With help from Allie Bice
PROGRAMMING NOTE: Prescription Pulse will not publish on Friday July 5, but will be back on schedule Tuesday, July 9.
Story Continued Below
— Oklahoma portrays J&J as ‘kingpin’ of opioid crisis as lawsuit continues.
— Lower prices could happen with policies to lower R&D costs, according to a Health Affairs blog.
— Has FDA enforcement slipped in the Trump administration? Science investigates, FDA pushes back.
Happy Wednesday and welcome back to Prescription PULSE. Congrats to USWNT on their semifinal win, and Happy 4th of July! Who’s watching the final Sunday? As always, send news and tips to Sarah Owermohle (email@example.com or @owermohle).
OKLAHOMA PORTRAYS J&J AS OPIOID CRISIS ‘KINGPIN’ IN COURT BATTLE — Johnson & Johnson’s role providing raw materials for opioids was key in fueling the addiction epidemic in Oklahoma, state officials argued during the first half of a landmark trial that could have ramifications for hundreds of similar lawsuits across the country.
The first five weeks of the lawsuit featured testimony from addiction experts and state health officials pointing the finger squarely at Johnson & Johnson subsidiary Janssen Pharmaceuticals, Pro’s Paul Demko reports. Their argument: Janssen provided the ingredients that were essential to hooking people on popular painkillers like Purdue’s Oxycontin, even if the actual pills were sold by other drugmakers.
J&J has fought back, saying state officials had some responsibility and arguing that Oklahoma is trying to scapegoat the company for a sprawling public health crisis.
The trial could be a bellwether for hundreds of other lawsuits heading to trial, many of which are bundled in front of a judge in Ohio. The other two original defendants in Oklahoma, Purdue and Teva Pharmaceuticals, have already settled for a combined $355 million — a fraction of what state officials say they need to combat the epidemic. Pros can read Paul’s full breakdown of the case.
SHIFTING INCENTIVES TO DRIVE LOWER PRICES — U.S. regulators should rethink how they use incentives like tax breaks, market exclusivity and other designations to drive pharmaceutical innovation while controlling costs, write biopharma policy expert Rena Conti and R&D consultant Frank David in a new Health Affairs blog post. The problem is that evidence for other options is sparse. Conti and David, who runs R&D consultancy Pharmagellan, recommend asking pharmaceutical companies what incentives drive their R&D decisions, and implementing experiments like market entry rewards for new antibiotics. In the meantime, they write, the government should crack down on “rent-seeking behavior” that blocks new competition.
Reducing high prices on its own may simply curb R&D spending, they conclude — a common refrain in the pharmaceutical industry. “However, it may be possible to mitigate the negative effects of reducing high prices — one part of revenue — by simultaneously implementing other policies to promote drug use and reduce R&D costs,” Conti and David write.
ICYMI: ALEX AZAR, JOE GROGAN PEN EDITORIAL ON LOWER PRICES — The HHS secretary and the White House domestic policy chief touted the administration’s efforts to lower drug prices in a joint op-ed in the New York Post on Tuesday. Azar and Grogan pointed to the president’s recent executive order to boost transparency (largely focused on providers and insurers) and shouted out to the pending rebate rule, which they said could deliver savings to consumers as soon as Jan. 1, 2020.
…The Azar-Grogan collaboration comes weeks after POLITICO reported on tensions between HHS and the White House, with Azar and Grogan sparring over health strategy. Also this week, drug companies announced a new round of price hikes though the rate of increase may be slowing, as we reported.
HAS FDA ENFORCEMENT SLIPPED UNDER TRUMP? FDA has issued far fewer warning letters during the Trump administration than in the last years under Obama, Science magazine reports in a new investigation. Letters have dropped by one-third overall, with even steeper declines among local offices and device regulators. Injunctions — generally the next, harsher step after warnings — also fell, Science reported.
But it’s not across the board: Letters from the Center for Drug Evaluation and Research — which assesses new drugs — actually rose from 116 in the last Obama years to 188 under Trump, a 62 percent increase. Concern over opioid sales and safety issues from generic and over-the-counter drugs made in China and India largely drove that increase, wrote Science’s Charles Piller.
