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Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim and Sarah Owermohle | Presented by CVS Health | With help from Emily Martin, Susannah Luthi and Carmen Paun. | | | — Covid-19 vaccines appear to be nearly as effective in the real world as in trials, a pre-print study suggests. — Biden admin plots an expansion of Covid-19 testing. — FDA, USDA leaders say there is no evidence Covid-19 has been transmitted by food or food packaging. It’s Friday, welcome back to Prescription Pulse. As always, send tips to Sarah Owermohle (sowermohle@politico.com or @owermohle) and David Lim (dlim@politico.com or @davidalim). | | A message from CVS Health: Throughout the COVID-19 pandemic, CVS Health has been there. We’re nearly 300,000 employees ensuring millions of Americans can access health care services. We’ve opened thousands of COVID-19 test sites and administered millions of tests. Now, we’re providing the vaccine in designated states and long-term care facilities. We’ve been on the frontlines, making health care easier to access and afford. Learn more. | | | | | | REAL-WORLD EVIDENCE BACKS UP VAX TRIALS — The Pfizer/BioNTech and Moderna vaccines are nearly as effective in practice as in clinical trials according to a pre-print by Mayo Clinic researchers released on MedRxiv. The shots were 88.7 percent effective after two doses in more than 31,000 people, researchers said, comparing with the 91.4 percent efficacy for Moderna and 95 percent efficacy for Pfizer and BioNTech in trials. The study has not yet been peer-reviewed. Why it matters: Clinical trials by design need to eliminate outside factors to assess efficacy, so in a way are “perfect” conditions for a vaccine or medicine. In the real world, with a range of people, conditions and outside factors that are not always represented in trials, that can get messy. The Mayo Clinic also said that vaccinated patients had significantly lower hospitalization rates than unvaccinated peers. NEXT STEP: PREGNANCY AND COVID STUDIES — Pfizer and BioNTech said Thursday that they enrolled the first participants in a 4,000-person trial studying their Covid-19 vaccine in pregnant women. Women in the phase 2/3 trial, stretching from North to South America, Africa and Europe, will be unblinded shortly after giving birth so those who received the placebo shots can get vaccinated. Scientists have called for more details about coronavirus vaccination during pregnancy, especially during meetings of the CDC’s expert panel on vaccines. Remdesivir study also in the works: The National Institutes of Health funded a new study evaluating Gilead’s coronavirus treatment in pregnant women sick with the virus. Like with vaccines, treatment data in pregnant women is very limited. The NIH study in the U.S. and Puerto Rico will track how the drug is absorbed and moves through the body. Samples will be taken from plasma, the umbilical cord and breast milk of women receiving the medicine around the time of birth. BIDEN ADMIN TO INVEST $1.6 BILLION INTO TESTING, SEQUENCING — The White House announced Wednesday a multipronged effort to bolster the nation’s ability to test for Covid-19 in schools and homeless shelters, increase domestic manufacturing of testing supplies and boost genomic sequencing efforts needed to understand the spread of virus variants. CDC will use approximately $200 million to increase its capacity to sequence the genomes of virus samples from 7,000 per week to 25,000. The administration is allotting $815 million to support domestic manufacturing of supplies for Covid-19 testing such as pipette tips, molded plastics and a key ingredient for rapid antigen tests. Health officials said $650 million will be used to increase access to testing in non-medical settings, such as K-8 schools and underserved congregate facilities, including homeless shelters. HHS aims to open three to four coordinating centers that will work with up to 36 labs to boost U.S. testing capacity by up to an additional 25 million per month as part of the effort to reopen schools, according to a Thursday HHS memo obtained by POLITICO. Test manufacturers, commercial or academic labs, non-profit groups and laboratory service companies are eligible to qualify as coordinating centers. “This is an important step forward that will increase the nation’s testing capacity to enable K-8 schools to open, and stay open, for in-person learning while attempting to minimize disruptions to the existing COVID-19 testing supply chain,” the HHS memo states. | | | | Designed specifically for regulatory affairs professionals - AgencyIQ FDA Forecast 2021: In its inaugural year, AgencyIQ's FDA Forecast predicts the FDA regulatory changes that will take place in 2021 and what they will mean for the life sciences industry. Read more about the report and download the summary here. | | | | | | | | USDA, FDA LEADERS SAY COVID NOT TRANSMITTED BY FOOD — Top officials at the U.S. Department of Agriculture and FDA said Thursday that “there is no credible evidence” that the virus that causes Covid-19 is likely transmitted via food or food packaging. "Considering the more than 100 million cases of COVID-19, we have not seen epidemiological evidence of food or food