FDA Proposes Ways to Further Address Drug ShortagesBy
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has outlined further steps that the agency is considering to better address drug shortage problems, including improving technology, increasing information-sharing requirements, and requiring risk assessments in companies’ supply chain.
Under the FDA Safety and Innovation Act of 2012, manufacturers are required to notify the FDA of any disruptions, such as manufacturing changes, production or shipping delays, and product discontinuations likely to affect their supply of prescription drugs for serious illnesses. “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 in a May 31, 2018 statement. “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.”
Gottlieb said that the FDA is exploring additional ways that it can encourage companies to voluntarily share more timely information about potential supply disruptions. “We may be able to take new steps to clarify the information the agency requires to inform us better about the extent of a shortage problem,” he said. “We’re also looking at what additional steps we can take, under the existing law, to make the communications we receive more actionable. This includes additional information that can help the FDA develop more effective options for managing a shortage.”
He said that the agency is evaluating its current authorities to see what more it can do to better mitigate and prevent shortages. These measures may include receiving additional, key information from industry when it notifies the agency about a possible shortage and identifying all establishments where manufacturing is performed associated with listed drugs and the type of operation performed at each such establishment. “It’s essential that we evaluate what additional steps we can take to reduce the incidence and impact of shortages, “said Gottlieb in the May 31 statement.
Gottlieb also suggested that the agency may seek additional authority to require risk assessments in supply chains. “It may also require us to work with Congress to re-evaluate our current authorities in these areas,” he said. “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.”
Gottlieb said the agency is now taking steps to bring on new technology that can improve manufacturing to mitigate supply disruptions. “The FDA has 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,” said Gottlieb in the May 31 statement, pointing to continuous manufacturing as one such example.
Gottlieb further highlighted the ways in which the agency now addresses drug shortages. These include expediting facility inspections and drug-application assessments so that a facility can become operational as soon as possible to provide a given drug. The agency 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. The FDA also alerts other manufacturers of similar or alternative products to consider increasing production to meet an anticipated increased demand for their product. In cases where alternative manufacturing is not available in the US or the manufacturers of US-marketed products are not able to expand production, the agency may explore importation of a product from a foreign manufacturing source until the shortage is resolved.