GPhA’s Neas criticizes FDA for GDUFA delays
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.
NCPA event unveils the 4 factors to ensure independent success in specialty
- There has to be a clinical value proposition that community pharmacy operators deliver beyond distribution of generic drugs at retail;
- There's an opportunity to really focus on disease states where there is a joint benefit to the health plan, patient and pharmacy;
- Community pharmacy needs to leverage their relationships with local providers in pursuit of disease-state and health condition management; and
- 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.
Survey: Half of sufferers turn to sleep aids
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.