FDA’s Rosebraugh Says OTC Labeling Studies Should Be More Rigorous

OTC drug manufacturers and FDA should collaborate to raise the quality of actual use and label comprehension studies to the level of clinical trials, according to OTC Drug Division Deputy Director Curtis Rosebraugh, MD.

"There is a lot more attention being paid to actual use and label comprehension studies," Rosebraugh said during a Nov. 7 FDA update on OTC issues at the Consumer Healthcare Products Association Regulatory & Scientific conference in Washington, D.C.

"I think that some of the divisions feel that there's an inability for us to predict consumer behavior or influence consumer behavior, and that should really be a call to both of us that we need to spiff up these actual use/label comp studies," Rosebraugh said.

"We need to get them to the point that they enjoy the same evidentiary clout as a traditional randomized trial," he contended. "That will further the cause of switching drugs more than anything else."

"Anything we can do to make it so that the data we generate are respected, such that anyone that has a preconceived notion of why something can't be OTC can be outshouted by the evidence we present will further the cause of switching drugs."

Industry could look for product innovation, in other areas as well, beyond switches in chronic categories, Rosebraugh suggested.

"Look at some of our existing categories, particularly monograph-type drugs, some of the older drugs, and say 'are we happy with where we're at with those?'" he asked. The FDAer pointed to the antitussive category as an example.

"When you talk about the oral antitussive agents, you are really more or less talking about dextromethorphan," Rosebraugh said. "We now have some reports in the literature about misuse by our nation's youth of dextromethorphan."

The situation highlights the lack of an adverse event reporting system for monograph drugs, an issue FDA is examining, he noted. "It also points out that we have limited choice in this category, so there is a need" for more drugs in the category.

Regarding potential profitability, Rosebraugh pointed out that cough/cold products led OTC categories in 2002 with $3 bil. in sales.

"If you were to introduce a new antitussive agent into this market that had a different efficacy/safety profile, I suspect it would be fairly successful."

Rosebraugh cited the switch of loratadine as an example where the new entry brought a different safety profile to an existing category with few options.

"My challenge to the industry would be, is there any innovation going on in some of these other categories where we have limited choices?"

Rosebraugh identified the time and extent application process for bringing foreign drugs to market in the U.S. as another area of opportunity for companies. The agency issued a final rule on TEAs last year (¹ (Also see "FDA “Material Time, Material Extent” Rule May Be Cloudy For Sunscreens" - Pink Sheet, 28 Jan, 2002.), p. 5).

However, Rosebraugh noted there has been "not much" activity on that front. Only seven applications have been filed during that time, primarily by drug substance manufacturers rather than pharmaceutical companies.

"There are some opportunities out there that haven't been utilized," he said. For example, only two of 10 cough suppressants, expectorants and mucolytics available around the world are approved in the U.S. The figure for analgesics worldwide is nearly five times the U.S. number.

Rosebraugh admitted that FDA needs to make the process more efficient. To date, applications have taken an average of 11 months to receive an eligibility ruling.

Furthermore, the financial incentive for firms to use the TEA process may be weak, considering no marketing exclusivity is granted the applicant.

The OTC deputy director expressed enthusiasm for the Rx-to-OTC switches over recent years, including H2 blockers, antihistamines, antifungals, smoking cessation products and a proton pump inhibitor.

"Consumers have their own ability to dictate their own smoking cessation programs, I think that's incredible," he said."

As far as the future of OTC approvals goes "that's really hard to predict," he cautioned. "Who would've thought Prilosec would be on the market now?"