But he also reported that warning letters from the Center for Tobacco Products dropped 33 percent, even as former Commissioner Scott Gottlieb declared a teen vaping epidemic and a crackdown on e-cigarette sales.
FDA pushes back. A spokesperson said the tobacco figures were “inaccurate and misleading” because they did not include the more than 1,300 letters issued to retailers last summer as FDA ratcheted up its focus on underage vaping.
On devices, the agency pointed to a steady climb in facility inspections, which can lead manufacturers to fix violations before a letter is issued. Inspections have increased since 2008 — so well before Trump took office — reaching nearly 3,000 a year in 2017.
“Our use of any one enforcement tool may fluctuate year to year based on a number of factors,” said an FDA official.
WARREN CALLS ON GOTTLIEB TO RESIGN FROM PFIZER BOARD — Massachusetts Senator Elizabeth Warren called on former FDA Commissioner Scott Gottlieb to resign his new post on the U.S. pharmaceutical giant’s board in a letter Monday, saying it would send a “strong and necessary message” on ethics.
“This will certainly be a lucrative move for you — according to Pfizer, board members in 2018 were paid $142,500 in cash retainers, plus received $192,500 worth of Pfizer stock,” Warren wrote. But the move “smacks of corruption” and would erode public trust in high-level Trump administration officials, the 2020 presidential hopeful said.
Gottlieb not backing down: “I worked with some large drugmakers before I came into the agency,” he said on CNBC. “I made no bones about the fact that I had expertise in life sciences and I made my living trying to promote innovation in this sector prior to coming to the agency.”
…Warren in her letter pointed out that he’d be the second high-level Trump official in as many months to join the board of a corporation in the public spotlight, after former DHS Secretary and Chief of Staff John Kelley was elected to Caliburn, whose subsidiary runs the Homestead child detention center in Florida.
LOUISIANA HIV CASES HIT DECADE LOW — Fewer people have been diagnosed with HIV in the past year than in any of the previous 10, the state’s department of health announced Tuesday. There were 938 new cases last year, the first time since 2005 that new infections dipped below 1,000.
Alexander Billioux, assistant secretary of health, attributed the trend to successful viral suppression for those who are living with HIV and increases in routine screening throughout the state.
“This provides even more support for the importance of knowing your status and taking control of your infection to suppress the virus,” Billioux said.
SMITHSONIAN REJECTS REQUEST TO CHANGE SACKLER NAME — The Smithsonian Institution turned down a request from Sen. Jeff Merkley (D-Ore.) to change the Sackler Museum’s name because of the unsavory reputation of the family over its control of Purdue Pharma. Merkley wrote in a June 19 letter that the Sackler name “has no place in taxpayer funded public institutions.” In response, Smithsonian Secretary Lonnie G. Bunch III wrote that the institution will be keeping the name, The Washington Post reports. “The legal agreement signed between the Smithsonian and Arthur M. Sackler was in keeping with the Smithsonian’s recognition practices at the time and obligated the Smithsonian to designate the facility as the Arthur M. Sackler Gallery in perpetuity,” Bunch wrote.
FDA STEPS UP WARNINGS ON KRATOM — The increasing popularity of kratom, a highly addictive drug that some sellers falsely claim curbs opioid abuse, has prompted FDA action, the Detroit Free Press reports. The FDA issued a warning letter to a distributor in North Carolina for falsely advertising its kratom products as helping with chronic pain, migraines and opiate addiction. But Detroit Free Press reports kratom popularity is on the rise — not leas because “it’s readily available in stores and online and “it doesn’t always show up on drug screens.”
FDA announced it would eliminate the risk evaluation and mitigation strategy, or REMS, program for Truvada and its four generics.
The Epilepsy Foundation released updated principles and positions on access to prescription medications in response to various efforts to address high drug prices, rising out-of-pocket costs and insurance hurdles.
CMS finalized its national coverage policy expanding coverage for ambulatory blood pressure monitoring, a diagnostic to track blood pressure.
FDA issued warning letters to three repackers of active pharmaceutical ingredients for significant violations of manufacturing requirements.