Escalating Global Recall Of Zantac Doesn’t Have Roots In Government Oversight But Rather A Tiny Online Pharmacy
The startup with only 14 employees raised flags with U.S. regulators over the safety of Zantac leading to an ever-growing recall of the product. “I had a fairly dim view of drug quality in the United States going into this, but we’ve discovered tons of problems I never even thought of — and they’re all over the place,” said Adam Clark-Joseph, one of Valisure’s founders. In other pharmaceutical news: the patent battle over the HIV prevention drug; 340B payment cuts; and Congress's struggle to contain high drug prices.
The Washington Post:
A Tiny Pharmacy Is Identifying Big Problems With Common Drugs, Including Zantac
The escalating global recall of Zantac, the heartburn pill that once ranked as the world’s best-selling drug, has its roots not in government oversight or a high-profile lawsuit, but in a tiny online pharmacy here whose founders feared that U.S. drugs might not be as safe as people think. The pharmacy, Valisure, is a start-up with only 14 full-time employees. But since its scientists alerted American regulators that Zantac and its generic form, ranitidine, contained a chemical thought to cause cancer, more than 40 countries from Australia to Vietnam have either stopped sales, launched investigations or otherwise stepped in to protect consumers from possible health risks. (Johnson, 11/8)
Miami Herald:
How Zantac Tested For Carcinogen, What Zantac Got Recalled
More prescription-strength and hospital-used ranitidine, sold over the counter under the brand name Zantac, has been recalled for having too much of carcinogen NDMA. Though the run of recalls on the heartburn drug continues, FDA testing should calm some stomachs. (Neal, 11/10)
The New York Times:
Who Owns H.I.V.-Prevention Drugs? The Taxpayers, U.S. Says
After years of prodding by patient advocates, federal officials on Wednesday sued the drug maker Gilead Sciences, charging that it had infringed government patents on the idea of preventing H.I.V. with a daily pill. The suit, by the Department of Health and Human Services, came as a pleasant shock to many critics of the company, including Democratic members of Congress who had pressed the administration to act. (McNeil and Mandavilli, 11/8)
Modern Healthcare:
HHS Defends Its Authority To Cut 340B Payments
HHS urged a federal appeals court on Friday to uphold its reimbursement cuts to providers under the 340B drug program, saying Congress gave it the authority to make the changes. Although a lower court ruled in May that the payment changes were unlawful, HHS said it can change 340B drug reimbursements just like any other payments under the Outpatient Prospective Payment System. (Brady, 11/8)
Modern Healthcare:
Drug Pricing And Surprise Billing Issues Top Health Lobbying Priorities
Healthcare industry groups spent considerable time and money this year lobbying members of Congress on two hot-button issues: surprise billing and drug pricing. It's likely that the debate will continue into the election year and the next Congress. According to data from the Senate Office of Public Records, the list of the 25 biggest spenders in health lobbying as of Sept. 30 is largely composed of pharmaceutical companies and trade associations, including top spender Pharmaceutical Research and Manufacturers of America with $22.5 million in the first three quarters of 2019. (caruso and Cohrs, 11/8)
CQ:
White House Policy Chief Pushes Senate Finance Drug Price Bill
The White House top domestic policy aide on Friday called the Senate Finance Committee’s bipartisan drug pricing bill the most likely path this year to lowering prescription drug prices. Joe Grogan, the Domestic Policy Council director, told reporters that the bill would be “the surest route to a bipartisan solution that would be a real win for Democrats, Republicans, the president and, more importantly, the American people." (McIntire, 11/8)
Kaiser Health News:
Voters Say Congress Needs To Curb Drug Prices, But Are Lawmakers Listening?
House Democrats are poised to pass sweeping legislation to lower drug prices using strategies President Donald Trump has endorsed. A Trump aide urged the Republican-controlled Senate to vote on a different package curbing drug prices that was drafted by a senior Republican. But at least right now, neither measure appears likely to attract enough bipartisan support to become law. (Huetteman, 11/11)