packaging as the source of SARS-CoV-2 transmission to humans," Acting USDA Secretary Kevin Shea and Acting FDA Commissioner Janet Woodcock said. The statement comes after an international team of experts looking into the virus origin on a trip to China said that it is possible for the virus to have spread through frozen wild animals which were sold in bulk at the Huanan seafood market in Wuhan linked to the first reported cases of Covid-19. Chinese authorities have used that scenario to claim that the outbreak may have started in other parts of the world, a theory many experts deem unlikely. | | | CA JUDGE TOSSES HOSPITAL 340B LAWSUIT — This week a federal judge in California tossed a hospital lawsuit claiming that HHS isn’t enforcing the rules of a federal drug discount program — the latest twist in a complicated and intensifying standoff between hospitals and pharma over the so-called 340B program, POLITICO’s Susannah Luthi reports. The complaint came after a slew of manufacturers quit extending their generous drug discounts to 340B hospitals that hire pharmacies to dispense the discounted medications. The rapid proliferation of contract pharmacies as major players in the program is one reason the pharmaceutical industry has been lobbying hard for an overhaul of 340B. Drugmakers argue pharmacies are making money off of the discounts without adding value to patients. This lawsuit was led by the American Hospital Association and is one of a few efforts to try to get HHS to penalize the drugmakers. But the judge instead dismissed the case at the urging of the federal government, saying that by resorting to litigation the hospitals are short-circuiting the health agency’s own arbitration system. (The Trump administration last month finalized new rules to adjudicate disputes between the pharmaceutical companies and hospitals over the discounts.) This decision leaves the thorny issues for Biden’s administration to deal with, just as HHS secretary designate Xavier Becerra gears up for his confirmation hearings before he can take the agency reins. Democrats have typically been hospital allies in the lobbying wars over 340B, and Becerra has already voiced his own sympathy to their side in the current fight . Meanwhile the AHA’s general counsel Melinda Hatton says the judge has left leeway for hospitals to sue again if the administration “fails to do something tangible to hold drug companies accountable.” | | | | A MUST-READ ON CAPITOL HILL: Looking for the latest insight on the power dynamic in House GOP Leadership? Want to listen in on the whispers coming out of the Speaker's Lobby? Trying to understand what is really going on inside the cloakrooms? Olivia Beavers delivers the scoop in Huddle, our morning Capitol Hill must-read, with assists from POLITICO's deeply sourced Congress team that reveal the state of play in the House and Senate. Subscribe to Huddle today. | | | | | | | | FDA PANEL QUESTIONS BD DRUG-COATED BALLOON RISK/BENEFIT — Experts at an advisory committee convened Wednesday concluded BD’s Lutonix drug-coated balloon is not effective for treatment of patients with below-the-knee critical limb ischemia. While the majority of panelists agreed the device is safe, only three voted that the benefits of the device outweigh the risks compared to 14 who voted no (one member abstained). ADVAMED, MECOMED ANNOUNCE FORMAL RELATIONSHIP — The U.S. device lobby announced Thursday it signed a memorandum of understanding with the Middle East and Africa Medtech Association. “This MOU will make it easier to share information and exchange ideas, and we’ll be able to leverage this partnership to raise awareness and advance the international policy necessary to increase patient access to life-saving technologies,” AdvaMed CEO Scott Whitaker said. | | | |   | | | | | | FRIDAY: President Joe Biden is scheduled to visit Kalamazoo, Michigan to tour Pfizer’s Covid-19 vaccine manufacturing facility. TUESDAY: The Senate HELP committee holds a confirmation hearing for Xavier Becerra, Biden’s nominee for secretary of Health and Human Services. | | | HOW TO VACCINATE AMERICA — A historical effort to vaccinate hundreds of millions of people against the coronavirus is underway... and it’s possible it only gets harder from here. Over the next few months, the supply of vaccines will grow, but so will the barriers to getting those shots into arms. The health system will need to make a sharp pivot from vaccinating eager populations like health care workers and older adults to those who are harder to reach: the under-served, the skeptical and those who live in remote areas. POLITICO convened a “policy hackathon” — Zoom sessions in which we asked some of the sharpest public health experts from around the country to compare notes, identify emerging challenges and share the best ideas for making this complex vaccination effort work. Here’s what they had to say. | | | CANADIAN TASK FORCE FACES FIRE FOR LOW VACCINE RATE — Members of Canada’s vaccine task force took questions from parliamentarians Thursday as the Trudeau government faces criticism for a slow rollout of inoculation, Pro’s Andy Blatchford reported. Their appearance follows weeks of criticism directed at the Trudeau government after significant delivery