Consumer advocacy group urges FDA rejection of prasugrel
WASHINGTON A researcher who helped develop a drug designed to reduce heart attacks now wants the Food and Drug Administration to reject it.
Working with the consumer advocacy group Public Citizen, Victor Serebruany has sent a letter to FDA commissioner Margaret Hamburg urging the agency not to approve Eli Lilly & Co.’s and Daiichi Sankyo’s drug prasugrel. Serebruany holds a patent application for the drug and sold commercial licensing rights for it to Lilly.
Serebruany cited “serious flaws” in the TRITON-TIMI 38 phase 3 trial of the drug comparing it to Plavix (clopidogrel), by Sanofi-Aventis and Bristol-Myers Squibb. Serebruany said “incorrect” and “unsafe” doses of prasugrel were given to patients and that the drug may act as a “cancer promoter” because of its antiplatelet activity.
“An earlier clinical study showed that a 10 milligram daily dose of prasugrel was far too potent, and I raised concerns that it might result in an increased bleeding risk,” Serebruany said. “This is exactly what was seen in the TRITON-TIMI 38 study. Considering that bleeding rates grow over time, the effects of this drug could be even worse in real-life scenarios.”
A Lilly spokeswoman told Drug Store News that Serebruany voiced the same concerns as a public speaker at a meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, but that the committee voted unanimously that the FDA should approve the drug.
“In response to Public Citizens letter to the FDA, Daiichi Sankyo Inc. and Eli Lilly & Co. remain confident in the overall benefit-risk profile of prasugrel and stand behind the clinical trial design and results from the TRITON-TIMI 38 clinical trial,” the spokeswoman said. “TRITON-TIMI 38 was a head-to-head trial that the TIMI Study Group at Harvard Medical School designed as well as conducted, and the analysis of the trial was rigorous and met the standards of regulatory authorities.”
NCPA appealing AWP pricing settlement
ALEXANDRIA, Va. Stoking a long-simmering dispute over drug payments by health plan sponsors to pharmacies, the nation’s largest independent pharmacy group is appealing a lower court’s settlement of a lawsuit that would reduce the published average wholesale price figures used in pharmacy reimbursement contracts.
If the settlement is not overturned, said the National Community Pharmacists Association, the resulting cutbacks in pharmacy payment rates on many drugs could be devastating to community pharmacies. In response, NCPA said Wednesday it has filed an appeal with the First U.S. Circuit Court of Appeals.
The appeal seeks to freeze AWP-based payment rates to pharmacies at their current levels until the federal court has reviewed the mid-March settlement.
The original case revolved around the prices that union pension funds, teachers’ unions and other health plan sponsors were paying pharmacies to dispense drugs to their members. Historically, reimbursement rates have been based on the drug’s AWP. But the plan payers acting as plaintiffs in the original case charged in U.S. District Court that drug-price publishers had allowed those rates to rise to unrealistic levels, leading them to pay a 25% premium over AWP for some 8,000 drugs dispensed to their plan members.
Originally named in the health plans’ suit was First DataBank, which was accused of conspiring with McKesson Corp. to set AWP rates artificially high. But in May 2007, Medi-Span, a division of Wolters Kluwer Health, was named as a defendant in a similar class action involving the publication of AWPs.
“The groups alleged that the two publishers and the wholesalers illegally conspired to inflate the markup between Wholesale Acquisition Cost and AWP from 1.20 to 1.25. This resulted in higher costs to patients and third party payers,” NCPA noted in a statement.
Three years ago, the independent pharmacy group joined the National Association of Chain Drug Stores and the Food Marketing Institute in opposing a proposed settlement that would have rolled back the increase on those 8,000 drugs. That intervention, noted NCPA, “resulted in a $291 per day saving for every community pharmacy when U.S. District Court Judge Patti B. Saris rejected that settlement, savings that continue.”
In January 2008, the judge agreed with NCPA that the rollbacks on the 8,000 brand name drugs would be devastating to community pharmacy. Earlier this year, she pared the list to about 1,400 drugs to be reimbursed at lower rates, and extended the effective date from three months to six months after the settlement, as NCPA requested. “However,” the pharmacy group noted today, “even the reduced list will cause major reductions in Medicaid payments and a 4% cut in AWP-based reimbursements for pharmacies unable to renegotiate their PBM contracts by Sept. 26.”
Mylan COO says Congress must ‘look further into use, abuse of authorized generics’
PITTSBURGH An executive from generic drug maker Mylan said in testimony before Congress Wednesday that “authorized generics” launched by brand drug makers during a generic company’s customary six months of market exclusivity undermine competition.
Testifying before the House Judiciary Subcommittee on Courts and Competition Policy, Mylan COO Heather Bresch also said authorized generics – branded drugs that brand companies release under their generic names, often through third-party companies – delay access to generic medications for patients, taxpayers, government agencies and businesses.
“When it comes to settlements, Congress need look no further than the use and abuse of authorized generics by brand manufacturers,” Bresch said in the hearing, which the subcommittee convened to debate so-called “pay-to-delay” agreements between brand and generic drug companies. “The increase in the number of patient litigation settlements in recent years is directly related to the increased use of authorized generics during the 180-day market exclusivity period.”