Politico Prescription Pulse: CDC advisers hold off on Covid booster shot call
— CDC vaccine advisers balk at recommending Covid shot boosters while supporting continued availability of Johnson & Johnson’s shot.
— House Energy and Commerce Committee leaders want answers from FDA about the status of foreign inspections of drug manufacturing facilities.
— Biogen’s R&D chief defended FDA’s approval of Aduhelm and the accelerated approval process.
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CDC VACCINE ADVISERS LOOK TO FDA FOR CUES ON COVID BOOSTER SHOTS — An expert advisory panel says it can’t recommend booster shots for patients with compromised immune systems until the FDA updates its authorization for Covid-19 vaccines or fully approves the shots.
“Our hands are really tied with the current regulatory situation,” Camille Kotton, an infectious disease specialist at Massachusetts General Hospital and member of the CDC panel, said at the meeting.
Dearth of data: People with compromised immune systems resulting from advanced or untreated HIV, organ transplant recipients or certain cancer treatments have lower antibody protection from Covid-19 vaccines, and these individuals tend to get more severe cases of Covid-19. But so far, clinical trials have only featured dozens of these patients — which is not enough yet for FDA to update its emergency use authorizations. These studies are ongoing.
What FDA says: “FDA is working as rapidly as possible to conduct a thorough and comprehensive review of all regulatory submissions for Covid-19 vaccines with the goal of ultimately approving safe and effective Covid-19 vaccines for use in the US,” said Doran Fink, a deputy director of the agency’s division of vaccines and related products. He added that FDA is also exploring all possible regulatory routes that could provide additional access to vaccines in situations where data suggests that benefits outweigh the risks.
In the meantime: Members of the vaccine advisory committee stressed that immunocompromised people should continue to wear masks, stay at least six feet away from people outside of their households and avoid crowded areas. It also encouraged those interacting regularly with immunocompromised individuals to get vaccinated.
ADVISERS STAND BY J&J SHOT AMID SIDE EFFECT RISKS — The CDC vaccine panel spent most of the meeting focused on the latest rare-but-serious side effect, Guillain-Barre syndrome, to plague Johnson & Johnson’s Covid-19 vaccine. The committee largely agreed that the single-dose shot should remain on offer to Americans under current recommendations, though two of its 15 members signaled concerns with its risk profile compared to the two-dose mRNA vaccine regimens from Pfizer and Moderna, Lauren reports.
The big takeaway: Guillain-Barre and the blood-clotting condition known as TTS also linked to the J&J shot can each be serious, but the data show that thousands of Covid-19 cases, hospitalizations and deaths are averted for every handful of GBS and TTS cases. Having a single-dose option is crucial to getting more people vaccinated, especially those who would have a hard time accessing a second shot. Plus, some populations may be more concerned with the myocarditis risks of the mRNA shots and prefer the J&J option.
Eyes emoji: Two J&J officials gave a surprise, brief presentation midway through the meeting to reiterate the company’s early findings that the vaccine effectively protects recipients from several variants of concern, including Delta. Their data, which included information on T-cell response post-vaccination, appeared to push back against a lab study released this week that suggested it isn’t as effective against the highly transmissible variant as the Pfizer and Moderna shots.
Mum on boosters: Joseph Wolk, J&J’s executive vice president and chief financial officer, demurred when asked on the company’s second-quarter earnings call on Wednesday whether and when a booster shot may be needed for those who received the company’s vaccine. “Whether it’s needed or not, I think we should really defer to health officials around the world as to what that call will be,” he said. He added that data from the company’s two-dose study isn’t expected until “late Q3, early Q4 at this point.”
As of the morning of July 21, 68.4 percent of American adults had received at least one dose of a Covid-19 vaccine, according to the CDC. But the number of doses administered has plummeted since mid-April to below a half-million per day. | Annette Choi/POLITICO
AHIP RAISES ALARM OVER OUT OF NETWORK COVID TEST PRICES — Health insurer lobby AHIP on Tuesday released a report calling on Congress to set a “reasonable market-based pricing benchmark” for Covid-19 tests delivered out of network. An AHIP survey found that 27 percent of Covid-19 tests in March 2021 were out of network, up 6 percent since early in the pandemic.
