New surge, same challenges

Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.

Jul 20, 2022 View in browser   By Krista Mahr and Sarah Owermohle Presented by Editor's Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our subscribers each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day's biggest stories.  Act on the news with POLITICO Pro . WELCOME TO WEDNESDAY PULSE — It appears tickets sold out within hours to the DC Health two-day Rodent Control Academy for D.C. residents. That seems … concerning.   A message from PhRMA: Today, there are 90 medicines in development for Alzheimer's disease, 119 medicines for breast cancer, 26 medicines for childhood diabetes… But government price setting could mean fewer medicines in the coming years. Which diseases could go untreated if Congress passes government price setting? There is a better way to lower costs without risking new medicines.   Driving the Day State leaders are struggling for new strategies to fight a pandemic already exhausting constituents. | Morry Gash - Pool/Getty Images NEW COVID WAVE, SAME OLD SOLUTIONS — State officials have run out of ideas when it comes to messaging around the latest Covid-19 wave, a concession to the reality that their messages rarely resonate and that most people are ready to move on, POLITICO's Megan Messerly, Adam Cancryn and Krista report . Officials in 10 states told POLITICO no new plans or bold initiatives are on the horizon, even as much of the South remains unvaccinated and vaccination uptake among children nationwide is well below what state and federal officials would like. Instead, their strategies for managing 130,000 new daily Covid cases in the U.S. are largely the same as they were for managing 30,000 new daily cases four months ago. Officials in both red and blue states worry that if they sound the alarm on this surge too early, the public won't listen later if hospital capacity becomes strained or the number of daily deaths rapidly increases. Instead of hitting the panic button, governors are hewing closely to their long-term Covid response plans announced this spring and, in some cases, continuing to step down their pandemic response. The White House, for its part, is concerned by the fast pace of the BA.5 subvariant's spread but has yet to take action after discussions on whether to permit Americans under 50 to get a second booster shot to provide extra protection over the next few months. Instead, the Biden administration has opted for a more low-key approach, targeting individual communities most at risk for the virus. Covid coordinator Ashish Jha has made several media appearances emphasizing the need for older people to get their boosters and for everyone to consider masking in high-transmission areas. FDA PREPS FOOD, TOBACCO RECKONING — Food and Drug Administration Commissioner Robert Califf said Tuesday that he's ordered an external review of the agency's offices on food safety and tobacco regulation amid growing scrutiny over the agency's response to the baby formula shortage. The FDA has hired the Reagan-Udall Foundation to conduct the review. The foundation, an independent group tasked by Congress with advising the FDA and helping the agency improve its regulatory and oversight processes, will assess the resources, procedures and organization of the two offices, as well as parts of the Office of Regulatory Affairs, the division that conducts inspections. How this happened: Besides congressional pressure, Califf and top FDA officials have heard from outside groups in private meetings in recent months, especially in the past few weeks, urging them to appoint a deputy commissioner of foods and enact larger reforms to the foods programs. PHARMA TO RESERVE VACCINES, WITH STRINGS — The pharmaceutical industry is willing to reserve an allocation of vaccines, treatments and tests for poorer countries when the next pandemic hits, with quite a few caveats, POLITICO Europe's Ashleigh Furlong reports . The proposal to G-7 and G-20 leaders , launched Tuesday, would let companies set aside production capacity for people in low-income countries, a bid to fix gaps exposed during the Covid-19 pandemic. But, in turn, it requires countries to respect companies' intellectual property rights, a coup for drugmakers seeking to stall IP waiver discussions. Notably, Gavi, the Vaccine Alliance and Indonesia, the current head of the G-20, have already indicated that they back the proposal, dubbed the Berlin Declaration. OVERDOSE DEATHS SPIKE IN PEOPLE OF COLOR — Most everyone knows by now the pandemic was bad news for U.S. overdose deaths, which hit record highs in 2020 and then again in 2021. But a new CDC report released on Tuesday shows how disproportionately the impact was on communities of color, Krista reports . Overdose death rates rose 44 percent in 2020 for Black people and 39 percent for American Indian and Alaska Native people, compared with 22 percent for white people. Black youth ages 15 to 24 saw an 86 percent increase in overdose deaths, the largest spike of any age or race group, while Black men 65 and older were nearly seven times as likely than white men to die from an overdose. At the same time, Black people were less than half as likely as white people to have received substance use treatment, the report found. And in areas where more opioid treatment programs are available, opioid overdose rates were even higher than in areas with lower treatment availability, particularly among Black, American Indian and Alaska Native persons.   