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With Arek Sarkissian

ASPR ADDS MORE FAIR-PRICING CLAUSES — The pharmaceutical industry’s no-good-very-bad month continued on Thursday, with the Biden administration announcing that the Administration for Strategic Preparedness and Response will incorporate fair-pricing provisions into contracts.

HHS is reaching agreements similar to its September deal with Regeneron, which aimed to ensure the U.S. government and consumers don’t pay more than comparable countries. Recently, three manufacturers — Gritstone Bio, CastleVax and Codagenix — each with new Covid-19 vaccines in development, agreed to similar clauses.

“That means American families will finally pay the same as people in other countries for many of the vaccines and treatments developed or funded through their own tax dollars in the first place,” President Joe Biden said Thursday. “It’s a simple principle, you shouldn’t pay the highest price in the world for drugs that your tax dollars have already helped create.”

Industry opposition: But PhRMA CEO Steve Ubl told reporters Thursday that the effort adds to a “cloud that’s going to cause investors to take pause” and cause people “to be afraid of what the possibilities are and how it will be actually implemented in the future.”

“Collectively, this administration has one of the most anti-innovation agendas of any administration,” Ubl said.

Advocates celebrate: But drug pricing advocates, such as consumer advocacy group Public Citizen’s Peter Maybarduk, said the latest slate of policies shows the Biden administration is starting to take meaningful steps to address the prescription drug costs.

“To folks who have been fighting these battles for a long time, we feel like the administration is beginning to take more seriously its executive power,” Maybarduk said. “There’s more work left to do .. it’s ASPR, not NIH, but this is progress. This is meaningful. This is something real.”

Ubl said it is too early to say whether the industry will sue over another administration policy derided by drugmakers: last week’s draft framework on march-in rights, which involves seizing patents of certain drugs developed with public money if the government deems prices too high. But he signaled drugmakers are ready to sue if the policy moves forward.

“We hope this partisan patent heist gets withdrawn based on the comments they receive,” Ubl said. “But if they move forward and eventually exercise these rights, we’re not taking any tool off the table.”

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. The CDC is warning there is an “urgent need” to boost immunizations for the current respiratory illness season.

Send news and tips to Lauren Gardner ([email protected] or @Gardner_LM) or David Lim ([email protected] or @davidalim).

TODAY ON OUR PULSE CHECK PODCAST, host Chelsea Cirruzzo talks with POLITICO health care reporter Robert King, who breaks down the Biden administration’s efforts to curb high prescription drug prices by requiring drugmakers receiving research funding from HHS to commit to a fair price, or no higher than they charge in other countries.

FDA REG SCOPE UNDER SCOTUS REVIEW — The Supreme Court’s decision this week to consider how patients can access medication abortion puts the FDA’s regulatory authority on notice.

The high court turned down a conservative group’s challenge to the agency’s 2000 approval of mifepristone, one of two drugs used in medication abortions in the U.S. But it will weigh FDA policies set since the Obama administration that increased access to the pills, a move the pharma industry and lawyers warn could upend federal agencies’ ability to use scientific evidence to support policy decisions.

“If the FDA can’t approve mifepristone with all of the evidence that’s accumulated, I don’t know what the FDA can do,” Lawrence Gostin, a Georgetown University law professor, told Prescription Pulse.

At issue: The court will decide whether the FDA acted lawfully in 2016 when it allowed mifepristone to be used in the first 10 weeks of gestation, up from seven — when many people don’t yet know they’re pregnant. The agency’s approval of a generic in 2019 and its subsequent decisions to sanction online prescriptions, mail delivery and pharmacy dispensing of mifepristone will also be considered.

The FDA implemented those decisions, which expanded access to the drug and made it the most popular way to end a pregnancy, by updating mifepristone’s labeling and its standards governing the use of medicines with “serious safety concerns.”

Legal horizon: Legal experts like Gostin say an opinion against the FDA would set a precedent that amounts to “open hunting season for all the controversial but scientifically sound vaccines and drugs,” increasing the odds of litigation targeting specific drug approvals.

Jim Stansel, PhRMA’s general counsel, said the Supreme Court should reinforce the FDA’s power to decide which drugs are safe and effective.

“America’s regulatory framework for biopharmaceuticals hinges on that authority and that certainty is essential for patients, providers and manufacturers,” he said in a statement.

AWAITING IMPORTATION PLAN FEEDBACK — After more than three years, the FDA has now promised Florida it would decide on the state’s plan to import cheaper prescription drugs from Canada by Jan. 5, POLITICO’s Arek Sarkissian reports.

The FDA, which declined to comment when asked about the date, had initially told the Florida Agency for Health Care Administration it would rule on the proposed importation program by Dec. 19, but that date was pushed back last week, AHCA spokesman Brock Juarez said Thursday.

“They informed us it’s taking longer than expected,” Juarez wrote in a text. After two rounds of revisions, the state submitted its final copy on Oct. 16, he added.

A decision from the FDA could represent a win for Florida Gov. Ron DeSantis, who has pressed the Biden administration to approve his state’s plan.

But the pharmaceutical industry, health experts and FDA Commissioner Robert Califf have all warned that allowing drug importation could endanger public health and is not an appropriate way to lower drug costs.

“The ‘closed’ distribution system undertaken by the FDA under the direction of broadly supported drug safety legislation, provides assurance that good manufacturing practices are used and that the increasingly complex supply chain, including shipment and storage, is carefully monitored to ensure the quality and security of approved medications,” Califf and three former FDA commissioners — Margaret Hamburg, Mark McClellan and Andrew Von Eschenbach — wrote in 2017.

A lawsuit by the pharmaceutical industry that sought to block the Trump-era regulation that aims to allow states to establish importation programs was dismissed in February after a federal judge determined that harm to drugmakers is unlikely to materialize.

GOP THREATENS FDA WITH SUBPOENA — Senior House Energy and Commerce Republicans are calling on the FDA to respond to questions about the agency’s foreign inspection program or risk being subpoenaed.

Chair Cathy McMorris Rodgers (R-Wash.), Oversight Subcommittee Chair Morgan Griffith (R-Va.) and Health Subcommittee Chair Brett Guthrie (R-Ky.) gave FDA Commissioner Robert Califf a Jan. 5 deadline to answer questions and produce documents they first requested in July. They said they’re concerned that HHS “has made a deliberate decision to understaff and under-resource its ability to respond to oversight requests.”

“The FDA has received the letter and will respond directly to the representatives,” FDA spokesperson Jeremy Kahn said in an email.

FDA, CBP SEIZE E-CIG SHIPMENTS — The FDA and U.S. Customs and Border Protection intercepted unauthorized e-cigarette products worth more than $18 million, the agencies said Thursday. The seizures, part of a three-day joint operation, included brands like Elf Bar, commonly used by young people.

The operation took place at Los Angeles International Airport’s cargo site, the agencies said, and all the packages came from China. Many products were wrongly declared as other goods, such as toys.

Related: The World Health Organization has called for a blanket ban on flavored e-cigarettes, POLITICO’s Ashleigh Furlong reports. And three senators wrote to Califf this week urging an overhaul of the agency’s tobacco-product review process.

The U.S. District Court for the District of Massachusetts has entered a consent decree requiring Pharmasol Corporation and its president to stop distributing drugs until they meet current so-called good manufacturing practice requirements.

The Federal Trade Commission has finalized a consent order resolving competition concerns raised by Amgen’s acquisition of Horizon Therapeutics.

Pfizer has completed its acquisition of cancer biotech Seagen.

The FDA sent a response on Thursday to Florida Surgeon General Joseph Ladapo defending its review of the safety of Covid vaccines.