Backlog of generic drug applications at FDA

BY Richard Monks

Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.

(For the full chain pharmacy section of DSN's Aug. 25 issue, click here.)

“They are buried,” Robert Pollock, a former acting deputy director of the OGD, told the Wall Street Journal earlier this month.

“They are on track to receive more than 1,500 [applications] this fiscal year,” he said. “The estimates were for between 800 and 850 applications, and the funding was based on assumptions of a workload that were far below what they are seeing. I believe that OGD needs to change the way it reviews applications.”

Pollock, who is now with Lachman Consultants, where he advises generic drug makers on regulatory issues, said the FDA needs to find ways to boost staffing even as it faces budgetary constraints.

Two years ago, the agency was authorized to start collecting fees from generic drug makers in order to increase the number of facility inspections — especially those overseas — and speed up application reviews in order to ensure safety and bring new generics to market faster.

This summer, however, the FDA has seen an unexpected number of applications that have not been processed. Regulators say the situation was created partly by a deadline for submitting applications that reflected required changes in testing medicines.

However, some in the industry contend that the backlog is due to a more fundamental problem, as the FDA struggles to deal with a growing amount of paperwork.

Pollack said he feels OGD’s problems could worsen if the number of applications from companies based in China starts to accelerate. Any further slowdown in approvals, he said, could result in generic drug makers and the FDA sparring over the next round of fees that are used to fund the program.

The number of generic drugs approved by the FDA has been relatively stable over the past few years. In fiscal 2010, the agency approved 426 medicines. A year later, the total hit 458, and the number of approval topped out at 517 in fiscal 2012. Last year, the FDA approved 330 generics.

The number of applications received, however, has not kept pace with the approval rate. The FDA said that in the current fiscal year, it already has received 1,440 approval requests, including 600 in July alone.

While not causing any disruptions in the market so far, some have suggested that further approval delays could adversely impact efforts to control healthcare spending.

According to the IMS Institute for Healthcare Informatics, 86% of all prescriptions in the United States last year were for generics.


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Focusing clinical collaboration on prevention

BY Jim Frederick

“It’s not enough to pull drowning victims out of the river. You have to walk upstream to find out who’s throwing them in.”

Physician and educator David Kilgore invoked that piece of wisdom from Episcopal bishop V. Gene Robinson to describe the current state of medicine in the United States — and the steps needed to drag the nation’s outmoded, costly and inefficient healthcare system into the 21st century. For doctors and other health providers, Kilgore noted in a panel discussion at the New York Times “Health for Tomorrow” conference, “walking upstream” means changing the focus of care from treating serious health complications after they occur to preventing them in the first place whenever possible.

(For the full chain pharmacy section of DSN's Aug. 25 issue, click here.)

“We’re still stuck in the model from the first transformation of medicine, which did a great job with infectious disease, acute illness and injuries. But it’s not an effective model for chronic disease,” said Kilgore, clinical professor of family medicine at the University of California School of Medicine. “The river is full of drowning people, and we’re going to need a lot more than drugs or devices to usher in the second transformation of medicine.”

That transformation, he said, “has to … focus on prevention, health and wellness.”

“We have more than two decades of research that clearly shows what keeps us healthy and what prevents chronic disease,” Kilgore said in a group presentation on the future of the doctor-patient relationship. “It’s the four foundational pillars of health: healthy diet and nutrition; exercise and activity; [attention to] mind/body [living conditions], including social support; and healthful sleep.”

Those factors, along with “toxin avoidance,” Kilgore said, are critical to long-term wellness. “These are powerful interventions that keep us alive longer, that help us have less disability and suffering for a lower-cost, greater-quality of life and less side effects. So the challenge for us as a profession and a society is how to move that second transformation … into [community outpatient settings like] clinics, so that the primary care physician, instead of rushing from room to room … is replaced by a new kind of healthcare team that surrounds and is part of that physician’s practice.”

That collaborative team of professionals, including nurses, pharmacists, clinic staff and nutritionists, Kilgore said, “then helps patients develop healthy lifestyle skills, self-management skills and self-efficacy.”

Driving the acute need for fundamental transformation in healthcare delivery, he added, is the fact that “in just the last 20 years, there’s just been an explosion of chronic disease. The incidence of diabetes has more than tripled. Sixty-eight percent of U.S. adults are now overweight or obese.”

“It’s a tsunami of diabetes and chronic disease,” Kilgore said. “And it’s completely changed what it means to be a family physician on the front lines. It very much seems like a ‘sick care’ system.”

Indeed, Kilgore said, “out of the $2.7 trillion [U.S. healthcare] budget, just 5% is spent on prevention and public health. We need to think about moving the whole enterprise upstream, targeting people even before they have that chronic disease. That means bringing tools for health and wellness to the workplace … to schools, to community centers. It’s really incumbent on us to make sure patients have the tools they need for a healthy lifestyle.”

Other panelists agreed. “Despite lifestyle behaviors being primary contributors to most chronic diseases — which according to the CDC, are consuming at least 70% of our healthcare dollars — we don’t have a practice model that leads to achievable or sustainable behavior change,” said Karen Lawson, a physician who directs health coaching at the Center for Spirituality and Healing.

“I think there’s a missing provider … who partners in a relationship-centered, client-driven process to facilitate and empower patients to achieve the health beliefs and behavior changes that they want,” Lawson said. “We call that person a health coach … who applies their knowledge and skills to assist clients to mobilize their own internal strengths, to access their best external resources and to make the changes they want to make to optimize their well-being.”


