ReportersNotebook — Over the Counter, 6/25/12
SUPPLIER NEWS — Biolife in May launched WoundSeal, a hemostat product specifically targeting Americans on a regimen of blood thinners. While hemostat products have been introduced into the first aid set before, this is the first one targeting patients on a specific therapy.
According to the company, as many as 52 million Americans are taking blood thinners, and 11% stop taking those medicines because of “nuisance bleeding.” The company already is working on a line extension for the product — WoundSeal for Nosebleeds — that includes a specially designed applicator for nosebleeds or other hard-to-reach areas like head wounds.
MarcasUSA in May announced the U.S. debut of Conazol, a leading over-the-counter athlete’s foot treatment in Mexico. The brand is expanding its U.S. distribution and can be found at such retailers as Walmart and Target in key U.S. Hispanic markets, including Los Angeles, Houston, Dallas and Chicago, the company stated.
That marks the second Mexican company to seek entry into the U.S. mass marketplace in the past few months. Genomma Lab Internacional recently attempted to expand its product portfolio with its proposed-and-rejected acquisition of Prestige Brands.
Genomma already is distributing product through mass retail outlets, according to the company’s website, and currently boasts more than 78 brands in its product portfolio.
Hispanics represent one of the fastest-growing demographic groups in the United States. According to the Census Bureau, the Hispanic population grew from 35.3 million in 2000 to 50.5 million in 2010, a 43% increase. In 2010, Hispanics represented a little more than 15% of the total U.S. population. By 2050 the U.S. Census Bureau projects there will be more than 100 million Hispanic-Americans, representing almost 25% of the U.S. population. And Hispanics skew younger as compared with Americans overall — the median age among Hispanics is 28 years old versus 37 years old for the general American population, according to Nielsen research.
Divergent pathways in switch paradigm
While the picture of a new Rx-to-OTC switch paradigm is being painted with a broad stroke brush, already there are two divergent pathways emerging around what that new paradigm landscape might look like.
OTC manufacturers have been framing the new paradigm within the existing two-drug-class system, suggesting that the diagnostic tools that already are available in the marketplace significantly could help expand which medicines are considered appropriate in the OTC space.
Retail pharmacists, on the other hand, are advocating for the creation of a third class of drugs.
Pharmacists advocate that third-class codification primarily to create a set of clinical standards that would help identify which medicines would require a pharmacist intervention, and define exactly what that role would be — whether that intervention would be in tandem with a primary care physician, for example, or establish a treatment protocol exclusive of the PCP.
Reimbursement also is a concern for pharmacists. Codifying exactly what kind of clinical intervention by the pharmacist would be required to successfully switch a new-paradigm medicine would be used to justify appropriate compensation for services rendered.
However, a behind-the-counter class of drugs could become problematic as it establishes a new regulatory bucket in which pre- existing OTC medicines can be thrown. Worried that your child may be chugging dextromethorphan with their friends? That sounds like a good BTC candidate. Feeling exasperation that basement meth cooks still are figuring out how to feed their pseudoephedrine need from retail? Require that it be sold BTC.
PSE already is mandated for sale from behind the counter, of course. But it took an act of Congress to make that happen.
There is one theme around which the two groups agree — expanding the switch paradigm must serve to broaden access to appropriate medicines. And the reasons driving those switches must be clinical in nature, as opposed to regulatory or legislative.
PSE restriction, OTCS in FSAs remain focus of legislation
Currently there are two overarching legislative issues that either threaten to place greater restrictions on certain over-the-counter medicines or fail to restore access to an OTC benefit that once played a significant role in helping develop interest in the flexible spending account plans available today.
Regarding the cough-cold medicine sold from behind the pharmacy counter, no states embraced a prescription-only mandate on the sale of pseudoephedrine this year, representing a score for the OTC industry. As many as 23 states currently implement the industry-funded National Precursor Log Exchange, with six states having passed legislation in their current sessions. NPLEx bills still are very much active in three states — Hawaii, Ohio and New York — according to the Consumer Healthcare Products Association. Hawaii’s NPLEx legislation is waiting for a governor signature; Ohio’s legislation passed its House and now is before the Senate; and New York’s legislation recently came out of the Senate committee. NPLEx legislation also is still alive in California, though that legislation is not expected to come out of the current session.
In 2011, as many as 2 million grams of PSE that exceeded sales restrictions had been blocked by the NPLEx stop-sale system.
Earlier this month, the House of Representatives voted in favor of the Protect Medical Innovation Act of 2012, which would reinstate OTC medicines as eligible expenses under FSAs without the requisite prescription. The bill since has moved to the Senate for consideration.
“[With this bill] we are making it easier for Americans to be in charge of both their health care and their finances,” stated Rep. Tim Huelskamp, R-Kan., who co-sponsored the legislation.
While that industry- supported bill is being debated on the Hill, the real question lay with the Supreme Court. If the Supreme Court nullifies the Patient Protection and Affordable Care Act in June, then OTCs should become eligible for FSA reimbursement again.