Court OKs suit vs. branded firms over side effects of generic drugs
Alabama’s Supreme Court ruled in January that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports. According to the New York Times, an Alabama man named Danny Weeks claimed he developed tardive dyskinesia after taking generic versions of Pfizer’s acid reflux drug Reglan (metoclopramide). Pfizer acquired rights to the drug when it bought Wyeth in 2009, and generic drug makers Teva and Actavis, now owned by Watson, make generic versions.
Weeks had originally filed the suit in federal court, but the court asked the Alabama Supreme Court to determine if Weeks could sue the branded drug makers.
Under Food and Drug Administration regulations, generic versions of branded drugs must use the same safety labeling as the branded versions, and the Times noted that a 2011 Supreme Court decision, Pliva v. Mensing, determined that generic drug companies had no control over what drug labels said, meaning they could be sued for failing to inform patients of safety risks.
Canadian provinces to cut generic payments
Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country’s provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.
Quebec did not take part; that province announced in November 2012 the elimination of its "15-year rule," a rule unique to the province that required its prescription drug plan to reimburse the price of the original drug even after patent expiration had made cheaper generics available. Currently, provinces pay between 25% and 40% of the cost of branded drugs for six key generics, but under the deal, they will pay 18% starting in April.
The drugs are the generic versions of Pfizer’s cholesterol drug Lipitor (atorvastatin); King Pharmaceuticals’ blood pressure drug Altace (ramipril); Pfizer’s antidepressant Effexor (venlafaxine); Pfizer’s angina drug Norvasc (amlodipine); AstraZeneca’s gastroesophageal reflux disease drug Prilosec (omeprazole); and Eisai and Johnson & Johnson’s GERD drug Aciphex (rabeprazole).
While praising a decision by the provincial governments not to pursue a plan to tender for generic drugs, the Canadian Generic Pharmaceutical Association was displeased with the reimbursement reduction.
"CGPA is pleased that provincial governments have decided not to proceed with tendering for generic pharmaceutical products. Tendering for generic drugs could result in drug shortages and delayed savings to Canada’s healthcare system." CGPA president Jim Keon said. "We are, however, disappointed by the provincial governments’ announcement of further cuts to retail or reimbursed prices for generic prescription medicines."
While generics account for 80% of dispensed prescriptions in the United States, the equivalent rate in Canada is more than 60%, according to IMS Health.
Survey: Many doctors ignore generic savings
Are doctors needlessly raising the costs of America’s healthcare system through their prescribing habits? Absolutely, say researchers. A new report appearing in the Jan. 7 issue of JAMA Internal Medicine highlighted the powerful role played by branded drug advertising on consumer preferences and physicians’ prescribing habits, and asserted that many doctors ignore the cost-saving benefits of generic drugs when writing prescriptions by acceding to patients’ wishes.
"Approximately 4-of-10 physicians report that they sometimes or often prescribe a brand-name drug to a patient when a generic is available because the patient wanted it," researchers reported in JAMA. "These numbers suggest that the unnecessary costs associated with this practice to the healthcare system could be substantial."
The JAMA report is based on a survey — conducted by the Harvard Medical School and the Colorado School of Public Health — of 1,891 randomly sampled prescribing physicians practicing in seven medical specialties. Approximately 37% of the doctors surveyed told researchers that in many cases they prescribe a specific branded drug the patient asks for, rather than an available generic alternative, despite the higher costs involved.
Advertising by pharmaceutical companies prompts many patients to pressure their doctors for the brand-name prescription drug, the report suggested. "Prescribing brand-name drugs when generic drugs are available generates unnecessary medical expenditures, the costs of which are borne by the public in the form of higher co-payments, increased health insurance costs and higher Medicare and Medicaid expenses," the report noted.
The result is "is a huge source of wasteful spending that can be prevented," wrote Eric Campbell, professor of medicine at Harvard Medical School and team leader of the study. Researchers found that older physicians are more likely to acquiesce to their patients’ requests for the branded medicine. The survey, the authors noted, "shows that 43% of physicians in practice more than 30 years sometimes or often give in to patients’ demands for brand-name drugs compared with 31% physicians in practice for 10 years or less."
In addition, doctors "working primarily in sole or two-person practices were significantly more likely to acquiesce to patient demands than those working in a hospital or medical school setting [46% vs. 35%]," JAMA reported. But pediatricians, anesthesiologists, cardiologists and general surgeons "were significantly less likely to acquiesce patient demands relative to internal medicine physicians."
The Generic Pharmaceutical Association was quick to seize on the survey findings. "The JAMA Internal Medicine study demonstrates that we are still leaving savings on the table that could be achieved by increasing the use of generic drugs," GPhA president and CEO Ralph Neas asserted.