‘Skinny labels’ on generics can save patients money, research shows, but recent court decisions cloud future
New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.
Aaron KesselheimWhile courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.
“Teva was a problematic decision because it made it harder for generic companies to do what they’re legally allowed to do,” Harvard medical professor Aaron Kesselheim told Endpoints News.
Kesselheim and colleagues at Harvard’s Program On Regulation, Therapeutics, And Law published a paper on Tuesday in the Journal of Clinical Oncology that looks into how the skinny label for generic versions of the cancer drug Gleevec worked.
What they found was that generic versions of Gleevec were dispensed frequently for indications that were both included and excluded from the skinny labeling, although patients with one of the excluded indications were “slightly less likely to receive a generic version.”
Those on the generic saved money.
“We found that out-of-pocket costs for brand-name imatinib far exceeded such costs for generics for patients with certain types of insurance, although we were unable to account for coupons or patient assistance programs that might offset these out-of-pocket costs for some patients,” the researchers wrote.
They also called on Congress to create an exemption to shield physicians and pharmacists from legal liability for writing prescriptions for generics or substituting generics in place of brand-name drugs in cases when one or more indications are carved out of the generic labeling.
Bryan Walsh“Congress has created a similar exception for medical or surgical procedure patents that allowed the issuance of patents for such procedures or techniques, but shielded physicians and related health care entities from liability for patent infringement,” they wrote.
Co-author of the paper Bryan Walsh also told Endpoints that there is added uncertainty from the recent Amarin v. Hikma opinion, where a court threw out a challenge to the skinny label on a fish oil drug.
“The court, in this case, sided with the generic company in dismissing Amarin’s lawsuit – yet the facts were extremely similar to those presented in the GSK v. Teva case. Ultimately it will be up to the lower courts to determine how (or if) the GSK v. Teva should be factored into future lawsuits, creating more uncertainty for generics looking to develop skinny label generic versions of brand-name drugs,” Walsh said.
And while the Federal Circuit’s majority said in its opinion that its “narrow, case-specific review of substantial evidence does not upset the careful balance struck by the Hatch-Waxman Act” regarding label carve-outs, concerns remain around the uncertainty of these skinny labels.
“Skinny-labeled generics can provide substantial savings for patients and the health care system by helping circumvent a common generic-delaying practice used by brand-name manufacturers,” the authors concluded.
