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FDA commissioner rattles healthcare industry with ‘warning shot’ over drug rebates. The healthcare industry is growing worried after the head of the FDA suggested that a federal law to prevent kickbacks should be used to rein in high drug prices. Wall Street analysts say FDA Commissioner Scott Gottlieb’s remarks signal that the administration could be more aggressive than it has been in taking on high drug prices and the drug rebate system. Gottlieb and Health and Human Services Secretary Alex Azar recently have been criticizing the rebate system used by insurers and drug middlemen, called pharmacy benefit managers, to negotiate for discounts to pharmaceuticals. The officials have said that consumers don’t receive enough of the discounts negotiated between payers and drugmakers. But Gottlieb surprised the healthcare industry Thursday during a speech before the Food, Drug and Law Institute in Washington. He said the federal government could re-examine if the rebates should no longer be exempt from a federal law that prohibits kickbacks. “Such a step could help restore some semblance of reality to the relationship between list and negotiated prices, and thereby boost affordability and competition,” Gottlieb said in his prepared remarks. The federal Anti-Kickback Statute prohibits any reward or kickback used to receive business from a federal healthcare program. But it does not apply to discounts for drugs reimbursed through programs such as Medicare or Medicaid. That is what Gottlieb says should be re-examined. The comments are likely to be a “warning shot” to the entire drug chain, one analyst said. “The Trump administration and the GOP have always promoted competition and market forces as the best way to bring down drug prices, instead of the more regulatory bent of Democrats,” Rick Weissenstein, an analyst with the Cowen Washington Research Group, wrote in a note Thursday. “Gottlieb is warning that if you don’t let the market work, you will be faced with more draconian solutions in the future.”

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House committee plans to move more than 50 opioid bills by May 17. The House Energy & Commerce Committee has scheduled two hearings this month to consider more than 50 bills that take on the opioid crisis. The committee plans to hold a mark up for legislation on May 9 and another one on May 17. The schedule released Friday comes as a subcommittee advanced 57 bills that address different facets of the opioid epidemic. Committee leaders want to get the bills through the House by the Memorial Day recess.

President Trump taps Dr. Mehmet Oz. Trump has appointed Oz as one of the members of his Council on Sport, Fitness, and Nutrition, the White House announced Friday. The council has been around since 1956 and promotes programs that encourage people to be more active and to make healthy eating choices. Bill Belichick of the New England Patriots was also among the 20 appointees. Oz, the host of the “Dr. Oz Show,” interviewed Trump when he was running for president. During the segment Trump provided a one-page report typed by his longtime physician, Dr. Harold Bornstein. He revealed that he was overweight, takes a statin, and had not been in the hospital since he had his appendix removed as a child.

Happy Star Wars Day! Also, don’t smoke. Today is May 4, technically Star Wars Day due to a goofy pun (May the Fourth be with you, get it?) But it is also a time for government agencies to use “Star Wars” to promote public health goals. Chief among them, the Centers for Disease Control sent out a tweet that “you can’t rely on the force to know if you have an #STD. Testing helps you to know for sure.” The Food and Drug Administration also tweeted that “it’s a lot harder to wield a lightsaber if you’re smoking. #MayThe4thBeWithYou as you leave the pack for good.” But the Department Health and Human Services may have the best tweet, making a callback to a poster from 1977, the year Star Wars premiered, featuring the famous droids C-3PO and R2-D2 calling for the parents of Earth to fully immunize their children. It looks like Star Wars has been used to inform the public about healthcare from the very beginning.

Trump vows to sign bill funding Veterans Choice Program. President Trump cited the Phoenix Veterans Health Administration scandal on Thursday as he called on Congress to pass a bill funding the Veteran’s Choice Program. “This spring marks 4yrs since the Phoenix VA crisis. We won’t forget what happened to our GREAT VETS. Choice is vital, but the program needs work & is running out of $. Congress must fix Choice Program by Memorial Day so VETS can get the care they deserve. I will sign immediately!” Trump tweeted. The VA’s choice program is one of several through which a veteran can receive outside healthcare from a provider, paid for by VA. The program’s funds were set to reach exhaustion by January 2018, and Trump signed a continuing resolution last December to fund the program through the year. This year marks the four-year anniversary of the Phoenix VA scandal which exposed misconduct and gross negligence at the VA, sparking a national outcry for reform.