A spokesperson for the American Clinical Laboratory Association, which represents commercial labs like Quest Diagnostics and Labcorp, said member lab list prices for PCR Covid-19 tests “currently range from $82-150.”
E&C LEADERS ASK FDA WHEN FOREIGN INSPECTIONS WILL NORMALIZE — The leaders of the House Energy and Commerce Committee on Thursday asked FDA when its foreign inspections will return to normal levels and if the backlog of inspections caused by the pandemic will harm the agency’s ability to make drug approval decisions.
“FDA estimates that, given the length of time required to plan foreign inspections, no foreign surveillance inspections conducted by inspectors traveling from the U.S. will be achievable before September 2021 using U.S.-based staff,” an FDA spokesperson told POLITICO, adding the agency plans on directly responding to the lawmakers.
FDA leaders have outlined how the agency plans to use voluntary remote evaluations of firms to help support medical product applications and meet user fees obligations, but lawmakers appear to be questioning if they can serve “as a full substitute for an in-person inspection.”
The lawmakers are asking FDA Acting Commissioner Janet Woodcock if the agency can rely on inspections by foreign regulators with whom the agency has a Mutual Recognition Agreement to partially or fully substitute for an in-person inspection by agency staff.
WARREN, GRASSLEY PUSH UNIQUE DEVICE IDENTIFIERS IN MEDICARE CLAIMS — Several senior lawmakers on Wednesday asked HHS Secretary Xavier Becerra to “expeditiously take steps” to add unique device identifiers to Medicare claims forms, a step they argue will boost patient safety and improve data on device outcomes.
“Doing so will improve safety and quality of care for millions of patients that rely on medical devices. It will also enable more efficient tracking of medical device outcomes, saving lives and money throughout our nation’s healthcare system,” wrote Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) and Reps. Bill Pascrell (D-N.J.), Brian Fitzpatrick (R-Pa.) and Lloyd Doggett (D-Texas).
BIOGEN’S HEAD OF RESEARCH DEFENDS ADUHELM APPROVAL — Biogen countered criticisms of its Alzheimer’s therapy approved in June in an open letter published by Alfred Sandrock, the company’s head of research and development. “Unfortunately, Aduhelm’s approval has been the subject of extensive misinformation and misunderstanding,” he wrote in the letter published Thursday. Sandrock went on to explain the FDA’s accelerated approval process, the data the agency required from Biogen, and the company’s goal that “physicians have accurate and complete information” about Aduhelm.
AROUND THE AGENCIES
CMS HOLDS FIRST PUBLIC HEARING ON ALZHEIMER’S DRUG — The fight over Biogen’s Alzheimer’s drug Aduhelm spilled over in a meeting Thursday about whether Medicare will cover the pricey treatment whose benefits have not been proven.
Representatives from Alzheimer’s advocacy groups argued that Aduhelm — and future similar therapies — should be covered at the national level. These therapies, though not cures for Alzheimer’s disease, appear to at least slow down its progression, they argued, which could result in patients delaying the onset of severe symptoms. “That time [with loved ones] is priceless,” said Maria Carillo, the chief science officer of the Alzheimer’s Association.
Other clinicians disagreed, citing Aduhelm’s lack of real-world evidence, side effects and $56,000 per year cost. “The FDA erred in approving this drug, CMS has the chance to do the right thing for public health by denying coverage,” said Adriane Fugh-Berman, a pharmacologist and physiologist at Georgetown University.
CMS’s decision could potentially set a national standard for other insurers. A follow-up hearing is scheduled for July 27, and the agency’s final decision is expected within nine months.
CANCER TEST DEAL ON THE ROCKS — DNA sequencer Illumina wants to settle the FTC’s challenge to its proposed merger with cancer testing startup Grail; the agency isn’t interested. Illumina CEO Francis deSouza said the company has offered a 12-year commitment to provide equal access to its DNA sequencing technology and to cut prices by 40 percent by 2025 to alleviate FTC concerns that it would impede Grail’s rivals. But the agency has rejected all settlement talks, POLITICO’s Leah Nylen reports.
“We make almost 10 times as much money by selling the sequencers to our competitors than we do from our own tests,” deSouza said in an interview. “There’s no incentive for us to foreclose” competitors. Illumina plans to offer that same settlement to EU merger regulators, who opened a 90-day in-depth probe of the merger Thursday, he said.
