Increasing Transparency in Drug/Medical Device Manufacturers

The National Academies of Science, Engineering and Medicine (NASEM) has published a report on resiliency in the medical supply chain that calls for the US Food and Drug Administration (FDA) to publicly disclose the location of all manufacturing facilities that supply ingredients and parts for pharmaceuticals and medical devices approved in the US.

The report recommends FDA publicly disclose information on drug sourcing, manufacturing quality and volume, and capacity for medical products approved for sale in the US.
 
“The manufacturer for a pharmaceutical drug should be required to publicly disclose the manufacturing location, in particular the FDA Establishment Identifier (FEI), the city, and the country for the finished dosage form (FDF), active pharmaceutical ingredient (API, major excipients, and major packaging and delivery devices for all pharmaceutical drugs sold in the United States,” said a report summary.
 
The same recommendation also applies to devices; device manufacturers should publicly disclose the manufacturing location in the FEI, the city, and the country involved in the device’s manufacturing and final assembly.
 
The report also recommends FDA make its risk-based site selection model scores publicly available. Wow, not only would that be good for consumers, I’d love to know where my sites fall in on that scoring.

Hurry up and put this recommendation in place!

Transparency is a good thing and it is shown to increase consumer safety. It is a problem that even a fairly knowledgeable industry professional like myself cannot figure out where generics are manufactured without making a few phone calls and shaking down my friend network. And even then, I’m never positive that I understand where my family’s medicine is coming from and the status of the sites involved in manufacturing and distributing the product.

Leaders in the Way

In “How Leaders Get in the Way of Organizational Change” in Harvard Business Review, Ron Carucci discusses ways leaders can create problems in change.

The three main pain points he discusses are:

  • Scope naiveté: Underestimating the work
  • Change laziness: Overestimating the organization’s capacity
  • The perceived pet project: Misjudging how others see you

Great article, I strongly recommend reading it.

For each of these democratic leadership is an effective path to avoiding.

  • Idealized Influence: By holding oneself accountable you spend the time to understand the organization’s capacity
  • Inspirational Motivation: Moving from pet project to what is best for the organization
  • Intellectual Stimulation: Strive to overcome scope naiveté
  • Decentralized decision-making: Get the organization bought in to accelerating the change
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