News: Cures 2.1 during a Trump admin?

Tuesday, December 24, 2024

Cures 2.1 during a Trump admin?

Dec 24, 2024

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By David Lim and Lauren Gardner

PROGRAMMING NOTE: We’ll be off for the holidays but back to our normal schedule on Tuesday, Jan. 7.

Driving The Day

Rep. Diana DeGette confers with an aide on the House dais.

Rep. Diana DeGette hopes to add new policies to the Cures 2.0 Act next year, but first she needs to find a Republican colleague to help her push them through. | Francis Chung/POLITICO

DeGETTE SEARCHES FOR NEXT CURES PARTNER — Rep. Diana DeGette (D-Colo.) is again searching for a Republican co-champion to help take a second swing at passing a second iteration of the landmark 21st Century Cures Act.

The lawmaker — expected to be the top Democrat on the House Energy and Commerce Health Subcommittee next year — and retiring Rep. Larry Bucshon (R-Ind.) released a laundry list of policies for a so-called Cures 2.1 this morning.

“Although one of us (L.B.) is leaving Congress at the end of this year, this is meant to be the start of a longer process to develop legislation that builds on the Cures 2.0 to achieve our shared goals,” DeGette and Bucshon wrote.

The new slate of ideas is intended to supplement incomplete policies in their Cures 2.0 legislation, which included provisions like the creation of the Advanced Research Projects Agency for Health passed into law as part of other legislative packages in recent years.

With Republican control of the White House and both chambers of Congress, DeGette will have to find bipartisan support for the policies detailed in the white paper containing the policy list. They include proposals to speed the delivery of new treatments to patients, expand access to telehealth and clinical trials, encourage data-sharing and update the FDA’s approval pathways.

Efforts to expand Medicare coverage of breakthrough medical technologies might be one of those policies — lawmakers on both sides of the aisle have supported a push to require coverage of breakthrough medical devices. DeGette and Bucshon say Medicare is positioned to encourage manufacturers to study the effectiveness of those devices after FDA approval.

“Post-approval studies should also be standardized, generally based on clinical records, time-limited, and not altogether burdensome,” said the lawmakers.

The lawmakers also say that a Cures 2.1 push should include an update to the government's clinical trial website to enable doctors to use patients’ electronic health records to find any trials they are eligible for. Extra efforts should be made to ensure barriers are removed to enable pregnant and lactating women to more easily take part in medical research.

“We believe that we should work to address financial barriers to participation in clinical trials,” DeGette and Bucshon wrote. “A study of clinical trial participants with cancer found that 48 percent paid at least $1,000 in monthly out-of-pocket costs, primarily towards non-medical expenses like transportation.”

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Enjoy this brief respite before 2025 — it’s bound to be a busy one.

Send your thoughts and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

Drug Pricing

Containers of Farxiga, Xarelto, Entresto and Eliquis.

CMS revealed on Monday how it arrived at the prices for the first 10 drugs in negotiations. | Scott Olson/Getty Images

CMS QUIETLY DROPS DRUG NEGOTIATION REPORTS — The Biden administration is clearing the policy decks before President-elect Donald Trump takes office, releasing its explanation of the first Medicare drug price negotiations months ahead of schedule.

The release was quickly panned by the Pharmaceutical Research and Manufacturers of America, who slammed the price explanations as “opaque.”

“The so-called ‘explanations’ for the prices set by CMS further confirms that this was a highly politicized process that prioritizes the government over individuals and their doctors, said PhRMA spokesperson Megan Van Etten. “The next Congress has a chance to fix this deeply flawed policy and preserve medicine access and innovation.”

The documents include redacted data submitted by each pharmaceutical company and explain how CMS came to a maximum fair price for each of the first 10 drugs.

“CMS negotiated prices with manufacturers of these drugs in good faith on behalf of the millions of people with Medicare, who rely on these drugs for their health and well-being,” a CMS spokesperson said in a statement.

Those prices, unveiled in August, kick into effect in 2026. The Biden administration said at the time the price talks would save the government $6 billion when the prices took effect and Medicare beneficiaries roughly $1.5 billion in out-of-pocket costs.

Eye on the FDA

FDA FINALIZES ANOTHER OTC AVENUE — The FDA finalized on Monday a rule to expand the types of nonprescription medications available to consumers, allowing for an “additional condition” for use beyond the standard labeling intended to be simple enough for people to understand without help from a provider.

The agency envisions that drugmakers would leverage the rule to develop products that could be sold without prescriptions if consumers complete an online questionnaire to determine whether the medication would be right for them, though manufacturers would have the flexibility to develop those “additional conditions.” The drugs wouldn’t technically be over-the-counter products, the FDA said, but they could be deemed safe and effective for people to use without the supervision of a doctor or pharmacist.

“FDA recognizes the potential benefit of providing consumers with access to additional types of nonprescription drug products, such as some drug products that are currently available only by prescription and that treat certain chronic diseases or conditions,” the agency said in the rule.

AROUND THE AGENCIES

ITC RULES IN LILLY’S FAVOR ON ‘KNOCKOFF’ IMPORTS — The U.S. International Trade Commission ruled Monday that several foreign and domestic entities were importing illicit tirzepatide products, violating Eli Lilly’s trademark or amounted to falsely reporting the drugs’ place of origin.

The commission found that seven entities in China and Spain — and in Florida, Iowa and Texas — violated federal law because their practices could deceive consumers. Lilly alleged the products were passed off as genuine Lilly drugs — Mounjaro and Zepbound for diabetes and weight loss, respectively — that had been clinically tested or that they contained tirzepatide when they didn’t.

Lilly said in a statement that the order puts U.S. Customs and Border Protection on notice to stem illegal tirzepatide imports.

It’s “an important step toward stopping bad actors who put patients at risk and it validates the serious concerns that Lilly has long raised about counterfeit and compounded tirzepatide knockoffs,” Patrik Jonsson, executive vice president of Lilly Diabetes and Obesity, said in a statement.

Document Drawer

The FDA released a literature review Monday of metals in tampons, which didn’t identify safety concerns.

The FDA approved Monday the first generic for an injection to lower blood sugar in people with type 2 diabetes.

On Friday, the FDA approved Novo Nordisk’s Alhemo for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 and older with hemophilia A or hemophilia B with certain inhibitors.

WHAT WE'RE READING

Vaccines given to protect infants and older adults against respiratory syncytial virus are becoming more widely accepted by the American public since they became available in 2023, according to a new survey by the University of Pennsylvania’s Annenberg Public Policy Center.

Louisiana’s health department directed employees to stop promoting vaccines against Covid-19, flu and mpox, WWNO’s Rosemary Westwood reports.

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