|
Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Lauren Gardner and David Lim | Presented by CVS Health | With Katherine Ellen Foley and Emily Martin | | | — President Joe Biden announces his directive to federal employees: Either get vaccinated against Covid-19 or submit to regular testing. — Pfizer plans to submit booster shot data to regulatory authorities: Third shots appear to boost antibody responses and provide some protection against the Delta variant. — FDA’s Richard Pazdur mounts a defense of the agency’s accelerated approval program. It’s FRIDAY, welcome back to Prescription Pulse. Your authors are wondering if a Prescription Pulse reader bought Martin Shkreli’s Wu-Tang Clan album from the U.S. government. Be sure to send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). | | A message from CVS Health: Throughout the pandemic, in communities across the country, CVS Health has been there. We’ve opened more than 4,800 COVID-19 test sites, administered more than 23 million tests and given nearly 24 million vaccine doses. We’ve expanded access to prenatal and postpartum care via telemedicine, increased remote access to mental health services and invested in affordable housing to help build healthier communities. We’ve been on the frontlines, making health care easier to access and afford. Learn more. | | | | | | BIDEN UNVEILS VACCINE-OR-TEST DIRECTIVE FOR FEDS — The president spent much of his East Room speech Thursday pleading with unvaccinated Americans to get their shots as the Delta variant fuels infection spikes across the country. If more workplaces institute similar requirements to the federal government’s, he mused, the U.S. can return to “normal” more quickly. Still, it remained unclear what it will mean for federal employees to “attest” to being fully vaccinated (for example, if they’ll have to present vaccination cards to their bosses), and how once- or twice-weekly testing requirements will work. Will testing sites pop up in federal buildings? Or will workers have to seek out their own tests? The leader of the American Federation of Government Employees, the largest union representing federal workers, said he expects the government to bring any Covid-related changes to working conditions to the bargaining table, likely to address questions like these. A White House spokesperson didn’t respond to a request for comment on whether the administration will negotiate with federal employee unions over the directive. Be on the lookout: CDC is expected to release more information today about the data it says prompted its change to mask recommendations, ABC News reports. The Provincetown, Mass., July Fourth outbreak is believed to be one of the datapoints. FDA ALLOWS EMERGENT TO RESTART PRODUCTION OF J&J COVID SHOT — FDA has told Emergent BioSolutions that it can resume making drug substance for Johnson & Johnson's Covid-19 vaccine at its Baltimore plant, the contractor announced Thursday. The agency has not formally authorized the plant, the step that would allow any new doses to be put into use, Lauren writes. A senior administration official said FDA must conduct one more inspection after production restarts to clear the facility, meaning vaccine doses likely won't be ready for distribution for six to eight weeks. PFIZER SAYS IT WILL SUBMIT BOOSTER SHOT DATA TO FDA BY MID-AUGUST — Pfizer plans to submit data on its Covid-19 booster shot to FDA by Aug. 16, CEO Albert Bourla said on an earnings call on Wednesday. More booster evidence: In the same call, executives discussed published initial data that found efficacy declined from a high of 96 percent two months after the second of two shots to 84 percent six months out. But new data from its ongoing trial of a third dose of its Covid-19 vaccine show that a booster elicits a notable antibody response, including against the Delta variant. Update on kid trials…: The company also said it expects to have enough safety and efficacy data to support an emergency use authorization application to vaccinate 5- to 11-year-olds by the end of September, with a full dataset for that age group by the end of 2021. ...And Covid-19 therapies: Pfizer confirmed it had begun a Phase II/III trial for a Covid-19 oral antiviral treatment in July; it expects results it can submit to FDA by the end of the year. CDC: VACCINATED PEOPLE SHOULD GET TESTED IF EXPOSED TO COVID — Fully vaccinated people who have spent time around someone with suspected or confirmed Covid-19 should get tested after three to five days, even if they do not have symptoms, according to updated CDC guidance published Tuesday. | | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | PAZDUR: ACCELERATED APPROVAL IS ‘UNDER ATTACK’ — The head of FDA’s oncology center on Thursday