House lawmakers kick off FDA legislative Super Bowl

From: POLITICO's Prescription Pulse - Friday Feb 04,2022 05:02 pm

Feb 04, 2022

With Katherine Ellen Foley.

On Tap

— CDC advisers weigh recommendation for Moderna’s Covid-19 vaccine for adults after full FDA approval.

— House lawmakers kicked off the monthslong FDA legislative Super Bowl Thursday, quizzing FDA officials and industry executives on user fee agreements for brand drugs, generic drugs and biosimilars.

— The Senate HELP Committee’s top Republican is bullish on passing a pandemic preparedness bill this year.

It’s Friday. Welcome back to Prescription Pulse. “Empty corner setup. At least it’s probably sterile. Add everything. 4/10 @FDACDERDirector,” Room Rater tweeted Thursday.

Send room ratings, tips and feedback to David Lim (dlim@politico.com or @davidalim), Lauren Gardner ( lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley).

Coronavirus

CDC ADVISERS TO CONSIDER MODERNA COVID VACCINE LICENSE — CDC’s independent advisory committee on vaccines meets today to evaluate the current data on, and FDA’s recent full approval of, Moderna’s Covid-19 vaccine for adults. The seven-hour meeting is largely a formality, as the panel has already recommended the shot’s use for everyone 18 and older.

But it’ll also be a forum for updates on the myocarditis risk associated with the vaccine, according to the meeting agenda . FDA’s ongoing review of that link in teenagers, especially males, has delayed Moderna’s bid to win emergency use authorization for its shots in children.

PFIZER SEEKS COVID SHOT EUA FOR YOUNGEST KIDS — Pfizer and BioNTech began the rolling submission process Tuesday for FDA to consider authorizing the first two doses of a pediatric Covid vaccine regimen for children under 5, Lauren writes. FDA, which asked the companies to begin sending the data to regulators, has already set a Feb. 15 meeting of its external vaccine advisory panel to review the information and make a recommendation to regulators.

The tricky part here is that the companies’ clinical trial showed that two doses weren’t enough to prompt an adequate immune response in the oldest children of that age group.

MEDICARE TO PAY FOR AT-HOME TESTS IN SPRING — People with Medicare will be able to obtain up to eight free over-the-counter Covid-19 tests a month starting in early spring, the Biden administration announced Thursday. Under the plan, Medicare will directly pay certain pharmacies and other participating entities, allowing people with Medicare or Medicare Advantage to pick up the tests for free.

In Congress

HOUSE SUBCOMMITTEE CONVENES ON USER FEE REAUTHORIZATION — The House Energy and Commerce health subcommittee kicked off the monthslong congressional legislative lollapalooza of FDA user fee program reauthorizations Thursday, providing lawmakers with an opportunity to question FDA leaders and industry executives on a gallimaufry of FDA policy issues.

The user fee package — typically deemed must-pass legislation — establishes five-year programs where regulated industries provide fees to FDA in exchange for a beefed-up review workforce capable of turning around product evaluations more quickly. Congress often adornes the legislative package with other FDA legislation — a so-called Christmas tree.

Health subcommittee chair Anna Eshoo (D-Calif.) dodged a question about whether House lawmakers will attempt to pass a clean reauthorization this year, saying “whatever the case is, it has to be done.”

“I don’t have a final answer to that. I would hope that if anything is added in legislation that it would be agreed upon on both sides,” said health subcommittee ranking member Rep. Brett Guthrie (R-Ky.) when asked.

Aduhelm and the accelerated approval pathway: Lawmakers pressed Patrizia Cavazzoni , head of CDER, on the coordination between FDA and CMS, questioning why Medicare would propose to limit Aduhelm coverage to those enrolled in a clinical trial after FDA had already required a clinical trial as part of the drug’s approval. They also questioned the agency’s relationship with Biogen, Aduhelm’s maker, citing news reports that the two parties had several off-book meetings while the drug was under review.

Inspections: Rep. Peter Welch (D-Vt.) asked officials about the state of FDA inspections during the pandemic, praising remote inspection tools but questioning why they can’t be used for generic or biosimilars.

“At our center we have had some mixed results with using remote inspection technology,” CBER Director Peter Marks said. “So we are still sorting through this. Because at the end of the day, we have to ensure that the products that come out — once we say they are safe — are truly safe and manufactured with the quality that Americans have come to expect.”

BURR MAKES CASE FOR PANDEMIC PREP BILL — HELP Committee ranking member Richard Burr (R-N.C.) wants to see his bipartisan pandemic preparedness bill become law this year, capping off a 17-year Senate career in which he’s known for writing the law that launched the Biomedical Advanced Research Development Authority.

While he was optimistic about his chances Thursday during a briefing with reporters, a quick peek at the congressional calendar shows it’ll be no small feat: Lawmakers are scheduled to be in session fewer days in 2022 than last year as midterm campaign season gets underway.

