technologies that could, in the long run, prevent drug shortages caused by product quality and manufacturing problems, such as continuous manufacturing.

Read the full statement here.

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