pushed back against critics of the agency’s accelerated approval program, arguing cancer drugs that have been critical for patients have been approved years before confirmatory studies were completed. “People that are unwilling to voice their support for this program may one day wake up with a much different regulatory environment, one that may be very ultra orthodox in its regulatory approach to the cancer patients and puts a p-value above the needs of cancer patients,” FDA’s Richard Pazdur said at a Friends of Cancer Research virtual event on the Cures 2.0 draft legislation. The longtime regulator argued “a failed trial does not mean a failed drug,” pointing to PD-1 therapies as one example of the success of speeding cancer drugs to market. “Some have failed their confirmatory trials and others of the same class have succeeded,” Pazdur said. “And it probably wasn't a difference of the drugs. It was just how they designed the trials.” Pazdur acknowledged “there is room for improvement” when it comes to removing accelerated approval drugs from the market when they don’t meet their primary endpoint or when standards of medicine change. “We just can't concentrate on what's wrong with the program, we also really need to address what is going right with the program,” Pazdur said. RARE DISEASE COALITION COMES TO ACCELERATED APPROVAL DEFENSE — Accelerated drug approvals allow patients with rare diseases to access novel therapies faster, the Rare Disease Company Coalition said in a letter addressed to the Senate Health, Education, Labor and Pensions Committee and the House Energy and Commerce Committee today. BUT LAWMAKERS PRESS FDA FOR MORE APPROVAL PATHWAYS FOR RARE-DISEASE DRUGS — Despite directives in the 21st Century Cures Act to make drugs for rare diseases more accessible, not enough are reaching patients, lawmakers argued in a House E&C hearing Thursday. AND THE ADUHELM FALLOUT CONTINUES — Members of the FDA’s advisory committee for neurological drugs published a new criticism of the agency’s approval of the novel Alzheimer’s therapy. Their concern: Aduhelm’s approval is based on a surrogate measure of success — reducing buildups of a protein in the brain called amyloid — which may not clinically benefit patients. “The FDA has set a worrisome precedent here and the horse is out of the barn,” Caleb Alexander, an epidemiologist at Johns Hopkins Bloomberg School of Public Health and co-author of the piece, told POLITICO. Already, two more drug manufacturers have applied to use amyloid as a surrogate measure for a drug’s success, rather than evidence of delaying or improving symptoms of the disease. Prescribing procedures: Following updates to labels and confusion about insurance coverage, many providers have been unwilling to prescribe Aduhelm to patients. A group of health care providers discussed best practices for clinicians wishing to use Aduhelm at the Alzheimer’s Association International Conference in Denver this week. The team recommended that patients only receive Aduhelm after substantial scans and potentially genetic testing to confirm the drug is appropriate for them — much of which isn’t covered by insurance. FDA APPROVES FIRST GENERIC INSULIN PRODUCT — FDA’s decision Wednesday to green-light the first interchangeable biosimilar insulin product is expected to give American diabetics access to the drug at a cheaper price after years of rising costs, Lauren writes. The agency first moved to reclassify insulin as a biologic, thus making it easier to manufacture identical forms, in late 2018. | | | HOUSE PASSES SPENDING PACKAGE WITH FDA FUNDING — The House passed a $600 billion “minibus” on Thursday that wrapped in $3.47 billion in fiscal 2022 appropriations for FDA, POLITICO’s Caitlin Emma reports. The Senate is set to mark up its Agriculture-FDA bill next week, but no one expects Congress to finish its appropriations work before Sept. 30, making a continuing resolution all but guaranteed when lawmakers return from August recess. | | | |   | | | | | | ELI LILLY PRESENTS NEW DATA ON NOVEL ALZHEIMER’S DRUG — Eli Lilly’s donanemab lowered amyloid in participants of a Phase II clinical trial, and appeared to decrease the amount of tau protein buildup over time, the company said in a presentation at AAIC. Donanemab, which the company plans to submit for accelerated approval from the FDA, works similarly to Biogen’s Aduhelm, by clearing amyloid in the brain. The company also said it saw significant decreases in disease progression in those who received the drug. | | | Cristal N. Downing will become Merck’s chief communications and public affairs officer next month. She most recently served as Johnson & Johnson’s vice president for communications and public affairs for medical devices. Joanne