FDA’s Process Dinged For Being ‘Burdensome And Slow,’ But It’s Faster Than Its European Counterpart
Dr. Scott Gottlieb, President Donald Trump's pick to head the Food and Drug Administration, has been focused on what he'll do to speed up the drug approval process to make it more like Europe. But the FDA is actually faster already. Meanwhile, a Medicare advisory panel backs a plan that could save $5 billion over five years in drug costs. And taxpayers fund pharmaceutical research but then have to pay exorbitant prices on those drugs -- but if the U.S. government doesn't do it, no one will.
Los Angeles Times:
Speed Up Drug Approvals At FDA? It's Already Faster Than Europe's Drug Agency
Dr. Scott Gottlieb, President’s Trump’s nominee to head the Food & Drug Administration, has said the FDA displays an “unreasonable hunger for statistical certainty” and a “profound lack of confidence in the ability of doctors to make careful judgments. ”In a bid to speed reviews and “change the FDA review culture itself,” Gottlieb proposed in a 2012 article that the FDA should follow the lead of its European Union counterpart, and let “a body of politically appointed (and therefore politically accountable) officials … ultimately [decide] on whether a new drug should be approved.” (Healy, 4/6)
CQ Roll Call:
Panel Recommends Overhaul Of Medicare Pay For Certain Drugs
A Medicare advisory panel on Thursday backed recommendations that may shave as much as $5 billion over five years from the giant health program’s expenses for drugs administered in doctors’ offices, such as costly medicines for cancer and arthritis. The panel’s work is likely to attract opposition from drugmakers, who are already objecting, and physicians. The Medicare Payment Advisory Commission, which advises Congress, offered unanimous support for the package in a vote taken by a show of hands, even with some of the panelists expressing reservations about aspects of the wide-ranging plan. Panelist Craig Samitt, who couldn’t attend the morning session, may cast a vote later, MedPAC staff said. (Young, 4/6)
If Not The US, Who Will Pay For Drug Development?
American taxpayers pour money into basic biomedical research, supporting the development of drugs that pharmaceutical companies sell back to those same taxpayers at exorbitant price tags — and in other countries for much less. So the argument goes, striking some as unfair to Americans. But if the United States doesn’t underwrite the research, nobody else will, said Bruce Stillman, president of Cold Spring Harbor Laboratory, during a visit to STAT’s offices Thursday. (Swetlitz, 4/6)
In other pharmaceutical news —
Do Drug Makers' Access-To-Medicines Program Actually Work?
A decade ago, United Nations officials implored the pharmaceutical industry to expand access to medicines to low- and middle-income countries, and many companies have heeded the call. But a new analysis finds that evidence to evaluate and report the effectiveness of these initiatives is lacking. First, the good news: The number of initiatives operated by 21 global drug makers increased to 102 in 2015 from just 17 in 2000. And of the 120 access to medicines programs that were identified, 48 percent donated pharmaceuticals and 44 percent relied on a strategy for reducing prices. Only 22 percent involved licensing to other companies. (Silverman, 4/6)
Latest Attempt To Curb Medicare Part B Drug Costs Panned By Doctors And Drugmakers
Drugmakers and providers say the newest proposal to change the way drugs are paid for under Medicare Part B is likely dead in the water. The Medicare Payment Advisory Commission Thursday voted 15-0 to recommend that Congress enact new drug reimbursement laws through several proposals that would decrease Medicare spending by as much as $750 million in the first year of implementation and $5 billion over five years. (Dickson, 4/6)
Blame Game Over High Drug Prices Escalates With New Ad
Broadening its efforts to defuse outrage over skyrocketing prices, Pharmaceutical Research and Manufacturers of America, the industry’s lobbying association, started an advertising campaign urging insurers to share with customers more of the benefits of rebates they’ve negotiated. In response, the main health-insurance lobby pushed the blame back on drugmakers: “Enough with the distractions.” Meanwhile, the head of one of the largest pharmacy benefit managers, who are often criticized by drugmakers for their lack of transparency, said his industry helps save money and manufacturers should stop faulting the middlemen. (Hopkins and Tracer, 4/6)
Ailing Novo Seeks Cure With Diabetes Drug Targeting Fat Too
Novo Nordisk A/S has a potent new medicine that Chief Executive Officer Lars Fruergaard Jorgensen is counting on to nurse the drugmaker back to health. The experimental treatment, called semaglutide, should go on sale next year as an injection for diabetes. But that’s only the first step of Novo’s development plan: Its scientists are working on a patient-friendly tablet version of the drug that could reach pharmacy shelves in 2020. They’re also testing the product for a form of liver disease, a market some analysts say may eventually yield $35 billion a year in sales, as well as obesity. (Paton, 4/7)