Well, it’s official.
FDA’s drug review and drug safety offices have set aside their differences and hammered out an agreement that more equally divides regulatory authorities on issues related to drug safety.
This is a significant change in drug safety policy at FDA: the Office of Surveillance & Epidemiology—seen by some drug sponsors as not quite as friendly to industry as the Office of New Drugs—will now have a greater voice on regulatory issues related to drug safety. In the past, OSE had served in more of a consulting role to OND.
This brave new world was pushed by Center for Drug Evaluation & Research director Janet Woodcock as part of the “Safety First” initiative in response to some very public disagreements between FDA officials on drug safety issues. (You can read more about that in an interview with Woodcock that appeared in The RPM Report.)
While we wrote about the plan to redraw the lines of authority in a previous post, we just got our hands on the memorandum of agreement that makes the deal final. The MoA—between Office of New Drugs director John Jenkins and Office of Surveillance & Epidemiology director Gerald Dal Pan—took effect June 30 and was announced to FDA employees by Woodcock on July 1.
Under the agreement, the drug review and drug safety offices will share equal responsibility on “significant safety issues” for pending and approved products.
Examples include:
1) Safety labeling changes;
2) Submitting and implementing a REMS;
3) Requiring a post-marketing study or clinical trial;
4) Discontinuing marketing of a product;
5) Implementing an educational plan; and
6) Modifying promotion or advertising
Any disputes would be referred to Woodcock; both Dal Pan and Jenkins expect most issues will be resolved without involving the CDER director. Speaking during a town hall meeting at the Drug Information Association annual conference last week, Dal Pan said it will be a “very rare occurrence” to go to Woodcock—or even the office directors themselves—to resolve a difference of opinion. Most disputes will be handled by the office staff, he said.
Under an even bigger change, OSE will be designated as the lead office for certain regulatory actions regarding drug safety:
1) Observational epidemiological studies; and
2) Medication error prevention, including the proprietary name review process
Perhaps even more importantly, OSE will eventually add additional authorities as it staffs up its office and builds its organizational capacity, including pharmacovigilance activities, risk management plans, and the review of carton and container labeling and packaging.
While authority over regulatory actions associated with approvals will continue to reside at OND, responsibility for certain approvals of supplemental applications will eventually be transferred to OSE, the agreement says.
Woodcock said she sees the agreement as “just the first major step” toward creating a new culture at CDER—one that “supports the work of multidisciplinary teams, provides an environment where each member of the team has an opportunity to express his or her view, and ensures an avenue for promptly raising unresolved differences of opinion through the management chain for prompt resolution.”
While we wrote about the plan to redraw the lines of authority in a previous post, we just got our hands on the memorandum of agreement that makes the deal final. The MoA—between Office of New Drugs director John Jenkins and Office of Surveillance & Epidemiology director Gerald Dal Pan—took effect June 30 and was announced to FDA employees by Woodcock on July 1.
Under the agreement, the drug review and drug safety offices will share equal responsibility on “significant safety issues” for pending and approved products.
Examples include:
1) Safety labeling changes;
2) Submitting and implementing a REMS;
3) Requiring a post-marketing study or clinical trial;
4) Discontinuing marketing of a product;
5) Implementing an educational plan; and
6) Modifying promotion or advertising
Any disputes would be referred to Woodcock; both Dal Pan and Jenkins expect most issues will be resolved without involving the CDER director. Speaking during a town hall meeting at the Drug Information Association annual conference last week, Dal Pan said it will be a “very rare occurrence” to go to Woodcock—or even the office directors themselves—to resolve a difference of opinion. Most disputes will be handled by the office staff, he said.
Under an even bigger change, OSE will be designated as the lead office for certain regulatory actions regarding drug safety:
1) Observational epidemiological studies; and
2) Medication error prevention, including the proprietary name review process
Perhaps even more importantly, OSE will eventually add additional authorities as it staffs up its office and builds its organizational capacity, including pharmacovigilance activities, risk management plans, and the review of carton and container labeling and packaging.
While authority over regulatory actions associated with approvals will continue to reside at OND, responsibility for certain approvals of supplemental applications will eventually be transferred to OSE, the agreement says.
Woodcock said she sees the agreement as “just the first major step” toward creating a new culture at CDER—one that “supports the work of multidisciplinary teams, provides an environment where each member of the team has an opportunity to express his or her view, and ensures an avenue for promptly raising unresolved differences of opinion through the management chain for prompt resolution.”
image from flickr user billogs used under a creative commons license.
1 comment:
How safe is the off-label use of Etanercept for Alzheimer's disease patients. Ed Silverman unearths many serious questions on the practices of Dr. Edward Tobinick
http://www.pharmalot.com/2008/07/enbrel-alzheimers-and-a-controversial-doctor/
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