HEALTH

Report: New FDA switch paradigm could bring $36 billion in prescription revenue to the front end

BY Michael Johnsen

MONMOUTH BEACH, N.J. — A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International. 

Titled "A New FDA-Driven Rx-to-OTC Switch Initiative: The Expansion of Conditions of Use," the report outlines new potential Rx-to-OTC switch candidates that would qualify under a new switch paradigm under consideration by the Food and Drug Administration, and identifies possible building blocks in developing a switch application. "For example, combining a drug with new smartphone technology could create potentially valuable OTC opportunities in several therapeutic categories," the company stated. Enabling access to OTCs through technology or consults with retail pharmacists and clinicians could bring prescription-only medicines like statins into the mass market, Francesco noted. Other potential switch candidates identified by Francesco in the report include medicines for hypertension, benign prostate hyperplasia, chronic obstructive pulmonary disorder and erectile dysfunction. "Under these new conditions of safe OTC use, the quality of life for the consumer could be significantly enhanced, and overall healthcare costs could be reduced without the need for constant physician involvement," the company added. 

“There is the chance for change as the major stakeholders are now starting to re-think their business models, and some of these new opportunities, especially those from the new healthcare legislation and the contribution of new technology, are becoming apparent and actionable," stated Steve Francesco, CEO of Francesco International. "The FDA sees this as an opportunity. As experts on the subject, we can see some new conditions of safe use having a potentially huge positive impact on both public health, as well as healthcare industry sales and profit."

The FDA last year held a public meeting attempting to identify switch pathways that would expand the class of medications considered appropriate for sale without a prescription today. The FDA is working with Brookings Institute and a number of switch experts, including Francesco International, on the Nonprescription Safe Use Regulatory Expansion initiative. Brookings hosted one meeting in December; the next is planned for May 9.  


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Smoking rates significantly higher among mentally ill, report finds

BY Alaric DeArment

ATLANTA – Smoking among adults with mental illnesses is 70% higher than among those without them, according to a new report from the Centers for Disease Control and Prevention.

The CDC, collaborating with the Substance Abuse and Mental Health Services Administration, found that 36% of adults with a mental illness are cigarette smokers, compared with 21% of those without mental illnesses. Mental illnesses affect nearly one-in-five adults in the United States, according to the report, and among them, smoking prevalence is especially high among those in younger age groups, Native Americans and Alaska Natives, those living in poverty and those with lower levels of education. Differences were also found between states, with ranging from 18.2% of mentally ill adults in Utah to 48.7% of those in West Virginia.

"Smokers with mental illness, like other smokers, want to quit and can quit," CDC director Tom Frieden said. "Stop-smoking treatments work, and it’s important to make them available to all people who want to quit."

The study, which combined data from the CDC and SAMHSA, found that smokers with mental illnesses smoked an average of 331 cigarettes per month, compared with 310 among those without mental illnesses.

"Special efforts are needed to raise awareness about the burden of smoking among people with mental illness and to monitor progress in addressing this disparity," SAMHSA administrator Pamela Hyde said.

SAMHSA and the Smoking Cessation Leadership Center have developed a portfolio of activities designed to promote tobacco cessation efforts in behavioral health care, including the 100 Pioneers for Smoking Cessation Campaign, which provides support for mental health centers and organizations in their smoking-cessation efforts.


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Prestige Brands: Looking forward to January cough-cold reorders after strong Q3

BY Michael Johnsen

TARRYTOWN, N.Y. — Reporting on the third quarter ended Dec. 31, Prestige Brands’ CEO Matthew Mannelly told analysts Thursday morning he is "cautiously optimistic" regarding cough-cold reorders given the high consumption levels at retail in late December through January. 

"Cough-cold and flu incidence has [not] been rampant the entire season," Mannelly said. "It’s really mid- to late-December through January that it’s picked up. … You would have to be somewhat optimistic that with that pickup, in terms of consumer pull in mid- to late-December into January, that reorders would be coming in the fourth quarter."

Prestige provided some color as to just how strong that pickup in consumer consumption across the cough-cold category may be. For January 2013, the number of consumers impacted by a flu was up 27.6% as compared with January 2012, and up 21.4% as compared with a three-year average. 

"As you can see in the beginning of the [third] quarter, [retailers] were heavy [in cough-cold inventory] because they all took in at the end of Q2 in advance of cough-cold," Mannelly explained. "But since they’ve been working those down, inventory late December was at normal levels, and there was not excess inventory out there at retail."

So a strong cough-cold season couldn’t be the only factor driving strong third-quarter results at Prestige. The company reported revenues of $160.2 million for the third quarter ended Dec. 31, a 50.8% increase. "This was a tremendous quarter for us," Mannelly told analysts Thursday morning. "The bulk of our gains is really coming from increased velocity in terms of better merchandising performance," he said. "And also stronger consumer takeaway [from our] marketing spend that has [been] effective in driving people to shelves."

Prestige’s core OTC consumption growth outpaced category growth, the company noted, up 6.9% for the trailing 12 weeks compared to category growth of 3.2%. Across Prestige Brands’ OTC healthcare segment, revenues totaled $139 million, 63.7% higher as compared to the year-ago period. 

“The health of our core OTC brands, well-executed advertising and promotional initiatives, and the strength of our balance sheet all contributed to the success of our third-quarter and nine-month results,” Mannelly said. “We delivered record third-quarter revenues, backed by solid performance in our core OTC brands."

Among the brands which reported consumption gains were BC and Goody’s, PediaCare, Dramamine, The Doctors, Little Remedies, Clear Eyes and Chloraseptic, Prestige noted.


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