FDA says OTC drug oversight remains important even as the Office of Nonprescription Products loses star billing within the Office of New Drugs, but the change could challenge firms to convince the agency to prioritize regulation of their products.

Effective March 15, FDA will rename ONP the Office of Drug Evaluation IV, and will give it responsibility for the newly formed Division of Medical Imaging Products, the agency said March 9.

Additionally, the Division of Nonprescription Clinical Evaluation and the Division of Nonprescription Regulation Development will continue as units of ODE IV, an agency spokeswoman confirmed in an e-mail.

"OTC drug products [will] remain a priority in the Office of New Drugs and in the Office of Drug Evaluation IV," she added.

The agency spokeswoman said Charles Ganley, current director of the Office of Nonprescription Products, will be head of ODE IV, supervising the OTC and imaging offices.

Ganley at the helm should benefit OTC drug manufacturers because of his history with their products, said Cindy DiBiasi, a consultant with 3D Communications. Ganley might be able to keep a spotlight on nonprescription products, she said.

Ganley has led ONP since it was elevated from a division to full office status in the spring of 2005 (¹ Also see "FDA OTC Head Ganley Talks Third Class, Plan B And Drug Switches" - Pink Sheet, 1 January, 2005.).

Will Combo Kill OTC Focus?

Some industry experts say the combination of the seemingly disparate areas of nonprescription and medical imaging products hints at a potentially diminished status for nonprescription products at FDA.

The Center for Drug Evaluation and Research reorganized its Office of New Drugs into six ODE review divisions - each with the same name distinguished by a sequential roman numeral - to "enhance the logical groupings of applications" and "achieve a more balanced workload," according to a release.

However, the combination of medical imaging and nonprescription products "doesn't seem like a fit," and it is unclear what the synergies between the two areas might be, DiBiasi said.

The agency may have combined the two because it perceived ONP as not having as heavy a workload as other offices, making it better positioned to take additional responsibilities, said a food and drug lawyer who asked not to be named.

The change raises the question of whether FDA is "looking at the OTC pipeline and considering there will be less work and, therefore, reallocating its resources," agreed Bill Soller, professor and executive director of the Center for Consumer Self Care at the University of California, San Francisco, School of Pharmacy.

"I think in some respects we have to believe the government is hit by a poor economy as well, so it is looking at ways it can make the best use of resources and reallocating people as a priority," said Soller, a former Consumer Healthcare Products Association executive.

What's In A Name?

Dropping "nonprescription products" from the name "seems like a gratuitous slap," even if the change was simply to make the name more uniform, and sends an unintended message the office was not working as hard or is not as important as other FDA areas, said the food and drug lawyer.

Soller added this perception creates a challenge for the industry to show FDA why an office dedicated to nonprescription products is a priority.

He encouraged the industry to consider initiatives the office completed in the last few years, what role the industry played in shepherding those developments and how the industry can do more in the future.

For example, he recommended the industry consider what steps to take to support potential switches, including what kinds of data it could and should gather. Industry also should consider how it can help the office complete outstanding tasks, such as finalizing several monographs.

Realignment Should Not Impact Review Process

The shuffle will cause some applications for new drugs, investigational new drugs and biologics licenses and other work to move to new ODEs, but the changes should not significantly impact the review process, FDA said.

It explained "the majority of FDA staff members evaluating those applications have been concurrently reassigned" to the new divisions, allowing the applications to retain their current numbers and due dates.

Indeed, the FDA spokeswoman confirmed "all of the staff previously involved in the review of nonprescription applications will continue in those roles."

As a result, DiBiasi said the addition of medical imaging products to the former ONP will not dilute the agency's current level of attention to nonprescription products.

The Division of Medical Imaging Products was formerly part of the Division of Medical Imaging and Hematology Products, which is now simply the Division of Hematology Products, according to FDA.

Pairing hematology and imaging products did not make much sense either, and some lawyers in the imaging area see the move to Ganley's office as positive. One FDA lawyer postulates the new ODE IV may be "more reasonable" and give more attention to medical imaging than oncology gave it.

FDA also switched rheumatology products from the current Division of Anesthesia, Analgesia and Rheumatology Products, which will become the Division of Anesthesia and Analgesia Division, to the current Division of Pulmonary and Allergy Products, which will become the Division of Pulmonary, Allergy and Rheumatology Products, according to the announcement. Both divisions will be within ODE II.

- Elizabeth Crawford ( ² e.crawford@elsevier.com )

FDA's ONP Reorganization Challenges Industry To Prioritize OTCs

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