J&J’s TURN IN THE BOOSTER SEAT — The FDA’s outside advisory committee will scrutinize Johnson & Johnson’s case for a Covid-19 booster today, in a third and final session on boosters that could also prove to be the most unpredictable. At issue is not just whether J&J recipients should get an additional shot, but when: The vaccine maker is asking the FDA to vary the timing based on an individual’s personal circumstances, POLITICO’s Lauren Gardner reports. High-risk people would get a booster just two months after their initial shot, with the rest receiving it six months out. Both groups would get a benefit at no additional safety risk, the company wrote in its proposal – though the six-month interval appears to provide the most protection. But don’t call it a two-dose vaccine. Despite studying the impact of giving a second shot just two months afterward, J&J has maintained it’s a one-dose vaccine – unlike competitors Moderna and Pfizer. The question is whether the advisers will buy it. FDA scientists in their own set of documents suggested earlier this week that there may not be sufficient evidence to justify people waiting six months for their J&J booster. One more wrinkle: The panel could also discuss new NIH research showing that giving J&J recipients a dose of Moderna or Pfizer’s vaccine is actually more effective than a second shot of J&J – data that could further complicate its final recommendations. Meanwhile, Moderna’s booster skated through a Thursday advisory committee meeting , with the panel endorsing the shot for the elderly and younger people whose jobs or underlying conditions put them at higher risk. That unanimous vote came even as some advisers lamented the limited data they had to rely upon to make the decision. DEMS’ DRUG PRICE DREAMS ARE FADING — Democrats still have a ways to go toward securing a deal on drug pricing – and even if they succeed, it’ll be far narrower than the sweeping overhaul party leaders once sought, POLITICO’s Alice Miranda Ollstein reports. That’s the takeaway from remarks made Thursday by Speaker Nancy Pelosi and moderate Rep. Scott Peters, who remains among the key holdouts on Democrats’ plan to slash drug costs. “We’re still making that fight,” Pelosi told California’s KQED about the effort to allow the government to directly negotiate the price of medicines. “I’m not even sure we’ll get it in this bill. Pelosi added that the multitrillion-dollar social spending package will likely have “something” on the issue – but “it won’t be the complete package that many of us have been fighting for a long time.” Peters, meanwhile, confirmed that negotiations over the legislation remain at an impasse. “We’re not ready for this,” he said during a panel hosted by the Alliance for Aging Research, citing the difficulty of constructing the package without knowing what top-line number the Senate will ultimately support. The California Democrat, who is pushing his own, more industry-friendly drug pricing alternative, also detailed a pair of demands necessary to win his support: Get rid of a proposed excise tax on companies that don’t comply with the government’s price negotiations, and leave new drugs out of the negotiation process. Rather, Peters argued that any negotiation should only happen once patents expire over concerns that doing it earlier could discourage investment in novel therapies. ROB CALIFF EMERGES AS TOP FDA CANDIDATE — The White House is weighing bringing back former FDA Commissioner Robert Califf as its pick to run the agency, according to four people with knowledge of the situation. The decision isn’t final, and the situation could still change. But nine months into the drawn-out search process, Califf is now seen as the leading candidate for the permanent job. If nominated, it would represent a homecoming for the 70-year-old cardiologist. Califf spent a year as FDA commissioner during the Obama era, and had previously been deputy commissioner of the agency’s Office of Medical Products and Tobacco. He’d return to FDA during a high-stakes period. The agency is at the center of the pandemic response, with responsibilities ranging from vetting vaccines to developing therapeutics and tests. It’s also navigating new e-cigarette policies and broadening oversight of over-the-counter products. But first, Califf needs to pass muster with Biden and then a narrowly divided Senate. The White House has struggled to find a consensus candidate after several Democrats signaled they wouldn’t support acting FDA chief Janet Woodcock. And while Califf won broad bipartisan support during his initial confirmation in 2016, he drew opposition from Democratic senators who now wield outsize influence: Joe Manchin, Ed Markey and Richard Blumenthal. Califf could also face fresh pushback over his ties to Google, where he helped lead health policy at its parent company Alphabet. Already, groups including Public Citizen and the Revolving Door Project have raised objections to his potential nomination. | 
