Using what some observers might describe as systemic loopholes, Abbott Laboratories used lawsuits and minor reformulations of TriCor to hold off generic competition to its cholesterol- and triglyceride-lowering drug. We recently wrote about Eisai and Pfizer pulling the same stunt with its Alzheimer’s drug, Aricept.
The study, published in the Archives of Internal Medicine, estimated that the prolonged exclusivity of brand-name formulations of fenofibrate cost the U.S. health-care system approximately $700 million per year.
Sometimes, drug companies pay off potential competitors to buy extra time for their brands. That cost to consumers also is considerable.
As reported on MedPage Today, generic versions of fenofibrate have been available for more than a decade. When the generic product was developed, Abbott sued, alleging patent infringement. Such lawsuits, per FDA rules, require a 30-month delay in approval of the generic.
The interlude enabled Abbott to reformulate TriCor by slightly revising its dose and presenting the re-branded “Trilipix” (fenofibric acid) to the FDA as bio-equivalent to the original version. By the time Abbott had Trilipix on the market, pharmacists, by law, were unable to substitute a generic because of the dosing difference. Brand-name sales tripled from 2002 to 2009.
The researchers said that Abbott had used the delay tactics twice to protect TriCor from generic competition, and that the company had presented clinical trial results indicating that the reformulations were not more effective or safer. So in addition to higher expense, patients get the short end of this corporate-shenanigans stick for its diminished therapeutic value.
Last year, the FDA required Abbott to relabel Trilipix to reflect the trial results. The agency also ordered that a new clinical trial be conducted.
An editorial accompanying the research study acknowledged that Abbott’s gaming of the system was “perfectly legal,” but that the real news is that the company’s methods “”exposed many patients to a drug with high costs, known risks and little or no clinical benefit.”
In addition to the always-possible allergic reaction, TriCor’s risks include rare but severe muscle or joint pain, headache, nausea, chest and stomach pain, confusion, irregular heartbeat, persistent sore throat, coughing up blood, skin problems, dizziness or lightheadedness, shortness of breath and unusual bruising or bleeding.
As readers of this blog know, Abbott is hardly alone in putting its financial interests ahead of medical need. To remedy the situation of Big Pharma fending off competition at significant cost to patients, the researchers suggest:
- allowing pharmacists to substitute bio-equivalent generic drugs, even if the dosing is different;
- requiring companies to seek approval for a dosing change to settle any patent infringement suits before approval, which would allow the generic and the new brand-name version to compete immediately;
- requiring companies to market such reformulations under different brand names.
If your doctor prescribes a brand-name drug, ask if there’s a generic equivalent. If there is, ask why he or she believes the brand name version to be superior. If you’re not satisfied with the answers, request the generic.