FDA gives companies more time for new nutrition labels. The FDA has extended the deadline for food companies to change their nutrition labels, for about 1.5 years. The original date was going to be July 26, 2018, and the new date is Jan. 1, 2020. For smaller companies, which bring in less than $10 million in annual food sales, the deadline is being moved until Jan. 1, 2021. The nutrition labels are part of Obamacare and were delayed several times under the Obama administration. The Trump administration said it was delaying the rules because companies need more time to get the labels onto their products. They will contain more information about serving sizes, to reflect how people eat, and will contain more information about added sugars. Gottlieb said the labels would help combat chronic illnesses such as diabetes, cancer and heart disease. “This extension on the Nutrition Facts label regulation will help ensure that we provide the food industry with guidance to help them modernize their Nutrition Facts labels and that industry has sufficient time to complete and print updated Nutrition Facts labels,” he said.

HHS seeks yearlong delay of 340B rule. Health and Human Services wants to extend by a year the deadline to implement a rule that prevents drug companies from overcharging hospitals in the controversial drug discount program 340B. The rule delay is because HHS is “in the process of developing new comprehensive policies to address the rising cost of prescription drugs,” according to the rule published Friday. The rule imposes fines for drug makers that charge too much for their products under 340B. The program requires a drug maker to give a discount to hospitals and other facilities at sharply reduced prices. The hospitals eligible for the program provide a large amount of charity care to uninsured patients. But 340B has been the subject of an intense lobbying clash between the drug and hospital lobbies as the Trump administration has made cuts to the program.

House committee plans to move more than 50 opioid bills by May 17. The House Energy and Commerce Committee has scheduled two hearings this month to consider more than 50 bills that take on the opioid crisis. The committee plans to hold a mark up for legislation on May 9 and another May 17. The schedule released Friday comes as a subcommittee advanced 57 bills that address different facets of the opioid epidemic. Committee leaders want to get the bills through the House by the Memorial Day recess.

Tom Price blames ‘gotcha politics’ in comments on Obamacare’s individual mandate. Tom Price, the former Health and Human Services secretary who resigned following a scandal surrounding his rampant jet use, blamed “gotcha politics” for Obamacare supporters taking remarks that he made about the healthcare law’s fine on the uninsured out of context. “In today’s era of ‘gotcha’ politics, my recent remarks before the World Health Congress about the effects of the individual mandate repeal were taken completely out of context,” Price wrote in an opinion piece in the Hill. “Having made the common-sense observation that absent other reforms, I noted that Obamacare patients will have to bear more of their own healthcare costs as a result.” Price told a crowd in Washington Tuesday that he believed getting rid of Obamacare’s individual mandate in the Republican tax reform, absent broader reforms, would raise costs and destabilize the law’s exchanges. He described repealing only the mandate as “nibbling at the side,” adding “there are many, and I’m one of them, who believes that that actually will harm the pool in the exchange market, because you’ll likely have individuals who are younger and healthier not participating in that market, and consequently, that drives up the cost for other folks within that market.”

Insurers to stay in exchange in Virginia, Richmond adds insurer. All seven insurers that sold an Obamacare plan in Virginia plan to offer policies in 2019, reports Louise Norris at HealthInsurance.org. Richmond also gained another insurer, Virginia Premier, which expects to gain 4,000 customers. Most states have until late June to receive submissions from insurers to participate in the exchanges, but Friday is the deadline for Virginia.

Sales of Celgene’s marquee cancer drug surge as Trump’s price crackdown looms. Sales of Celgene’s marquee cancer drug are growing despite questions about how the Trump administration’s plan to address rising drug costs will affect pharmacy companies. U.S. sales of Revlimid increased nearly 21 percent to $1.4 billion for the quarter that ended on March 31, the company said Friday. The drug drove $8.2 billion in global sales in 2017, 63 percent of Celgene’s product sales for the year. Generic competitors have long accused Celgene of abusing a safety program at the FDA for riskier drugs – known as the Risk Evaluation and Mitigation Strategy, or REMS – to restrict access to the medications, which generic rivals need to create lower-cost versions. The company has faced related antitrust lawsuits from rivals such as Mylan Pharmaceuticals. Celgene itself filed a lawsuit earlier this year to block Dr. Reddy’s Laboratories from selling a generic version of Revlimid, but doesn’t expect to make it to court in the near future.

RUNDOWN

Wall Street Journal Theranos cost business and government leaders more than $600 million

New York Times DeBlasio moves to bring safe injection sites to New York City.

Bloomberg D.C. consultant found guilty of stealing Medicare secrets

STAT News PhRMA takes aim at Medicare drug program in new ad

Reuters Printing body parts in hospital shows 3D printing’s reach

Kaiser Health News ‘Pharma bro’ Martin Shkreli is in prison, but Daraprim’s price is still too high

McClatchy Congress is a decade behind in overseeing DNA testing companies

Concord (N.H.) Monitor Sununu touts Medicaid expansion, but says he can’t support voting bill in current form