Morning Briefing
Summaries of health policy coverage from major news organizations
Government May Reexamine Safe Harbor That Drug Rebates Have Under Antikickback Laws
Bloomberg: FDA Chief Floats Rethinking Of Laws Allowing Drug-Plan Rebates
Days ahead of the expected rollout of a White House plan to tackle soaring drug prices, a top U.S. health official asked whether the legal status of drug-plan rebates should get another look. Food and Drug Administration Commissioner Scott Gottlieb asked in a speech what would happen if the U.S. government re-examined the safe harbor that drug rebates have under federal antikickback laws. (Edney, 5/3)
The Hill: FDA Chief Hints At Changes To Drug Rebates Ahead Of Trump Speech
The leader of the Food and Drug Administration suggested the legal status of rebates paid by drug companies to insurers and pharmacy benefit managers could get another look to help rein in the costs of prescription drugs. In a speech on Thursday, Scott Gottlieb said if the federal anti-kickback law that protects such rebates were changed, it could help increase competition and make drugs more affordable. (Weixel, 5/3)
Stat: Kickback Law Might Be Used To Bring Down Drug Prices, FDA's Gottlieb Says
Drug companies are currently being sued by lawyers who believe that the Byzantine system of rebates that flow between pharmacy benefit managers, drug manufactures, and insurers are really kickbacks. The current interpretation of the federal law shields these rebates from legal scrutiny. (Swetlitz, 5/3)
Stat: FDA Chief Links Future Of Genetically Engineered Animals And Human Therapies
The commissioner of the Food and Drug Administration, Scott Gottlieb, waded into a debate about how much control his agency should have over genetic engineering in animals, saying that the resolution of this question will have significant implications for the future of gene-based medicine. His remarks, in a speech Thursday at the annual conference of the Food and Drug Law Institute, came less than a month after Department of Agriculture Secretary Sonny Perdue told lawmakers at a hearing that the FDA’s regulations on genetically engineered animals could stifle innovation. (Swetlitz, 5/3)
Stat: Can Trump Use The Bully Pulpit To Lower Drug Prices? Don't Bet On It
President Trump has not yet made his much-ballyhooed speech on drug prices, and a rumored executive order never came to pass. And yet in Washington there are already suggestions among some administration officials that the political climate created by the president — to say nothing of his comments about drug makers “getting away with murder” — has helped keep prices in check. ... But experts argue that the slowdown has been driven by a series of factors unconnected to the White House. There have been relatively few (expensive) blockbuster drugs released over the past year. Fewer people are using some of the blockbuster drugs of years past. Pharmacy benefit managers continue to negotiate rebates to help bring down the prices people actually pay at the pharmacy counter. And generic prices are decreasing, too. (Mershon, 5/4)
Stat: Wall Street Analyst To Pharma: 'You Do Not See The Trouble Brewing'
Before a widely anticipated speech that President Trump is slated to give next week about drug pricing, one analyst cautions both drug makers and their cheerleaders on Wall Street that their world is about to change – big time. In a pointed note, Wells Fargo analyst David Maris makes clear the ironic dilemma facing the pharmaceutical industry: The enthusiasm for “incredible innovation” is tempered by a public that is “increasingly hostile” to paying for breakthroughs and advances. Why? He cites “unconscionable” price hikes that have “hardened” many opinions. (Silverman, 5/3)
