The next generation of consumer health products, including Rx-to-OTC switch opportunities, may work in concert with cutting-edge diagnostic tools and elements of personalized medicine, says Andrew Fish.

Fish, executive director of AdvaMedDx, the Advanced Medical Technology Association's in vitro diagnostics subsidiary, said expanding consumer access to diagnostic tests at the point of purchase or used at home could help consumers choose OTC drugs to better meet their individual needs.

"The more information that you can put in a consumer's hands and brain when they're standing at the shelf or they're home researching a condition … that's information that then becomes very powerful when they're making decisions and trying to decide what products to pull off the shelf," he said May 6 at the Consumer Healthcare Products Association's Regulatory & Scientific Conference in Bethesda, Md.

He said drugstores and pharmacies could house kiosks that analyze consumers' saliva, for example, and return personalized information to suggest a product selection or spur further discussion with a pharmacist.

"That is a totally, I think, realistic scenario – regulatory considerations aside, which I'm sure can be addressed at some point," Fish said.

"I hesitate to use the words 'third class,' but … there's sort of a continuum and a variety of models that could be used to help drive products that are now entirely within the health care system, more into the consumer setting." – AdvaMedDx Executive Director Fish

"From a technological standpoint, I think the possibilities are very much there, and the utility for consumers and for … manufacturers, I think, also should be fairly clear," he added.

As CHPA's former senior VP for legal and government affairs and general counsel, Fish can speak with authority on both the OTC pharma and diagnostic industries (Also see "CHPA Splits Roles Of Government Affairs VP, General Counsel And Secretary" - Pink Sheet, 10 January, 2011.).

Genetics Breed Specifics In OTCs

Advanced diagnostics might become more necessary should firms decide to develop OTCs and nutritionals designed for consumer segments with specific genetic attributes, Fish said.

Now that geneticists can fairly accurately predict an individual's taste and smell preferences, as well as other characteristics, based on DNA markers, firms would be wise to use such information to market more efficacious products, he said.

Fish said Nestle, with its work on sequencing the cocoa genome, and Procter & Gamble, with its Doctor's Dermatologic Formula cosmeceuticals line backed by research on the genetics of skin aging, already are getting their feet wet (Also see "North Castle Is Optimistic About Naturals, Discusses Ex-Brands Avalon, DDF" - HBW Insight, 15 September, 2008.).

Antiperspirants tailored to individuals based on how much they sweat and digestive products with probiotic strains for specific gastrointestinal issues are natural growth areas in which genetics research could apply, Fish said (Also see "Phillips Probiotic Recognizes Bacteria's Strength Is In Numbers" - Pink Sheet, 5 July, 2010.).

New Horizons For Switch

Diagnostics additionally could facilitate Rx-to-OTC switches, Fish said, or at least enable certain drugs to move from prescription status to behind the counter.

"I hesitate to use the words 'third class,' but you understand the point here – that there's sort of a continuum and a variety of models that could be used to help drive products that are now entirely within the health care system, more into the consumer setting," he said.

Fish's notion appears already to have traction at FDA. Janet Woodcock, director of the agency's drug center, recently voiced support for BTC switches to help overcome self-selection concerns linked to certain drugs (Also see "CDER Director Sees Behind-The-Counter Switches As Best Bet" - Pink Sheet, 11 April, 2011.).

While diagnostics could fill in some information gaps for consumers, at least one audience member at RSC was fully aware that additional information alone is not sufficient to allow for self-selection and safe use.

Edwin Hemwall, an executive in Merck's consumer health group, said during a Q&A session that Merck found during its attempts to switch Mevacor (lovastatin) that knowledge of one's cholesterol levels does not guarantee a consumer will select and use the statin appropriately in an OTC setting (Also see "Crestor Indication Grows User Pool, But Self-Selection Hinders Statin Switch" - Pink Sheet, 1 March, 2010.).

"What we learned was that, even though you knew your cholesterol numbers, if you were slightly low or slightly high, or even markedly low or high, there were people that wanted to use the product anyway," Hemwall said.

"So it is really boiling down to: What do you do with the information?" he added.

HIV Tests Offer Lessons For OTCs

An FDA presenter at RSC suggested there could be parallels between drug switches and the gradual process of bringing rapid HIV test kits into the home setting.

The agency's Blood Products Advisory Committee has hosted three meetings on OTC home-use HIV diagnostics, most recently in November 2009, and Elliot Cowan of the Center for Biologics Evaluation and Research said more meetings are in the works.

Cowan, head of the Product Review Branch in the Division of Emerging and Transfusion Transmitted Diseases, said the benefits of such a product – including encouraging more people to test themselves, leading to earlier diagnosis and clinical intervention – are clear.

Of course, the risks of OTC HIV tests are apparent as well. False positives and negatives are real possibilities, especially given that HIV antibodies are undetectable by any test until at least 10 days post-exposure, said Cowan.

"There are now no previously approved home-use test kits for any infectious disease out there, so this is very new territory," he said.

FDA has opted "to defer to the manufacturing side to see if they can come up with ways to convince us that the psychological impact of a test result will be addressed." – CBER official Cowan

In late 2010, OraSure Technologies gained FDA's go-ahead to begin the final clinical testing phase for its OraQuick Rapid HIV-1/2 Antibody Test, intended for OTC sale (Also see "In Brief" - Pink Sheet, 6 December, 2010., In Brief).

While delivering diagnostic information in an OTC setting is relatively straightforward, how consumers react psychologically to a positive HIV test result, for example, is something firms must consider, Cowan said.

FDA has opted "to defer to the manufacturing side to see if they can come up with ways to convince us that the psychological impact of a test result will be addressed," he said.

"We don't presume to have all of the answers, and we'd rather rely on the ingenuity and the creativity of industry to try to address that. We can at least let them know what the need is," Cowan added.

Ultimately, should HIV tests for home use gain OTC approval, it could signal a new day for statins and other drugs that might switch with the benefit of a companion diagnostic kit, said session moderator David Hilfiker, director of global regulatory affairs at Johnson & Johnson.

"If they can switch a home-use test with that much concern associated with people getting their result, we should be able to find ways to switch tests that have lesser impact like knowing your cholesterol number," he said.

By Dan Schiff

The Future Of OTCs: Self-Selection Meets Diagnostics, Genetic Personalization

More from Archive

More from Pink Sheet