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As care shifts to community wellness, costs will ease, hospital leader predicts

BY Jim Frederick

Pharmacists aren’t the only professionals grappling with the uncertainties of health reform, shifting patient-care delivery models and changing reimbursement standards. Doctors also are trying to redefine their health mission, patient relationships and practice priorities, said Toby Cosgrove, M.D., the top executive at Cleveland Clinic, one of the nation’s premier healthcare organizations.

(For the full chain pharmacy section of DSN's Aug. 25 issue, click here.)

A decade from now, the U.S. healthcare system “is going to be very different,” said Cosgrove, president and CEO of Cleveland Clinic.

“I think … we’re dealing with probably the biggest social change going on in the United States since the New Deal,” Cosgrove said in a presentation on the future of health care at the “Health for Tomorrow” summit. “It affects 100% of the people and 18% of the GDP. And it’s changing a business that’s gone from B-to-B to B-to-C. So there’s going to be enormous change, and as a profession and an industry, we’re having slow adoption of this, and difficulty moving through it.”

Hampering the medical profession’s embrace of change, Cosgrove said, is the disruption that comes with it. “When we got into medical school, our career was pretty much fixed. Now, it’s very different. We don’t know what we’re going to get paid, what we’re going to get paid for or where we’re going to practice,” he said. “And we don’t know what kind of medicine we’re going to be practicing.”

“We’re going through a very interesting period,” Cosgrove said. “It’s a tough transition.”

Even well before the onset of the Affordable Care Act and health reform, mounting cost concerns were driving big changes in U.S. healthcare delivery, he said. “Twenty years ago, there were a million hospital beds in the United States. Now there are 800,000, and it’s 65% occupancy,” Cosgrove said. “You’re going to see a consolidation, a closure of hospitals and a reduction in hospital beds as more and more things move out of the hospital.”

Where have those patients gone? For one thing, they’re shifting to outpatient care sites like clinics and pharmacies staffed by clinically oriented pharmacists who can deal with patients with chronic conditions. They’re also being transferred out of the hospital and into the community care setting and their own homes much more quickly following most surgeries, Cosgrove said. Nowadays, “people don’t get hospitalized for chronic disease until they reach desperate straits; that’s taken care of by outpatient [settings].”

What’s more, he added, many surgeries like knee reconstruction, mastectomies and thyroidectomies are now being done on almost an outpatient basis, involving just one- or two-night stays.

“That is going to decrease demand for hospitals,” he said.

Cosgrove was joined onstage by physician and New York Times senior writer Elisabeth Rosenthal, who posed a question that was never far from the surface at the daylong summit. Given that drop in demand, she asked Cosgrove, “as we close hospitals and move patients to an outpatient setting, why aren’t there more cost savings?”

One big reason, Cosgrove said, is cost shifting. As health systems lowered prices on procedures within their hospitals to compete more effectively for insurer reimbursements, they raised prices for outpatient care. “The costs just got moved from one place to another,” he said.

Cosgrove offered some solutions to this ever-rising cost spiral. “We recognize we have too costly a healthcare delivery system. There are only two ways we can take costs out of it. One is by having a more efficient delivery system. And the second is by having less disease … if we kept people healthy.”

To that end, Cleveland Clinic adopted a sweeping set of initiatives aimed at making its own 43,000 employees healthier. “We started by taking steps to try to prevent disease,” he said, by addressing “smoking, lack of exercise and obesity or food intake.”

The health system, which is Cleveland’s largest employer, began by adopting a no-smoking policy on its own campuses, and by offering free smoking-cessation programs and nicotine patches not only to its own employees, but also to all residents of Cuyahoga County. “Then we took a bold step; we said we’re not going to hire smokers anymore.”

In addition, Cleveland Clinic pushed the Ohio Board of Regents to ban smoking from all public universities in the state. The result was a reduction in smoking in Cuyahoga County over a five-year period, from 27% of residents to 15%. “And the incidence of smoking among employees of Cleveland Clinic is [now] 6%,” Cosgrove said.

The clinic also overhauled the menus in its own cafeterias, removing unhealthy offerings and even candy machines. It also began offering all employees free access to its on-campus fitness centers, as well as free pedometers and weight-reduction programs. “Over the last five years, we’ve [collectively] lost 450,000 lbs.,” Cosgrove said.

The clinic also began providing its employees with financial incentives to enter into disease management programs for such conditions as diabetes, hypertension, smoking, obesity and asthma.

“We saw a reduction in hospitalizations [for some of those conditions] of 20%,” Cosgrove said.

Another challenge to capping health costs and improving Americans’ health, however, is the lack of continuity in insurance coverage and care. As patients move around and frequently switch insurance plans, “no one [is] investing in [patients’] long-term disease state,” Rosenthal said.

Dealing effectively with that challenge, Cosgrove said, “is a societal issue” that “is going require educators, physicians, universities, government, food producers, food servers — all beginning to realize that it’s in their best interest to deal with this issue. It’s going to take a big national discussion.”

He predicted that the health system would undergo “the disintermediation of hospitals,” adding, “I think you’re going to see lab tests going to Walmart or Walgreens and radiology leaving the hospital. It’s going to be like a department store, and that will increase the efficiency and decrease the costs.” And price, he said, will drive many choices in sites of care.

Health care, in short, is evolving into “a consumer-driven organization … with transparency around costs” that’s driving a more competitive and efficient health system, Cosgrove said.



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