This is the coming of the ‘age of generics’
WHAT IT MEANS AND WHY IT’S IMPORTANT — Astrologers would say this is the Age of Pisces, while the Chinese zodiac calls it the Year of the Dragon. For health care, it might be a good time to start calling it the "Great Generic Epoch."
The trend seen in the Generic Drug Savings study, in which generic drugs count for an overwhelming majority of prescriptions written but only about one-quarter of drug spending, has been happening for some time now. But it’s also accelerating, and that means a lot for drug makers and policy-makers alike.
(THE NEWS: Generics saved $1 trillion over last 10 years. For the full story, click here.)
According to a study last month by IMS Health, global spending on generics is expected to rise from $242 billion in 2011 to more than $400 billion by 2016. Much of that will come from volume growth in emerging-market countries, but a lot of it also is because of the transition to generics in developed countries like the United States, and the report noted that limited savings from expiring patents are prompting policy shifts to encourage more use of generics. And this has been going on for some time: Last year, another report by IMS found that while spending on branded drugs decreased by 0.7% in 2010, spending on branded and unbranded generics rose by 4.5% and 21.7%, respectively. That report also found that on average, more than 80% of a brand’s prescription volume is replaced by generics within six months of the expiration of the branded drug’s patent.
As such analysts as like IMS VP industry relations Doug Long have said before, the blockbuster model of drug development is coming to an end. While drug companies might still develop new treatments for widespread disease states, such as cholesterol and gastroesophageal reflux disease, new drugs to treat those conditions are unlikely to see the kinds of sales achieved by the likes of Pfizer’s cholesterol drug Lipitor (atorvastatin), whose sales reached $7.7 billion in 2011, but lost its patent protection in November 2011. Instead, many drug companies are shifting their focus to more expensive drugs to treat disease states with smaller patient populations, including cancers and autoimmune disorders. Meanwhile, the more common conditions will be treated more and more with cheaper generic drugs.
For policy-makers, the move toward generics means drug therapies will become cheaper, which will go a long way toward making health care overall cheaper. For that reason, it behooves them and healthcare providers (ranging from physicians to pharmacists) to make sure patients know when a generic drug for their condition is available so that neither they nor their payers have to spend an arm and a leg to keep them healthy.
This is what makes the reauthorization of the Prescription Drug User Fee Act, signed by President Barack Obama last month, especially timely. One major goal of the reauthorization is to clear the backlog of about 2,500 generic drug applications currently held up at the Food and Drug Administration due to insufficient staff and resources to review them. This will help make generic drug approvals happen faster and more efficiently and ensure that generics get into the hands of patients sooner.
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Craig Gourley joins Shopko
GREEN BAY, Wis. — Shopko announced that a former JCPenney executive has joined the company.
Shopko said Craig Gourley will serve as its new SVP and general merchandise manager of home and hardlines. Gourley will be responsible for overseeing all aspects of merchandising for the home division, including developing strategies, negotiation of vendor partnerships and managing the buying team. He will report to EVP and chief merchandising officer Jill Soltau.
Gourley joins Shopko after five years at JCPenney where he served as divisional VP/divisional merchandise manager, managing 60% of JCP’s home business.
"Craig brings strong leadership and extensive experience to our home division at a critical time as we expand our brand to new customers in our Shopko Hometown markets. Throughout his career, Craig has consistently delivered exceptional financial results due to his focus on newness, key items, total brand development and superior planning strategies," Soltau said. "He has a reputation for being a skilled negotiator with both domestic and import vendors and an effective leader and manager. His proven track record of success, coupled with his experience and fresh perspective, will make him a strong addition to our team."
CDC: Additional cases of flu strain infection reported
ATLANTA — The Centers for Disease Control and Prevention on Friday reported 12 additional human infections with influenza A (H3N2) variant virus in three states, comprising of one case in Hawaii, 10 cases in Ohio and one case in Indiana. The H3N2v virus contains the M gene from the 2009 H1N1 virus, as have the previous 17 cases detected since July 2011.
According to the U.S. Department of Agriculture, swine influenza surveillance, this swine H3N2 virus with the pandemic M gene has been detected in swine in a number of U.S. states. This virus may be circulating widely in U.S. swine at this time. It should be noted, however, that influenza viruses have not been shown to be transmissible to people through eating properly handled and prepared pork (pig meat) or other products derived from pigs.
All of this week’s reported cases occurred in people who had direct or indirect contact with swine prior to their illness. The 10 cases in Ohio were associated with attendance at a fair where reportedly ill swine were present. The H3N2v case reported by Indiana also occurred in a person who attended a fair where swine were present. The CDC continues to recommend preventive actions people can take to make their fair experience a safe and healthy one.
The number of cases of infection with H3N2v viruses with the M gene from the 2009 H1N1 virus detected in the United States since July 2011 now totals 29: Hawaii (1); Indiana (7); Iowa (3); Ohio (10); Maine (2); Pennsylvania (3); Utah (1) and West Virginia (2). According to the CDC, 23 of these cases reported swine contact prior to illness onset. Among those 29 cases, 19 cases were associated with fairs where swine were present. Most human illness with H3N2v virus infection has resulted in signs and symptoms of influenza (i.e., fever, cough, runny nose, sore throat, muscle aches) and three hospitalizations have occurred. All of the people hospitalized had high risk conditions, defined as children younger than 5 years old, seniors older than 65 years of age, pregnant women and people with chronic medical conditions (i.e., asthma, diabetes, heart disease, etc.). The CDC advised that people in these high-risk groups should avoid exposure to pigs and swine barns this summer. All H3N2v virus cases have recovered fully.
It is possible that acquisition of the M gene from the 2009 H1N1 virus may allow H3N2v viruses to be more transmissible from pigs to people and from person-to-person, the CDC cautioned. Late summer is typically fair season across the United States and fairs are a setting that can provide many opportunities for exposures to occur between pigs and people. The CDC continues to advise people to take recommended precautions when interacting with pigs or their environments, including frequent hand washing and avoiding contact with pigs that appear ill.
Studies conducted by the CDC have indicated that children younger than 10 years old would have little to no immunity against H3N2v virus, whereas adults may have some cross-protective immunity. Most cases of H3N2v have occurred in children at this time.