KHN Morning Briefing

Summaries of health policy coverage from major news organizations

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Likely On Way Out, FDA Chief Defends Drug Effectiveness

Elsewhere, fewer drugs were approved this year, critics worry the 21st Century Cures Act could make patients more vulnerable and insurers change how they pay for insulin after higher prices.

The Washington Post: The Head Of The FDA Defends The Importance Of Drug Effectiveness
First things first: Food and Drug Commissioner Robert Califf says that he has not had any contact with the Trump transition team. That's the latest sign that the cardiologist, confirmed as FDA chief less than a year ago, will be heading back to Durham, N.C., where he's on leave from Duke University. Still, he has no regrets: “Everyone who knows me knows I have just had fun every day on the job,” he said in an interview. (McGinley, 12/29)

Stat: FDA Drug Approvals Plummeted This Year, But 2017 Is Looking Rosier
Among the many stats that illustrate the biopharma industry’s rough and tumble 2016, new drug approvals fell to their lowest total in nearly a decade after a booming few years. What happened? If you ask the Food and Drug Administration, drug makers got a little worse at their jobs, and the agency got better at its own. But some analysts say it’s likely just a calendar-related blip that should give way to a more profligate 2017 and beyond. (Garde, 12/30)

USA Today: Soaring Insulin Prices Prompt Insurance Shift
Many parents of diabetic children and adults suffering with type 1 or type 2 diabetes are bracing for changes in insurance coverage of their insulin next year, as prices of the vital medication continue to soar. Higher insurance deductibles and changes in the prescription brands covered by some insurers are raising concerns among some people with diabetes. (O'Donnell, 1/2)

Stat: Whistleblower's Off-Label Marketing Suit Against Celgene Can Proceed To Trial, Judge Rules
A federal judge in California has ruled that a multi-billion dollar whistleblower case against biotech giant Celgene Corp. can proceed to a jury trial. The case alleges that Celgene marketed two drugs for unapproved uses, causing the government to pay for hundreds of thousands of “off-label” prescriptions. In an opinion issued Wednesday night, Judge George H. King, of the Central District of California, wrote that former employee Beverly Brown had provided solid evidence to support her claim that Celgene promoted Thalomid and Revlimid for use in cancer patients. The FDA had approved the drugs only for other purposes, and the company was not permitted to pitch it to doctors for unapproved, or off-label, uses. (Kaplan, 12/29)

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