The issue at hand is opiods –but there’s a larger issue – how can the FDA, industry, physicians, pharmacists and patients work together to enhance the safe use of medicines.
The theory is that the way to make drugs “safer” is to ensure they are used appropriately.
And communications is the weak link in the chain. Hence REMS as a tool for safe use. Seems to make sense.
Presented for your consideration -- questions posed by the FDA in advance of a two-day public meeting set for May 27-28 on whether class-wide opioid REMS should include a certification process for prescribers, pharmacists and other heath care providers, a strong patient education component, and prescriber-patient agreements.
According to a report in the Pink Sheet, “Since FDA's announcement that it intended to seek the class-wide REMS in February, pharmaceutical companies have been charting new territory as they try to work together to develop a REMS framework for the whole class.”
Working together to advance safe use. Good idea. The Pink Sheet continues, “The evolution of the opioid class-wide REMS will set an important precedent for trying to get competitors to work together on post-marketing programs in the future.”
In short, competitors must also be allies in pursuit of the public health. And that means both innovator and generic companies.
Not easy. But important advances rarely are.
The theory is that the way to make drugs “safer” is to ensure they are used appropriately.
And communications is the weak link in the chain. Hence REMS as a tool for safe use. Seems to make sense.
Presented for your consideration -- questions posed by the FDA in advance of a two-day public meeting set for May 27-28 on whether class-wide opioid REMS should include a certification process for prescribers, pharmacists and other heath care providers, a strong patient education component, and prescriber-patient agreements.
According to a report in the Pink Sheet, “Since FDA's announcement that it intended to seek the class-wide REMS in February, pharmaceutical companies have been charting new territory as they try to work together to develop a REMS framework for the whole class.”
Working together to advance safe use. Good idea. The Pink Sheet continues, “The evolution of the opioid class-wide REMS will set an important precedent for trying to get competitors to work together on post-marketing programs in the future.”
In short, competitors must also be allies in pursuit of the public health. And that means both innovator and generic companies.
Not easy. But important advances rarely are.
