PHARMACY

GPhA’s Neas criticizes FDA for GDUFA delays

BY Lesley Thulin

WASHINGTON — Ralph Neas, president and CEO of the Generic Pharmaceutical Association, issued a statement Monday criticizing the FDA at the organization’s public meeting on the Generic Drug User Free Act.

“It is industry opinion that the FDA is falling short of meeting its commitment to GDUFA goals, resulting in decreased access for patients and billions of dollars in lost savings,” Neas said.

As the GDUFA nears its Sept. 2017 expiration date, the FDA is holding a hearing regarding re-negotiations. The GDUFA aims to provide widespread access to generic drugs and cut down on industry costs, according to the FDA’s website. It requires industry to cover user fees in order to “supplement the costs of reviewing generic drug applications and inspecting facilities.” 

GDUFA is also designed “to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.”

But with a generic drug application backlog of 4,000 and counting, the average time for reviewing applications is only increasing. The median review time has steadily increased from 30 months when GDUFA began in 2011. From FY2012 to FY2015, it rose to 31, 36, 42, and 48 months, respectively.

These delays “contribute significantly” to rising health care costs and affect millions of patients’ access to pharmaceuticals, Neas added. Industry experts estimate that the U.S. health care system lost more than $3 billion in savings due to first generic approval delays over the last year and a half.

“Millions of patients, businesses, taxpayers, prescribers, dispensers and others deserve better from the FDA,” Neas said.

In light of this lag, Neas said it was “especially confounding” that the FDA still has $277 million in unused funds from the generic industry, pointing out that these funds “could be applied to site inspections or approvals.”

Neas said he hopes the FDA will improve communication between the agency and manufacturers. 

“Without more meaningful transparent correspondence, generic manufacturers are unable to plan for the critical steps in the market entry processes,” he said.

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NCPA event unveils the 4 factors to ensure independent success in specialty

BY Michael Johnsen

ALEXANDRIA, Va. — Saying that specialty pharmacy represents a significant growth driver for independent pharmacists may be underselling it a bit. The truth is, specialty pharmacy may very well represent the future lifeblood of independent pharmacy — especially as health systems and payers become more inclined to direct prescription traffic toward pharmacy operators ready to deliver better outcomes for their patients. 
 
It may seem that the kind of face-to-face patient-practitioner interactions that are considered a staple at independent pharmacies across the country may lend itself to intense disease-state and medication therapy management, but the fact is independents face significant hurdles entering the specialty business, and more challenges competing within that space once they're there. 
 
To help independents clear those hurdles and compete in the specialty space, the National Community Pharmacists Association last week hosted a well-attended day-long seminar here titled “NCPA Specialty Forum – Exploring the intersection of specialty medications, community pharmacy and patient care.”
 
One-third of the pharmacy business already consists of specialty pharmaceuticals, noted Doug Hoey, NCPA CEO. The market is growing fast and independents need to incorporate specialty into their business models or risk being left behind. 
 
And independent pharmacy needs to play a role, added Paul Levesque, director corporate pharmacy development for Value Drug Company, because if you funnel all of these specialty patients into mass outlets, there is the potential for diluting the level of care. If independent specialty pharmacy operators are excluded from being able to compete, that's a problem, he said. 
 
Hoey told Drug Store News that the seminar served two purposes. First, the focus on outcomes-based management and the role independents can play within that space really tells that payers and manufacturers that independents want the business, Hoey said. And second, the seminar helps inform membership on what payers and manufacturers are looking for in partnering with an independent pharmacy. 
 
The event was certainly helpful, Michael Kim, owner and president Grubb's NW Specialty Pharmacy, told Drug Store News.
 
“Hearing how other people are doing things is a big help,” he said. “It helps spark ideas.” Kim is currently focused on methodically expanding his location's specialty reach.
 
”It's important to get each disease-state right, because each disease-state is a little bit different in what you have to to do, how you take care of the patients and how you communicate with the physicians,” Kim said.
 
