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New FDA guidance clarifies which drugs require risk management plans – Endpoints News

As the majority of drug shortages are still associated with quality issues related to manufacturing, the FDA on Thursday released new orientation project explaining how to proactively assess risks to manufacturing processes and supply chains, while understanding market vulnerabilities.

While drug shortages peaked in 2011, the FDA says in its new 18-page draft guidance that the number of new drug shortages “has declined significantly since” that peak, bottoming out in 2015 and 2016, in part. through the enactment of a new law. , known as FDASIA, which helped the agency better prevent or mitigate drug supply disruptions and shortages, and clarified cGMP requirements.

However, the FDA explains how this downward trend “did not continue in subsequent years”, noting:

Drug shortages continue to occur and at approximately the same levels since 2018. Additionally, drug shortages have become more persistent (i.e., the duration of active drug shortages is getting longer). Many reasons for drug shortages are, for example, problems with drug quality, disruptions in supply chain manufacturing operations (for example, caused by a natural disaster or discontinuation of components by suppliers), limitations in forecasting future demand and product drug market withdrawals.

In March 2020, with the promulgation of the CARES ActCongress added a section to the law governing the FDA, which took effect in September 2020, that requires certain manufacturers to develop, maintain, and implement a “redundancy risk management plan that identifies and assesses risks for the supply of the drug, as applicable, for each establishment in which such drug or active pharmaceutical ingredient of such drug is manufactured.

Since at least the publication of ICH Q9 in 2006, the pharmaceutical industry has taken steps to implement quality risk management principles.

The types of drugs for which the FDA will require risk management plans include:

  • Essential and Life-Essential Drugs and APIs
  • Drugs to prevent or treat a disease or debilitating condition, including for emergency medical care or surgery or which are essential to public health during a public health emergency
  • Any associated medical device used for the preparation or administration of these drugs

For 7 other drug types, the FDA draft says it recommends, rather than requires, RMPs:

  1. Drugs to treat rare diseases
  2. Drugs that lack suitable alternatives
  3. Medical countermeasures used in the event of a potential public health emergency resulting from a terrorist attack with biological, chemical or radiological/nuclear material, or naturally emerging disease and other threatening agents (i.e. essential to national security)
  4. Single-source drugs
  5. Drugs with a single API manufacturer in the product supply chain that has been appropriately qualified by the finished dosage form (FDF) establishment’s quality unit
  6. Medicines with a single FDF manufacturer in the product supply chain
  7. Drugs manufactured at a facility (including packaging facilities and laboratories) with an inspection within the past 5 years that has been classified as an Official Action Indicated (OAI) and there is no other manufacturing facility that is qualified in the product supply chain to perform this operation

While the agency recognizes that shortages and shortage mitigation efforts represent a significant financial and resource burden on pharmaceutical companies, among other stakeholders, the FDA said it views RMPs as an important mechanism to proactively identify, assess and mitigate risks that could lead to disruption of drug supply.

Additionally, in recent years, the FDA said it has observed an increase in the number of cyberattacks against drugmakers “and is increasingly concerned about the effect of these attacks on the drug supply chain.”

In 2017, a cyberattack involving ransomware on Merck’s manufacturing operations led to issues that lasted more than a month after the attack.


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