Duncan is joining the Association for Accessible Medicines as chief operating officer. She previously was president of the membership and business operations division at the Biotechnology Innovation Organization. | | | | Be a Policy Pro. POLITICO Pro has a free policy resource center filled with our best practices on building relationships with state and federal representatives, demonstrating ROI, and influencing policy through digital storytelling. Read our free guides today . | | | | | | | | CALIFORNIA STATE EMPLOYEE UNION PUSHES BACK ON VAX-OR-TEST REQUIREMENT — The head of California's largest state employee union sent a cease-and-desist letter to the California Department of Human Resources over Gov. Gavin Newsom’s new order requiring state workers to get vaccinated or undergo weekly testing for Covid-19, POLITICO Pro’s Victoria Colliver reports. DESANTIS PANEL OF DOCTORS REJECTS MASKS FOR K-12 KIDS — A panel of doctors Florida Gov. Ron DeSantis quietly gathered this week concluded that masks on school-age children is “abuse” and downplayed the dangers of coronavirus infections in young kids, POLITICO Pro’s Matt Dixon and Andrew Atterbury report. The panel’s assessments are at odds with federal recommendations for K-12 students the CDC recently rolled out. | 
Florida Gov. Ron DeSantis speaks during the American Legislative Exchange Council Wednesday, July 28, 2021, in Salt Lake City. | (Rick Bowmer/AP Photo) | PHARMA WORLDWIDE STUDY: BLOOD-CLOT RISK UNCHANGED AFTER SECOND ASTRAZENECA SHOT — A new study from AstraZeneca found that a person’s risk of blood clots doesn’t increase after the second vaccine shot, an effort to boost the public’s confidence in its jab, POLITICO EU’s Jillian Deutsch and Ashleigh Furlong report. ASTRAZENECA HOPES TO SETTLE EU COURT CASE IN WEEKS — A senior AstraZeneca executive hopes the EU and AstraZeneca could settle their months-long lawsuit over their ill-fated coronavirus vaccine contract in a few weeks, Deutsch reports. "We are working very close with the European Commission in order to reach a settlement," said Ruud Dobber, vice president of biopharmaceuticals. "We don't think it's useful for both parties to continue this." The European Commission declined to comment. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for the FDA. Cancer, after Covid: Three top FDA oncology officials this week released a paper outlining ways regulators can improve the development process for cancer clinical trials, based on what they’ve learned during the pandemic. Among the ideas : Routinely collecting patient-reported outcomes, sending investigational treatments to patients (instead of having them travel to a trial site), “decentralize” trials to make them more accessible to rural patients, and encourage use of community-based sites (like a doctor’s office) rather than larger clinical trial sites like hospitals. Pharmaceutical companies employed many of these methods on an emergency basis during the pandemic. Faster reimbursement for “breakthrough” drugs and devices: Legislation recently introduced in Congress would seek to update the ways that novel products, including “breakthrough” drugs and devices, can be paid for through federal programs. The New Opportunities for Value That Extend Lives, or NOVEL, Act would permit products that have been given breakthrough designation (as well as regenerative medicines) to benefit from an expedited reimbursement coding process by CMS. FDA would also be tasked with coordinating with CMS on coverage decisions for these products. AgencyIQ has an analysis of how the bill would work. | | | MedTech Strategist spoke to Medical Device Regulation panel expert Bassil Akra about the first-ever MDR opinion and the public pressures for the panel process. Olympic athletes Lee Kiefer and Gerek Meinhardt attended medical school, making them future doctors with Olympic medals, the Wall Street Journal reports. | | A message from CVS Health: At CVS Health, we’re more than 300,000 caring employees ensuring millions of Americans can access health care services.
With many still staying home, we’re supporting safer pregnancies by expanding access to prenatal and postpartum care via telemedicine.
Nothing should stand in the way of mental health and well-being, so we’re increasing remote access to mental health services.
Recognizing the strong connection between housing and health, we’re investing in affordable housing to support underserved populations and build healthier communities.
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. Learn more. | | | | | | FDA published draft guidance Wednesday outlining recommendations for drugmakers developing monoclonal antibody cocktails for rabies. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
