FDA's drug review and drug safety offices have set aside their differences and laid out an agreement that more equally divides regulatory authority on issues related to drug safety.

The terms of the agreement are listed in a ¹ memorandum of agreement announced July 1. Signing of the MoA by OND Director John Jenkins and OSE Director Gerald Dal Pan as well as Woodcock was delayed due to local infrastructure problems (² 'The Pink Sheet,' June 30, 2008, In Brief).

The MoA represents a significant change in drug safety policy at FDA: the Office of Surveillance and Epidemiology - seen by some drug sponsors as less friendly to industry than 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; now if the two offices disagree, the matter will be referred up the agency's chain of command.

The agreement was pushed by Center for Drug Evaluation and Research Director Janet Woodcock as part of the "Safety First" initiative in response to disagreements between FDA officials on drug safety issues.

The "Safety First" initiative is intended to apply a PDUFA-like approach to the post-market drug safety activities (³ Also see "Safety First: FDA Unveils New Postmarketing Management Process For Safety" - Pink Sheet, 3 March, 2008., p. 4).

Under the agreement, the drug review and drug safety offices will share equal responsibility on "significant safety issues" for pending and approved products.

Examples of significant safety issues include:

Safety labeling changes
Submitting and implementing a REMS
Requiring a post-marketing study or clinical trial
Discontinuing marketing of a product
Implementing an educational plan
Modifying promotion or advertising

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:

Observational epidemiological studies
Medication error prevention, including the proprietary name review process

Perhaps even more importantly, OSE will eventually add more 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.

The office is going through a reorganization to accommodate a 50 percent staff increase to fulfill the requirements of the FDA Amendments Act (⁴ Also see "FDA’s Drug Safety Office Reorganizing To Accommodate Influx Of PDUFA Staff" - Pink Sheet, 25 February, 2008., p. 5).

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."

- Kate Rawson (k.rawson@elsevier.com)

FDA Drug Review, Surveillance Offices Agree To Share Safety Authority

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