Morning Briefing
Summaries of health policy coverage from major news organizations
Patents Taking A Leading Role In War Against High Drug Prices
A Republican senator wants to clamp down on drug companies that use multiple patents to extend their monopolies, colloquially known as "patent thickets. "Sen. John Cornyn (R-Texas) plans to introduce a bill soon that would give the Federal Trade Commission authority to sue drugmakers that game the patent system or "product hop" by making minor formula adjustments to prevent generic substitutions. (Luthi, 4/25)
You can add Amgen (AMGN) and Astellas Pharma (ALPMY) to the growing list of drug makers that have finalized agreements with federal authorities over accusations that donations paid to charities actually were kickbacks to Medicare patients as a way to cover their out-of-pocket costs. A federal law known as the Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration 鈥 which includes money or anything else of value 鈥 to induce Medicare or other federal programs to purchase their drugs. (Silverman, 4/25)
Amgen Inc. and Astellas Pharma Inc.鈥檚 U.S. unit have agreed to pay a total of $125 million to resolve kickback allegations that they violated federal law by using charities to pay for Medicare patients鈥 out-of-pocket costs for the companies鈥 own drugs, federal prosecutors said. The two separate settlements are part of a long-running Justice Department investigation into the financial support drug companies provide to charities that help patients pay for prescription drugs. (Chin, 4/25)
In policy debates, patient charities are much more effective advocates than pharma companies, whose reputations have suffered amid soaring drug prices, said Matthew McCoy, a professor of medical ethics at the University of Pennsylvania. 鈥淲hen drug companies give money to patient groups, it鈥檚 not out of pure altruism,鈥 he said. 鈥淭hey鈥檙e hoping to get something in return.鈥 (Elgin, 4/26)
Sanofi upheld a long-awaited return to growth on Friday with higher profits and revenues for the first quarter, once again led by a stellar sales increase at its rare diseases Genzyme unit. The French drugmaker, which also posted a strong performance at its vaccines division and a new slide in diabetes confirmed its full-year outlook. Pressure on pricing for high cholesterol treatment Praluent was expected to continue this year in the United States, chief financial officer Jean-Baptiste de Chatillon, told reporters. (4/26)
Recent laws in several states that protect drugmakers鈥 contributions toward patients鈥 prescription copays are highlighting an escalating battle in the larger war on drug pricing. In the past month, Arizona, Virginia and West Virginia became the first states to enact laws restricting insurance companies from excluding most drug manufacturer coupons or other financial assistance from a patient鈥檚 cost-sharing responsibilities. Similar bills are pending in a host of other states, including Connecticut, Illinois, Indiana, Kentucky and North Carolina. (Clason, 4/26)
California regularly portrays itself as a national trendsetter on political issues, and Gov. Gavin Newsom is claiming that title on prescription drugs. Newsom has a plan to take on the drug industry, and at an April 17 news conference in Southern California, he declared that two other governors already want to join his effort.鈥淐alifornia is leading the nation in holding drug companies accountable and fighting prescription drug prices,鈥 Newsom said via a press release that day, marking his 100th full day in office. (Young, 4/26)