Republican committee staff suggested the next work period, which stretches from March into the first half of April, as a target for moving legislation through the panel. “This is not going to move forward without a healthy amendment process,” Burr said of the measure, which is currently a 205-page discussion draft.

“I think it’s safe to say that, until Sen. [Ben Ray] Lujan comes back, there’s really going to be a lot more floor time potentially because you’re going to take a lot of contentious things off the table, so I’d like to take advantage of that time,” Burr added, referring to the New Mexico Democrat who suffered a stroke last week. “I don’t see one bench or the other being fully staffed as being make-or-break on this — I’m hopeful that this is something you go to the floor and get 90 votes for.”

WAITING FOR THE VOTES: CALIFF EDITION — Lauren caught up with a few Republicans Thursday to get an update on where Robert Califf’s nomination to lead FDA stands. The quick version: Still in limbo.

GOP undecided: Sen. Rand Paul (R-Ky.), Sen. Chuck Grassley (R-Iowa), Sen. Thom Tillis (R-N.C.)

News of Lujan’s stroke has thrown the confirmation vote’s timing into greater uncertainty. He isn’t expected back to work for several weeks, leaving Dems with just 49 members.

“The White House is working the votes, and we’ll see where we are,” committee Chair Patty Murray (D-Wash.) told POLITICO, adding she didn’t know the status of the whip count.

“Bob Califf will be confirmed,” Burr said, sidestepping an inquiry about the GOP vote count.

ICYMI: Sen. Roy Blunt (R-Mo.) told POLITICO Tuesday that he’s skeptical the White House is fully behind Califf. He’s considered one of the Republicans the administration is counting on for a “yes” vote, David and Alice Miranda Ollstein write.

Eye on FDA

FDA HIRES TOP HILL STAFFER — Acting FDA Commissioner Janet Woodcock announced Wednesday that longtime House staffer Kimberlee Trzeciak is joining FDA as its permanent associate commissioner for legislative affairs. Trzeciak has worked for the Energy and Commerce Committee since 2015, most recently as chief health adviser.

CDRH UNVEILS STRATEGIC PRIORITIES THROUGH 2025 — FDA’s medical device center Thursday laid out three areas of focus for 2022–2025: building a modern, diverse workforce; working to enhance employee development programs and improve work-life balance; and advancing health equity by encouraging diversity in clinical trials and promoting equity in access to care.

The strategic priorities report calls for FDA to have more than 50 percent of manufacturers of novel medical technologies bring their devices to market in the U.S. first or in parallel with other markets by the end of 2025. The agency also wants to be among the first-movers to act on significant safety signals from marketed medical devices.

Around the Agencies

CMS KICKS OFF MCIT 2.0 LISTENING TOUR — CMS announced Thursday it is holding two meetings to solicit feedback on potential policymaking of an “alternative expedited coverage pathway” for medical devices with “scientifically sound clinical evidence” and “appropriate safeguards.” The first meeting will be on Feb. 17 and the second on March 31.

Industry Intel

THE STATE OF AMYLOID ALZHEIMER’S DRUGS — Biogen and Eli Lilly had fourth-quarter earnings calls Thursday morning:

Biogen reported that Aduhelm brought in $1 million in the last quarter in 2021 and $3 million for the full year. It also anticipates minimal revenue from the drug in 2022 performance forecasts.

The company maintains that CMS’ proposal to limit the drug’s coverage to those enrolled in a clinical trial is far too prohibitive. “We believe the best way to address the concerns of CMS is to supplement the data from the Aduhelm Phase III studies,” said Michel Vounatsos, the company’s chief executive.

Eli Lilly announced a delay in submitting its Alzheimer’s drug candidate donanemab — which works similarly to Aduhelm — until after the end of March, citing concerns around Medicare’s draft coverage determination. Lilly expects few people would be able to access the drug even after it goes through the approval pathway because the proposed coverage would be so limited.

Pharma Moves

Bayer announced Ricardo Salazar Hernández will become chief medical officer of its consumer health unit on May 1.

Takeda’s Andrew Plump and UCB’s Iris Loew-Friedrich have been appointed as the PhRMA Foundation’s chairman and treasurer, respectively.

Quest Diagnostics CEO Steve Rusckowski will be succeeded by EVP of general diagnostics James Davis on Nov. 1. Rusckowski will still serve as executive chairman of the company’s board of directors through March 2023.

Pharma Worldwide

In submissions to the U.S. Trade Representative, both the Pharmaceutical Research and Manufacturers of America and the U.S. Chamber of Commerce raised concerns about the European Union’s pharmaceutical strategy, with PhRMA calling for Washington to put the EU on its intellectual property watch list, POLITICO Europe’s Ashleigh Furlong and Carlo Martuscelli report.

Document Drawer

FDA is proposing a rule to set national standards for wholesale drug distributors and third-party logistics providers.

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