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Published Online: Monday, July 11, 2011   [ Request Print ]

Supreme Court Sides With Generic Drug Makers

The US Supreme Court decided in June that generic drug makers cannot be sued for failing to update drug warning labels with information about newly identified risks. Allowing such lawsuits would violate a federal law that requires the labels of generic drugs to be identical to their brandname counterparts, the court ruled.

The decision involved cases filed by 2 patients who sued generic manufacturers over side effects caused by metoclopramide, a generic version of Reglan. As a result of long-term use of the drug, both patients had developed tardive dyskinesia, an irreversible neurological disorder that was not listed on warning labels.

If the generic makers had updated the labels to warn of the risk of tardive dyskinesia, they would have done so in violation of federal law. Justice Sonia Sotomayor, who voted against the ruling, said the decision “makes little sense,” and gives patients who receive generic drugs no recourse in the event of a serious, unanticipated side effect, National Public Radio reported.

The Generic Pharmaceutical Association (GPhA) supported the outcome, noting the discrepancy between state and federal law. Allowing the suits to proceed would have put manufacturers in the “impossible position of defending the content of a label that they are required by law to use but prevented by law from changing,” said GPhA Executive Director Bob Billings.

$4 Generics a Mixed Blessing for Patients

When big-box retailers slashed the price of generic drugs to $4 for a 30-day supply in 2008, many worried the marketing move would increase overall prescription costs. Now, a group of researchers says their concerns have merit, calling the programs “a mixed blessing” for patients with diabetes.

The study, presented June 26, 2011, at the annual meeting of the American Diabetes Association, found that at the same time stores were introducing low-cost generic formularies, they were also gouging prices for branded versions of the drugs, leading to an increase in overall expenditures at those stores.

“The accelerated price increase for branded medications has offset any savings offered by discounted generic plans,” noted lead study author Ronald Tamler, MD, PhD, MBA, of the Mount Sinai School of Medicine. He and colleagues advise patients with diabetes to use the findings of the study to shop around for the best price.

According to the report, price hikes for the 10 most-prescribed branded diabetes drugs occurred across the board from 2008 to 2010, but especially at Walmart and Kmart, where prices increased by 32% and 35%, respectively. By comparison, chain drugstores, mail-order pharmacies, and independent pharmacies increased prices just 21%.

Despite these findings, researchers say the $4 discount programs have been favorable for patients, lowering the average cost of a 30-day supply of generic diabetes drugs by 60%. For value-conscious patients, the new pricing landscape has other benefits as well, the authors noted.

Because nearly all pharmacies now offer some version of the $4 formulary, comparison shoppers can “focus on less quantifiable attributes, such as long-standing relationships with their local pharmacist or convenience of purchase instead of price alone,” they wrote.

Cancer Meds or Groceries? Costs Force Patients to Choose

On top of the physical and emotional hardships of cancer, new research shows many patients who have the disease are just scraping by financially. According to a study presented in June at the 2011 American Society of Clinical Oncology Annual Meeting, even patients with insurance avoid filling their prescriptions, skip or ration doses, or forgo food and other essentials in order to afford treatment.

Their sacrifices illustrate the often overlooked “financial toxicity” of cancer, said senior author Amy Abernethy, MD, an associate professor in the division of medical oncology at Duke University School of Medicine. “We used to think about chemotherapy toxicity in terms of bad side effects,” such as vomiting or pain, she said. “Now we are starting to think in terms of how treatment choices impact real aspects of daily living.”

In the study of 216 patients who sought financial assistance at the HealthWell Foundation, out-of-pocket expenses averaged $712 a month—a “significant burden” to 30% of study participants and a “catastrophic problem” to 10% of participants. Whether these hardships undermined clinical outcomes remains unclear, but reports of rationing medications and neglecting to fill prescriptions were frequent, the authors noted. PT 





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