Talk to FDA Early and Often
In the Rx-to-OTC switch process—as with the development of any new, prescription drug—FDA may well take a different perspective
of the data from the sponsor. But viewing the agency as an adversary can be a big mistake.
"We're not here to be an obstacle," said Charles Ganley, MD, director of FDA's division of OTC drugs. "FDA is charged with
speeding access to safe and affordable medicines, and we have an obligation to help companies figure out a way to do that."
The difference between success and failure may come down to simply talking to FDA early on in the application process—preferably,
before submitting the Investigational New Drug Application (IND) for the Rx-to-OTC switch. These early meetings allow sponsors
to determine whether their proposed OTC clinical development program—efficacy and safety trials, and possibly comprehension
studies to determine the accessibility of the label—is adequate for FDA to approve the switch.
The agency is generally very open to these types of meetings, as long as the objectives are clear and sponsors have a proposed
OTC clinical-development plan. Companies may not always get the answers they want. But the interaction provides sponsors
a chance to share their views with FDA—and more importantly—to fully understand the agency's perspective on the data.
"It is best to identify and confront issues head-on and try to negotiate a win-win situation," said Bierer. "Failing to fully
understand the FDA's position—whether the issue is dosing, duration of therapy, or anything else—just causes a loss in time
and frustrates both the sponsor and FDA."
Did You Know?
As time goes on, sponsors should request follow-up meetings with FDA, and share their own evolving rationale for the switch.
Companies should also continually ask regulators if they agree with their analysis.
If they don't, Ganley advises sponsors not to give up, but rather to ask what additional information FDA would need to approve
Ganley sees such negotiations as an integral part of FDA's decision-making process for potential Rx-to-OTC switches. "It's
easy to just say, 'No, the switch can't be done,'" said Ganley. "It's much more scientifically challenging [for FDA] to have
to explain their specific objections and then figure out what data might be necessary to overcome them."
Mission Possible: The Right Label
Consumers buy OTC drugs right off the shelf, without the benefit of physicians' or pharmacists' advice. Therefore, FDA ranks
consumers' ability to read and follow a product's label—including its Drug Facts section—as one of the most critical elements
to consider during an Rx-to-OTC petition. The label must contain all the information consumers need to decide if this is the
right medicine for them and how to use the product appropriately.
"It's quite challenging to get all of the necessary information into the very small space on the label," said Louis Cantilena,
MD, a professor for the Uniformed Services University of the Health Sciences. Cantilena served as a member of the original
NDAC, and chaired that committee from 2001 to 2005. He also serves as a consultant to the pharma industry. "I advise companies
to develop clear and consistent messages about the product's safety and efficacy, how it works, who is supposed to use it
and how they should use it, very early in the process and make certain that the wording in Drug Facts clearly conveys this
information to consumers," said Cantilena.