With Brianna Ehley, Emily Martin, Maura Turcotte, Victoria Colliver

— FDA after 'substantial pressure' in the Trump administration and a week of surprises.

— Biden, staff dig in on 100 million vaccines goals after confusion over federal reserves.

— California calls timeout on Moderna batch after slew of allergic reactions.

It’s Wednesday, welcome back to Prescription Pulse. Happy Inauguration Day from D.C. We hope everyone stays safe. As always, send tips to Sarah Owermohle at [email protected] or @owermohle. Loop in David Lim ([email protected] or @davidalim) and Brianna Ehley ([email protected] or @briannaehley).

FDA AFTER ‘SUBSTANTIAL PRESSURE’ IN TRUMP ADMIN — The Food and Drug Administration weathered “a clash of cultures” between the White House pressing for faster progress on vaccines and treatments and the agency’s efforts to stick to the science, outgoing Commissioner Stephen Hahn told POLITICO.

“I heard loud and clear from the White House — President Trump and others — that they wanted FDA to move faster,” Hahn said in an interview Tuesday, less than 24 hours before President-elect Joe Biden is scheduled to take office.

A string of last-minute policies from FDA’s parent, the Department of Health and Human Services, also left Hahn intermittently battling his boss, HHS Secretary Alex Azar.

Just some of the latest:

— HHS overrules FDA on animal biotech policy. The department signed on to an industry-backed plan to effectively strip the FDA of oversight of certain genetically modified animals, shifting regulatory authority to the Agriculture Department for meat and other animal products made using gene editing.

The deal announced on the last day of Trump’s presidency comes over FDA’s vehement objections, Liz Crampton and Adam Cancryn report.

"FDA has no intention of abdicating our public health mandate," FDA Commissioner Stephen Hahn tweeted Tuesday, after the USDA announced the agreement.

An HHS spokesperson said the last-minute move was driven by the White House, which coordinated a “formal policy process,” and came despite HHS Secretary Alex Azar’s own reservations.

— HHS bypasses FDA with testing review. The health department enlisted a private company to review the accuracy of some Covid-19 tests, David Lim reported this weekend.

The last-minute contract would allow HHS to use the reviews to issue emergency authorizations for tests without the FDA’s input. It’s the latest punch in the fight over lab-developed tests, after HHS stripped the FDA of its ability to require premarket review of the products.

An HHS spokesperson said the latest move was a response to labs refusing to offer Covid testing without the liability protections tied to emergency authorization.

— HHS limits directors’ terms. The department late Friday issued a final rule requiring five-year reviews for top officials at health agencies, with the possibility that they could be replaced in their roles as David and Sarah scooped last week.

It applies to longest-serving directors first; FDA’s drug chief Janet Woodcock and top device official Jeff Shuren will be up for review in December. They would be followed in subsequent years by FDA's vaccine chief Peter Marks and CDC's Director for Immunization and Respiratory Diseases Nancy Messonnier, among dozens of others. In total, 66 roles are affected.

The health department’s chief of staff, Brian Harrison, argued the “common sense” decision and dismissed concerns that the Biden administration could quickly remove the policy.

But others including four current health officials expressed alarm about the last-minute role out and concerns that five-year reviews could leave directors vulnerable to political influence in strictly health-focused roles.

What happens next: The lab test move could easily be peeled back by Biden officials, but the final rule on term limits could take time to change (if the Biden administration wants to). The animal biotechnology agreement, meanwhile, could throw regulation into further confusion while different departments work out a new compromise.

Hahn says it’s time to talk independence though he isn’t set on the best route of action. “I think given what we’ve seen over the last year, particularly in the public health emergency, really brings this issue into the fore.” Pros can read the whole Q&A here.

BIDEN, STAFF DIG IN HEELS ON 100M VACCINES GOAL — President-Elect (or by the time you’re reading this, President) Joe Biden on Friday underscored his pledge to vaccinate 100 million people against the coronavirus in his first 100 days, though he tempered expectations by noting it “will be one of the most challenging operational efforts we have ever undertaken as a nation."

Biden’s team will have “to move heaven and earth” in his plan to roll out hundreds of new vaccination sites and boost outreach to underserved minorities, he said in a speech. He is also mulling a billion-dollar national ad campaign to convince Americans to get the shot, according to two people with knowledge.

...Even after questions about the federal reserve — or lack of it. Oregon Gov. Kate Brown tweeted Friday that there is no federal reserve of coronavirus vaccines, confirming a Washington Post story that set off a firestorm of questions about just how many doses are available.

A Trump administration official said the reserve was opened to states last week, making 13 million total doses available. With government supplies now reflecting whatever is available from manufacturers, states are learning there are limits to how many people can get the first of two shots. “I guess some states thought there was going to be a big first dose increase," the official said.

A Pfizer spokesperson said the company has held back second doses for all first doses previously shipped to the U.S., and that Operation Warp Speed had asked Pfizer to start shipping second doses only recently.