delays, making the country lag behind many developed nations. The task force has previously chosen which vaccine candidates to preorder. A couple days earlier, witnesses at a committee hearing said some task force members had conflicts of interest because of industry ties. Experts continue to call for the force to be reappointed with tougher rules on transparency. Conservatives have expressed concerns about possible conflicts as well. FIRST VOLUNTARY COVID STUDY GREENLIT — The U.K. will begin in a month the world’s first trial of healthy volunteers being intentionally infected with coronavirus, POLITICO Europe reported. The trial, called a human challenge study, will include up to 90 people being exposed to a small amount of the variant that emerged in the U.K. in a controlled environment. The controversial study was approved by an ethics board, despite the risk that health volunteers could be exposed to a deadly disease. Remdesivir will be used for volunteers developing symptoms. The second part of the study, not yet approved, is slated to test out vaccines by administering shots to volunteers and then exposing them. NOVAVAX COMMITS TO PROVIDE 1.1 BILLION COVID-19 VAX DOSES TO COVAX — Maryland-based Novavax announced Thursday a memorandum of understanding with Gavi to provide 1.1 billion doses of its Covid-19 vaccine candidate made by the Serum Institute of India and the company through COVAX. "With this MOU in place, the vaccine candidate developed by our partners at Novavax is poised to play a significant role in [combating] COVID-19 around the world," Coalition for Epidemic Preparedness Innovations CEO Richard Hatchett said. Meanwhile, Biden is slated to tell his fellow G7 leaders that the U.S. will give COVAX $2 billion to help buy vaccines for poor countries plus another $2 billion over the next two years to help increase production and delivery. But the administration will not share any U.S. vaccine doses with other countries before its population is vaccinated first, an administration official said Wednesday. | | | Biden has decided to tap Chiquita Brooks-LaSure to helm the Centers for Medicare and Medicaid Services, where a number of Trump-era proposals to slash drug costs could hang in limbo, according to four people familiar with the decision . A veteran of the agency under the Obama administration, Brooks-LaSure is expected to shore up Obamacare, but has little drug pricing experience. Michael Ayotte is being tapped by the National Association of Chain Drug Stores to be the group’s senior vice president of pharmacy, transformation and advocacy. | | | — Taiwan’s health minister implied China may be behind BioNTech pulling the plug on a deal with the island for 5 million doses, Reuters reported. — A pharma startup backed by former Operation Warp Speed advisor Moncef Slaoui raised $250 million in funds, Axios reported. — The pandemic forced numerous scientists to get creative and turn university- or hospital-based clinical trials into at-home research completed through mailed medications and video chat exams, The New York Times reported. — A 90-year-old Seattle resident trekked through 10 inches of snow for three miles to make it to her first coronavirus vaccine appointment, The Washington Post reported. | | A message from CVS Health: Throughout the COVID-19 pandemic, in communities all across the country, CVS Health has been delivering essential care. Thanks to the efforts of our employees, we’ve opened 4,800 COVID-19 test sites and administered over 15 million tests at our stores and through partners in underserved communities. With millions staying home, we are increasing access to prescription delivery, virtual visits and mental health services. Now, we’re providing vaccines in designated states and long-term care facilities. Every day, CVS Health works to bring quality, affordable health care into neighborhoods, homes and hands—so it’s never out of reach for anyone. That’s health care, from the heart. | | | | | | FDA is asking patient advocacy groups, academics and health care professionals who wish to participate in “periodic stakeholder consultation meetings” on the reauthorization of the Medical Device User Fee Amendments to let the agency know they want to attend the monthly meetings, which are slated to begin in March. A new study published in the New England Journal of Medicine found that the Pfizer-BioNTech vaccine loses some of its neutralization power against the coronavirus variant first identified in South Africa. FDA announced the renewal of the Technical Electronic Product Radiation Safety Standards Committee. FDA is requesting written comments on recommendations from WHO to impose international manufacturing and distributing restrictions on certain substances to help prepare for the United Nations Commission on Narcotic Drugs meeting in April. The Rockefeller Foundation released a hefty 87-page playbook Thursday that outlines how K-12 schools can design and implement weekly testing of students, teachers and staff. The Congressional Budget Office compared the price of branded drugs across several federal programs including Medicare Part D, Medicaid and TRICARE in a new analysis released Thursday.
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