FDA Chief Blasts ‘Rigged System’ Of Complex, Secret Deals That Keeps Generics Off Market, Hurts Patients
FDA Commissioner Scott Gottlieb's sharp words for the pharmaceutical industry are seen as a strong signal of his interest in curbing high drug costs.
Stat:
Gottlieb Condemns 'Rigged Payment Scheme' For Biosimilar Drugs
Food and Drug Administration Commissioner Scott Gottlieb said that it’s not his agency’s job to regulate drug prices — but on Wednesday morning, he used his bully pulpit to condemn a “rigged payment scheme” that he said he fears is keeping some generic drugs out of the market. Speaking to a group of hundreds at a conference run by America’s Health Insurance Plans, Gottlieb spoke about the challenges facing biosimilar manufacturers, which make generic biologic drugs. He called on the audience primarily of insurance professionals to do something, offering a few concrete suggestions. (Swetlitz, 3/7)
The Hill:
FDA Commissioner Says 'Rigged' System Raises Drug Costs For Patients, Discourages Competition
Complex and secret deals between drug distributors, pharmacies, insurers and other key players have kept less expensive drugs off the market, he argued during a speech at a conference Wednesday for major health insurance companies. “The rigged payment scheme might quite literally scare competition out of the market altogether,” Gottlieb said. (Hellmann, 3/7)
Bloomberg:
‘Rigged’ System Blocks Use Of Lower-Cost Drugs, FDA Chief Says
The speech is some of the Trump administration’s broadest criticism yet of the health-care industry amid an ongoing debate about the cost of drugs and company-led efforts to and deal with rising health-care costs. Warren Buffett, whose Berkshire Hathaway Inc. has joined with Amazon.com Inc. and JPMorgan Chase & Co. to look at how the companies might address the issue, has called health costs a “tapeworm” eating at the inside of companies.
(Edney, 3/7)
The Wall Street Journal:
FDA Puts Drug Supply Chain On Notice
Granted, the FDA isn’t capable of directly regulating drug prices. Investors shouldn’t take comfort in that fact, however. The Department of Health and Human Services, which includes the FDA, can take actions without waiting for legislation and has stated that high drug prices are a priority for the administration. The Council of Economic Advisers sharply criticized the market concentration of pharmacy-benefit managers in a report earlier this year as a factor in keeping drug prices high. Investors shouldn’t forget that midterm elections are only eight months away and that drug prices are a big issue for voters. Individual states also can create headaches for the industry. (Grant, 3/7)
Related KHN video: Middlemen Who Save $$ On Medicines — But Maybe Not For You
Also, from the FDA —
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FDA Objects To Company Promoting Its Hemophilia Drug With Soccer Player
Never mind the hemophilia, a soccer player can still confidently bump into others while hustling downfield thanks to the Idelvion treatment, at least according to CSL Behring promotional materials, anyway. The drug maker used such an image — specifically, a man who is about to head or kick a soccer ball while jumping high in the air — to promote its hemophilia B medication on its product website and in patient brochures, exhibit panels, and sales aids. (Silverman, 3/7)
The Associated Press:
FDA Did Not Issue New Statement On Vaccines And Autism
Some health websites have misrepresented the fine print on an old vaccine label to falsely claim that the "FDA announced that vaccines are causing autism." Vaccines do not cause autism and the U.S. Food and Drug Administration did not make any new statement this week about the long-debunked claim. Autism was listed as one of many "adverse events" on the 2005 label of Sanofi Pasteur's Tripedia childhood vaccine for diphtheria, tetanus and pertussis. (3/7)