"We have and are continuing to work closely with OWS on our production, release and shipping schedules – to ensure Americans receive their first and second doses of the vaccine on time," the spokesperson said. "We have provided OWS with a specific schedule and we foresee no issues in delivering on the commitments we have made."

Biden spokesperson Jen Psaki told reporters that the incoming administration still did not have a clear picture of how many doses Pfizer/BioNTech and Moderna, the two authorized manufacturers, are making and if they are hitting production targets. “There was a bit of a delay in receiving information from the outgoing administration and we’re hearing and learning about a number of issues in real time.” Psaki said.

Officials echoed Biden's optimism on the Sunday morning shows, saying that while significant work is in store to boost outreach and administration, the 100 million goal is achievable.

“We have looked carefully, and we are confident that we have enough vaccine is for the 100 million doses over the next 100 days,” Incoming CDC Director Rochelle Walenksy said on CBS’s “Face the Nation,” adding, “It will be a hefty lift, but we have it in us to do that.”

Anthony Fauci, incoming chief medical adviser to Biden, told NBC’s “Meet the Press” that “there’s no doubt about it that that can be done.”

BIDEN’S CDC CHIEF “OPTIMISTIC” VACCINES WILL HOLD UP — Walensky is “pretty optimistic” that Covid-19 vaccines will be effective against new virus variants first detected in the U.K. and South Africa, and any others that have yet to be detected. “The efficacy of the vaccine is so good and so high that we have a bit of a cushion,” she said during an interview with JAMA on Tuesday.

But she said the lack of public health laboratory infrastructure has hampered the detection of variants in the U.S. -- a position echoed by Democrat Reps. Don Beyer (D-VA) and Abigail Spanberger (D-VA) in a letter to outgoing CDC Director Robert Redfield, seeking information on the agency’s viral genetic surveillance infrastructure. They noted that while the U.K. has uploaded 151,859 individual SARS-CoV-2 sequences, U.S. labs have only uploaded 69,111 sequences.

On Covid-19 therapies…. Walensky expressed skepticism about the use of monoclonal antibodies because they are difficult to administer. “I don't think anybody thinks this is going to be the panacea for outpatient treatment. It’s just too hard.”

NATIONAL CANCER INSTITUTE TOUTS NEW SEROLOGY STANDARD — The National Cancer Institute recently announced the availability of a Covid serology standard that will allow researchers to compare the results of different studies that measure antibodies to the virus.

“If a correlate of protection could be established, it should in principle make it easier to vet new vaccines,” NCI Deputy Director Doug Lowy told POLITICO.

U.S. SURPASSES 400,000 DEATHS — The U.S. reached the grim milestone on Tuesday, less than a day before President-elect Joe Biden’s inauguration. The record comes just one month after the country hit 300,000 deaths.

IMMUNIZATION INTERRUPTUS – California health officials over the weekend told vaccinators throughout the state to stop using a batch of Moderna’s Covid-19 vaccine after a “higher than usual” number of people at one site in San Diego appeared to experience an allergic reaction to the shot, POLITICO’s Victoria Colliver reports.

The affected lot includes 330,000 doses — about 10 percent of what the state has received so far — that were sent to 287 providers statewide.

What we know: Fewer than 10 people, all health workers, reportedly had adverse reactions that required immediate medical attention. All were vaccinated at Petco Park, home of the San Diego Padres. State epidemiologist Erica Pan on Sunday evening called for halting the use of all doses in the lot out on “an extreme abundance of caution.”

What we don’t know: Whether the reactions are caused by an inherent property of the vaccine or some issue related to the site. No similar reactions have been reported by other providers who have received and administered doses from the same lot. The state, the FDA, the CDC and Moderna are all conducting investigations.

— Norway said no link had been established between Pfizer-BioNTech's Covid-19 vaccine and 33 post-vaccination deaths in the country, CBS News reported.

— Some Canadian health care workers say in an op-ed in The Star that they’re choosing to avoid posting any photos of their Covid-19 vaccinations in an effort to be cognizant of access inequities.

— The head of the World Health Organization warned that the world is on the brink of a “catastrophic moral failure” if wealthier nations don’t ensure equitable distribution of Covid-19 vaccines, The Washington Post reported.

— Eli Lilly agreed to pay Dutch biotech company Merus $1.6 billion to develop three bispecific antibodies for the treatment of cancer, Bloomberg News reported.

— Bayer’s CEO said the German biotech company is examining whether it can help CureVac to produce its experimental coronavirus vaccine, Reuters reported.

— Vanity Fair’s Katherine Eban takes a deep dive into the FDA’s response to Covid-19.

HHS Secretary Alex Azar signed a revised version of the health department’s September request for proposals for insulin reimportation and personal prescription drug importation.

HHS Secretary Alex Azar last week signed a Federal Register notice making permanent FDA’s temporary waiver of premarket notification requirements for certain artificial intelligence products. Notice of the policy change raised alarms among health technology experts, STAT News reported.