Dan Mendelson, CEO of Avalere Health, kicked off the session with a keynote address that defined the specialty market and the role independents can play within it.
 
“Pharmacists continue to be one of the most trusted professions in the United States and go into [the legislature] with a very strong basis of support among legislatures. At the state level, pharmacists continue to have very strong representation,” he said. Juxtaposed against that is the ability to deliver on healthcare cost containment. “That's really where the strategy has to come in," he said. "As the world changes and as there are more capable organizations … the question really becomes how do you fit into [managing potential care].”
 
“The opportunity for community pharmacy is really to define community pharmacy as the place people can go for certain illnesses,” Mendelson added. 
 
Mendelson outlined four keys factors for independents to consider when entering the specialty space:
 
  1. There has to be a clinical value proposition that community pharmacy operators deliver beyond distribution of generic drugs at retail;
  2. There's an opportunity to really focus on disease states where there is a joint benefit to the health plan, patient and pharmacy;
  3. Community pharmacy needs to leverage their relationships with local providers in pursuit of disease-state and health condition management; and
  4. One of the bigger opportunities in ensuring success in the specialty space is data collection. "That data analytic aspect will drive [the business]," Mendelson said.    
“I really believe that specialty is an important component for pharmacy going forward,” Mendelson concluded. 
 
Later, Liz Helms, president and CEO of the California Chronic Care Coalition provided a patient's perspective on specialty pharmacy. Eighty-four cents of every dollar is being spent on chronic care, Helms explained. The next model of pharmacy is based on providing service, she said. 
 
The afternoon was spent reviewing independent specialty pharmacy models that are currently performing well in the marketplace and capped with a panel of executives representing many disciplines within specialty who each discussed the opportunities and challenges associated with the business. Moderated by Mike Johnsrud, SVP Avalere Health, that panel consisted of Ela Lourido, senior director, retail specialty network at Diplomat Pharmacy; Teri Smith Moore, of the U.S. Department of Health and Human Services, Office of Pharmacy Affairs; Tom Doyle, EVP commercial solutions at H.D. Smith Specialty Solutions; Rinku Patel, CEO KloudScript; Duane Barnes, VP specialty pharmacy and pharmacy benefit management for Amgen; and Mike Nameth, CEO Aureus Health Services. 
 
In addition to anecdotal advice from specialty pharmacy operators, Jimmy Neil, general manager Live Oak Bank, offered financing options for independents interested in entering the space.  
 
Drug Store News will be presenting video coverage, sponsored by Cardinal Health, of NCPA's event at a later date. 
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Survey: Half of sufferers turn to sleep aids

BY Michael Johnsen

As many as 39% of Americans feel restless when they sleep at least once or twice every week, and 27.5% feel restless at least three or four nights each week, according to a survey conducted in May by Field Agent on behalf of Drug Store News.

Most respondents turn to the Internet (41%) or family and friends (40%) to deal with their sleep problems. However, nearly the same amount (35%) do not seek advice from anyone.

And only half of consumers (50.5%) have used a sleep aid remedy in the past year. Of those, 84% opted for an OTC remedy. When shopping for an OTC sleep aid, nearly half (47%) will choose the lowest-cost option, and 41% will search for a natural remedy.

And yet, well-known brands continue to dominate the sleep aisle of the drug store. When asked which brand they had bought most recently, 48.2% had purchased a ZzzQuil product, and 44.7% placed Tylenol PM near their nightstand.

The survey of 200 respondents was conducted from May 26 to 28 by Field Agent, which provides business information and consumer insights by leveraging traditional methodologies and incorporating new, cutting-edge crowd-sourcing and mobile technologies to deliver real time information about purchasing behavior and attitudes. As many as 60% of the respondents were women, and 38% were between the ages of 31 years and 40 years.

To learn more about Field Agent, visit www.FieldAgent.net.

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