— Demand for FDA action amid shuffle as industry speaks up.
— Trump contradicts vax timeline … again.
— Heritable gene editing still isn’t safe, says international commission.
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EYE ON FDA
DEMAND FOR FDA ACTION AMID SHUFFLE — Ongoing fallout at the FDA over convalescent plasma and a communications team shakeup unleashed more demands from congressional Democrats for Commissioner Stephen Hahn — and CDC Director Robert Redfield, dealing with criticism of his own agency for shifting testing guidelines — to testify.
News last week that Associate Commissioner for External Affairs John “Wolf” Wagner was leaving FDA — scooped by POLITICO’s Dan Diamond — followed just days after Emily Miller was ousted from her 11-day role as top agency spokesperson by Hahn.
It was the latest in a “tit for tat” battle over communications strategy pitting Hahn, struggling to soothe the public about FDA independence, against HHS Secretary Alex Azar.
“Wolf is a very nice man — zero FDA experience,” said one senior health official. “He has made it very clear that he does not take direction from Hahn.”
Wagner is taking a new role with the assistant secretary for preparedness and response at HHS. Former commissioners Scott Gottlieb and Robert Califf swiftly applauded the return of career staff (at least for now) to top communications roles.
Congressional Democrats aren’t satisfied. Senate HELP ranking member Patty Murray (D-Wash.) and Democratic Leader Chuck Schumer pressed Hahn and Redfield to testify before the committee ASAP (they are slated for the 23rd right now.)
“After so many examples of political interference at FDA and CDC over the past few weeks, we shouldn’t let several more weeks pass before we get answers,” they wrote last week.
Industry is also piping up about independence. Vaccine makers are banding together to release a safety pledge, the Wall Street Journal reported late Friday. Leaders of biotech lobby BIO on Thursday also released an open letter on how to build public trust in Covid-19 treatments and vaccines. The outline included calls for companies to make data transparent and available — and for the FDA to “maintain its historic independence as the gold-standard international regulatory body, free from external influence.”
The American Medical Association also weighed in: “To help physicians promote vaccine confidence among their patients and the general public, we must start now to provide information, education, and transparency around the FDA’s process for authorization or licensure…” the doctors’ group wrote to Hahn.
TRUMP CONTRADICTS HEALTH OFFICIALS ON VAX TIMELINE, AGAIN — President Donald Trump again suggested that a coronavirus vaccine would “probably” be available in October, contradicting assessments this week by top health officials who have said it would be very unlikely.
The president’s remarks came a day after Operation Warp Speed chief Moncef Slaoui said that the government was “very unlikely” to greenlight a vaccine by early November.
“There is a very, very low chance that the trials that are running as we speak could read before the end of October,” Slaoui told NPR. “I think it’s extremely unlikely but not impossible, and therefore it’s the right thing to do to be prepared in case.”
He is not alone in urging caution. Anthony Fauci said the sameday that results could take longer.
“If you look at the projection of the enrollment and the kinds of things you’ll need to get a decision about whether the vaccine is safe and effective, most of us project that that’s going to be by November and December, by the end of this year,” Fauci said on CNN.
… Both Slaoui and FDA’s top vaccine official Peter Marks have said they would quit their jobs if a shot was rubber-stamped without enough data.
FDA: TRUMP-BACKED OLEANDRIN IS NOT A DIETARY SUPPLEMENT — Last month, the president expressed enthusiasm for the FDA to allow the extract from the oleander plant to be marketed as a dietary supplement and potentially as a Covid-19 treatment. But the extract, known as oleandrin, is not a dietary supplement, the FDA concluded in a letter released last week. That means it cannot be marketed immediately.
The FDA’s letter to Phoenix Biotechnology, which has discussed oleandrin with Trump previously, said the extract has been authorized for “substantial clinical investigations,” meaning it’s excluded from the definition of a dietary supplement. The agency also took issue with the company’s application and the information submitted on the extract’s safety. If Phoenix decides to develop oleandrin as a Covid-19 treatment, the company would need to run clinical trials.
COMING UP IN PHARMA
TODAY to THURSDAY: Research! America holds its annual health research forum. NIAID Director Anthony Fauci speaks today, and HHS Secretary Alex Azar, NIH Director Francis Collins and CDC Director Robert Redfield speak Wednesday.
PFIZER CEO: VACCINE DATA READY IN LATE OCTOBER — Pfizer CEO Albert Bourla said last week that the company will know if its coronavirus vaccine works by the end of October. An application for emergency use authorization or approval could be submitted shortly after that data is reviewed.
A Pfizer spokesperson told Prescription Pulse that the FDA is reviewing the trial data in real time “so the agency can evaluate at the earliest possible time whether the safety and efficacy threshold has been met.”
