PHARMACY

Senators to FDA: Stop delaying generic drug approvals

BY Allison Cerra

WASHINGTON — Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans’ access to affordable medications by avoiding the delay of generic drug approvals.

The letter — sent by Sens. Tom Harkin, D-Iowa, who serves as chairman of the Senate’s Health, Education, Labor and Pensions committee; Jay Rockefeller, D-W.Va.; Charles Schumer, D-N.Y.; Debbie Stabenow, D-Mich.; and Sherrod Brown, D-Ohio — urged Hamburg to approve generic versions of certain "blockbuster" drugs, as "it is estimated also that the public could save more than $3.97 billion to $6.7 billion a year upon generic entry, which equates to $10.9 million to $18.3 million a day in potential savings," the senators wrote.

The senators specifically highlighted Lipitor (atorvastatin), the popular cholesterol treatment made by Pfizer. "Although generic versions of Lipitor may be eligible for approval [as early as June 28], we are concerned that current regulatory circumstances could significantly delay entry of new generic products into the marketplace," they wrote. "We are eager to avoid such delays because each year, it is estimated that the government alone spends $2.54 billion on Lipitor through Medicaid, Medicare Part D and Veteran’s Affairs expenditures."

The senators hoped to receive a response from Hamburg and the FDA this week.

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Study: $4 generic programs could help save society close to $6 billion

BY Allison Cerra

PITTSBURGH — Patients that opt to fill their prescriptions through a $4 generic program could help garner societal savings of nearly $6 billion, a new study found.

Conducted by the University of Pittsburgh Graduate School of Public Health and published in the March 14 issue of the Archives of Internal Medicine, the study examined a nationally representative sample of nearly 31,000 people in the "2007 Medical Expenditure Panel Survey" and identified patients who could have saved money had they filled their medications through a discount generic drug program.

After comparing those who used generic medications or their brand-name counterparts for such drugs as lovastatin or prescription-strength ibuprofen, GSPH researchers found that less than 6% used the $4 generic medication programs in 2007 — although average prescription drug coverage plans asked patients to pay about $10 per 30-day supply for generic drugs and about $25 per 30-day supply for brand-name medications — and noted that if all eligible patients had used the discount programs in 2007, the societal savings would have been $5.8 billion.

"Although just half of the potential users of the $4 programs would have saved more than $22 a year in out-of-pocket expenses, the societal savings are great. This suggests the majority of savings comes from a small proportion of individuals," said the study’s lead author, Yuting Zhang, assistant professor of health policy and management at GSPH.

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Study: Metformin best first-line diabetes treatment

BY Allison Cerra

NEW YORK — While several drugs to treat Type 2 diabetes are on the market, researchers have found that the best first-line option is metformin.

Led by Wendy Bennett, an assistant professor of medicine at Johns Hopkins University School of Medicine in Baltimore, researchers reviewed 140 trials and 26 observational studies of head-to-head comparisons of monotherapy or combination therapy that reported intermediate or long-term clinical outcomes or harms of six oral diabetes medications.

Despite the fact that all of the drugs — metformin, second-generation sulfonylureas, thiazolidinediones, meglitinides, dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists — reduced hemoglobin A1C levels as either a monotherapy or combination therapy, metformin proved to be the most efficacious for posing the least amount of risks.

The other treatments, study authors noted, posed a higher risk of such conditions as hypoglycemia, congestive heart failure and bone fractures.

"Metformin continues to be an inexpensive medication, and it’s very efficacious," Bennett said.

The study was published in the Annals of Internal Medicine.

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