A message from PhRMA:   HOW PLANS CAN IMPROVE RACE AND ETHNICITY DATA — A new report published today by the Urban Institute has a series of recommendations on how health plans and other organizations can improve the collection of race and ethnicity data to work to advance health equity. Some highlights: Build consumer trust and engagement to overcome community distrust that may make people hesitant to share personal data because of fear of discrimination, for example.  Reduce legal concerns and uncertainty among employers who worry they're not allowed to collect race and ethnicity data, despite no state or federal laws that prohibit them from doing so.  Ensure that organizations have adequate capacity and resources to use the obtained data effectively. In Congress LGBTQ+ ADVOCATES CALL ON CONGRESS TO ACT ON MONKEYPOX — Leaders in public health and LGBTQ+ health advocates are calling on Congressional leadership to include $100 million in the fiscal 2023 appropriations bill "to ensure our country has sufficient resources to mount a robust response to the escalating monkeypox outbreak." In a letter sent Tuesday to Sens. Patrick Leahy (D-Vt.) and Richard Shelby (R-Ala.) and Reps. Rosa DeLauro (D-Conn.) and Kay Granger (R-Texas), the coalition noted that the government had launched an early response to the outbreak but the nation's underfunded public health care system has struggled to respond. "The U.S. response to monkeypox is a prime example of how an underfunded public health system buckles under pressure during a rapid outbreak," said David Harvey, executive director of the National Coalition of STD Directors (NCSD). "We've had countless opportunities to prepare for this moment — mostly recently with COVID — and have instead chosen to dither and delay. That is now costing us." At the Agencies FDA CAN PAY EMPLOYEES 'TILL NOVEMBER — The agency has enough carryover funds to continue paying employees whose salaries are paid by user fees for another month after the programs expire on Sept. 30 , our David Lim and Lauren Gardner report. "Enough to go through the first of November is what they tell me," Sen. Richard Burr (D-N.C.) told reporters Tuesday amid a deadlock over renewing fees that fund drug, biosimilar and medical device regulation. The carryover funds might allow the FDA to delay issuing pink slips for several weeks rather than at the beginning of August, as some feared. The development comes as congressional health policy writers continue to work on a deal to reauthorize medical product user fees for the next five fiscal years. But there's a standstill. Burr and Senate HELP Chair Patty Murray (D-Wash.) both told POLITICO Tuesday that they haven't met in person to discuss the issue in the days since Burr introduced a stripped-down reauthorization bill that doesn't include major riders or amendments on Thursday. CDC PANEL RECOMMENDS NOVAVAX SHOT — An external advisory committee to the Centers for Disease Control and Prevention on Tuesday voted 12-0 to recommend the Novavax vaccine for adults who haven't received Covid-19 vaccinations. What's next: There's hope that a more traditional vaccine technology would encourage hesitant adults to finally get their shot. But the polling — including by CDC — hasn't suggested it will sway the most hesitant much, Katherine writes. Also, variants loom large. Although advisers were unanimous in their support of the Novavax vaccine as an additional option, many wondered how it would fit into the rollout of Omicron-specific vaccines and boosters in the future. IN THE STATES DOCTOR MULLS LAWSUIT IN ABORTION BATTLE — The OB/GYN who provided an abortion for a 10-year-old girl from Ohio took a step toward suing Indiana Attorney General Todd Rokita for defamation on Tuesday — saying his public threat to criminally prosecute her caused "reputational harm and emotional distress." The child had to travel from Ohio to Indiana because she was just a few days past her home state's six-week limit for abortions, which includes no exemptions for rape or incest. Caitlin Bernard claims Rokita made statements in media appearances and press releases over the past week that he "recklessly and/or negligently failed to ascertain" were true, including suggesting without evidence that Bernard violated the patient's HIPAA privacy rights and failed to file the proper paperwork required after treating a minor. What We're Reading In light of the case of the 10-year-old girl from Ohio, The New York Times' Stephanie Nolen reports on the toll pregnancy and delivery takes on children's bodies. STAT's Jonathan Wosen delves into the biotech firm that's betting changes in diet can reshape cancer care. Why you should still mask up on planes, according to Saahil Desai in The Atlantic .   A message from PhRMA: Today, there are 90 medicines in development for Alzheimer's disease, 119 medicines for breast cancer, 26 medicines for childhood diabetes… But government price setting could mean fewer medicines in the coming years. Which diseases could go untreated if Congress passes government price setting? There is a better way to lower costs without risking new medicines.     Follow us on Twitter Tucker Doherty @tucker_doherty Dan Goldberg @dancgoldberg Erin Banco @ErinBanco Katherine Ellen Foley @katherineefoley Lauren Gardner @Gardner_LM Ben Leonard @_BenLeonard_ Rachael Levy @rachael_levy David Lim @davidalim Krista Mahr @kristamahr Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Sarah Owermohle @owermohle Carmen Paun @carmenpaun Megan R. Wilson @misswilson   Follow us

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