Pfizer had enrolled 23,000 people in its Phase III trial as of last Wednesday, 6,000 of whom have received both doses of the vaccine as of Friday, and the company is shooting for 30,000.
FIRST IN RXPULSE: COULD THE REBATE RULE WORK? The president’s executive order for CMS to finalize a rule eliminating rebates that drugmakers pay to pharmacy benefit managers had one big caveat — the rule cannot raise seniors’ premiums, out-of-pockets costs or federal spending.
That’s an impossible bar to clear, writes Alex Brill, an economist with Matrix Global Advisors and a fellow at the American Enterprise Institute, in a new report sponsored by the PBM lobby Pharmaceutical Care Management Association.
The original rebate rule, withdrawn last year, projected a nearly $200 billion increase in federal spending over a decade, plus slight premium hikes for seniors.
“Numerous analyses have shown that it would not be possible to fulfill the Executive Order’s mandate not to increase federal spending, Medicare beneficiary premiums, or patients’ total out-of-pocket costs,” Brill writes.
ICYMI: HIGHLIGHTS FROM LAST WEEK
The CDC is urging states to be ready for vaccine distribution by Nov. 1.
— At least 38 hospitals in 12 states reported shortages of Gilead’s coronavirus drug remdesivir since early July, according to Public Citizen. The watchdog group’s report shows how some states hit hard by the virus and with more new hospitalizations often received less remdesivir.
— Front-line health care workers, first responders and Americans with risky medical conditions would be among the first to receive prospective coronavirus vaccinations under a four-phase plan released by a U.S. advisory panel.
— Senate Democrat Dick Durbin sent letters to all of the companies with a vaccine candidate funded in part by Operation Warp Speed and asked how they plan to stand up to White House political pressure.
— NIH last week released $129.3 million to nine companies to help speed the development of new coronavirus testing technologies, including portable devices to aid in rapid testing.
— The Pentagon announced five military medical sites will take part in AstraZeneca’s Phase III trial.
PHARMA IN THE STATES
CUOMO: VAX BY FALL WOULD BE ‘MIRACLE DRUG’ — New York will not endorse the use of a federally backed Covid-19 vaccine until it has undergone a review by state health officials, Gov. Andrew Cuomo said Thursday.
“It’s going to be an Election Day miracle drug,” he said sarcastically during a morning conference call with reporters.
Cuomo, who has criticized Trump’s handling of the pandemic, expressed skepticism that a safe vaccine will be ready this fall, particularly by the Nov. 3 election, POLITICO New York’s Shannon Young reports.
CALIFORNIA: FIRST-OF-ITS-KIND GENERIC LAW GOES TO GOV — A bill that would allow California to potentially contract with drug companies to produce and distribute medications under its own generic drug label is on Gov. Gavin Newsom’s desk after a vote last week.
CA SB852 (19R) would require the California Health and Human Services Agency to ultimately enter into partnerships to produce or distribute generic prescription drugs and at least one form of insulin, writes POLITICO’s Victoria Colliver. It would have until July 2023 to deliver a report on the viability of direct manufacturing.
The bill has no opposition. The Association for Accessible Medicines, which represents the generic drug industry, didn’t formally oppose the measure but did have concerns that it would allow the state to produce new generic drugs before other companies had the chance.
HERITABLE GENE EDITING STILL NOT SAFE — Human genome editing that alters the characteristics of future generations shouldn’t be permitted in humans on safety grounds, according to an international commission.
In the landmark report the group — comprising the U.K.’s Royal Society, the U.S. National Academy of Medicine and the U.S. National Academy of Sciences — found that no genome editing technology has shown that it can make precise changes to the genome without introducing undesired changes, writes POLITICO Europe’s Ashleigh Furlong.
Only once this criterion is met should countries consider allowing human embryos with edited genomes to be used to create a pregnancy.
The commission was formed in the wake of the scandal surrounding Chinese scientist He Jiankui, who said in 2018 that he had edited the embryos of twin girls to make them immune to HIV. He was later sentenced to three years in jail.
Russian scientists have finally published initial results for early trials of the vaccine approved by the government last month, AP News reports.
Moderna is slowing enrollment of the massive phase III trial for its Covid-19 vaccine candidate to ensure it has sufficient representation of minorities most at risk for the disease, the company’s CEO told CNBC.
Robert Dubois will be interim president and CEO of the National Pharmaceutical Council after Dan Leonard stepped down to take over at the Association for Accessible Medicines. Dubois is NPC’s chief science officer.
FDA is set to hold a virtual public meeting on Oct. 27 to discuss the next round of medical device user fee amendments.
Roche announced Friday it received an emergency use authorization from FDA for a diagnostic test that can screen for both Covid-19 and flu.