Spun off from Illumina in 2015, Grail developed a blood test to detect 50 types of early stage cancer using DNA sequencing. Illumina controls the market for the DNA sequencers that Grail and its rivals need for their liquid biopsy.
ASTRAZENECA COMPLETES ALEXION ACQUISITION — AstraZeneca announced Wednesday it completed its $39 billion purchase of rare disease drugmaker Alexion.
National Community Pharmacists Association CEO B. Douglas Hoey will also serve as president of the World Pharmacy Council.
Emergent BioSolutions announced Thursday that Adam Havey will become the company’s chief operating officer effective July 26.
PHARMA IN THE STATES
STATES REVEAL SETTLEMENT FROM OPIOID DISTRIBUTORS, MANUFACTURERS — Attorneys general from New York, Connecticut, Delaware, Louisiana, North Carolina, Pennsylvania and Tennessee announced a $26 billion proposed settlement with drug distributors and one manufacturer that would resolve lawsuits over their alleged roles in the opioid crisis, POLITICO’s Shannon Young reports.
New York Attorney General Tish James said the proposed agreement with McKesson Corp., Cardinal Health Inc., AmerisourceBergen Drug Corp. and Johnson & Johnson will provide up to $1.25 billion to New York for opioid addiction prevention, treatment and recovery programs.
POLITICO’s Gary Fineout reports that Florida could receive nearly $2 billion over the next two decades as part of the same national settlement.
FLORIDA GROUP MOVES TO BOOST VACCINES IN BLACK COMMUNITIES — The Florida Statewide Coronavirus Vaccination Community Education and Engagement Taskforce is amping up its lobbying effort for funding to help boost vaccination rates in the state’s marginalized communities, POLITICO’s Matt Dixon reports.
Just 25 percent of Black people in Florida are currently vaccinated, according to Bloomberg’s vaccine tracker, though that percentage is nearly double for white people.
SOUTH AFRICAN COMPANY TO HELP PRODUCE PFIZER VACCINE — BioNTech and Pfizer inked a deal with South African company Biovac to complete the final stage of the production process for their vaccine and distribute it throughout Africa, POLITICO EU’s Ashleigh Furlong reports.
Under the deal, Biovac will carry out “fill and finish” of the Pfizer vaccine starting in 2022, with their facility being incorporated into the supply chain by the end of this year. The partners hope that Biovac will be able to fill and finish over 100 million doses that would be exclusively distributed within the African Union.
Webinar: Congress and the FDA: On Tuesday, July 27, AgencyIQ will host a free webinar on upcoming House and Senate legislation and what it could mean for the FDA and life sciences industry.
E&C clears bills for a full floor vote — The House Energy and Commerce Committee on Wednesday advanced two dozen health and technology bills at a full committee markup session. One of the bills (H.R. 4369 (117)) would establish National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing, which is meant to bolster domestic production of pharmaceutical products. Another bill (H.R. 3743 (117)) would increase funding for the Reagan-Udall Foundation for the FDA, while another (H.R. 4026 (117)) would help to standardize approaches for collecting data on social determinants of health.
Real-World Evidence to support EUA transitions — A bill recently introduced in the House would allow sponsors of products authorized during the public health emergency under an Emergency Use Authorization to use data generated by the product to support full market access decisions. The FDA Advancing Collection of Transformative Science Act would explicitly permit the use of Real-World Evidence, though the use of such data may be difficult due to a variety of factors, according to AgencyIQ’s analysis of the bill. The bill has a companion in the Senate.
Doctors hail intrauterine devices as one of the most effective forms of birth control — yet are often mum about the excruciating pain around their insertion many users experience. The result? Many users feeling shocked, duped or unheard when they bring their concerns to health care providers, Caroline Kitchener writes for The Lily.
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FDA’s Woodcock writes in a Wednesday blog that the agency needs additional authorities to learn about and address medical device shortages outside a public health emergency.
The FDA is requesting applications from patient advocates to participate in the Clinical Trials Transformation Initiative and agency’s Patient Engagement Collaborative.
FDA issued an EUA to BD allowing the company to make its sodium citrate blood specimen collection tubes at its United Kingdom manufacturing site. The tubes, which are used to collect and transport blood samples for coagulation testing, are on the agency’s device shortage list.