News: Skirmish over paper drug info draws on

Tuesday, May 14, 2024

Skirmish over paper drug info draws on

May 14, 2024

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By David Lim and Lauren Gardner

With Megan R. Wilson

Driving The Day

A pharmacy technician helps a customer.

The FDA wants to give consumers the option of receiving the package inserts that come with prescription drugs in digital form instead of paper. | Scott Olson/Getty Images

PAPERING OVER DIFFERENCES — The long-running debate over how to present information about a drug’s use and side effects to patients and prescribers is about as complicated as the package inserts themselves.

Reps. Buddy Carter (R-Ga.) and Jared Golden (D-Maine) have co-sponsored legislation since 2019 that would require the FDA to approve a standardized, one-page format for prescription drug information — including the product’s indications, risks and interactions with other drugs or food — given to patients on paper when they pick up medications from the pharmacy.

The agency proposed doing so in May 2023, along with an option for patients to receive the information electronically. That detail has riled up a lobbying group representing the drug-information printers who back Carter and Golden’s bill.

Written warning: The Pharmaceutical Printed Literature Association said in a statement this month that the proposed rule “would implement an unproven [patient medication information] design and push PMI onto a digital, not printed, format via a QR code or website link.”

The renewed push from PPLA comes as appropriators weigh requests for fiscal 2025 spending. PPLA didn’t respond to a request for comment. The FDA, whose work on the issue dates to 2009, is reviewing comments ahead of finalizing the rule.

“The FDA recognizes the importance of providing written information to patients about their prescription drug products,” an agency spokesperson said in a statement. “Evidence suggests that such information can help patients use their prescription drug products safely and effectively.”

Carter, who’s a pharmacist, told Prescription Pulse he supports the legislation because broadband isn’t accessible to all rural Americans and older patients who might not be tech-savvy.

“I want to err on the side of making sure that people get their information … because I know how vitally important it is,” he said.

PhRMA has said the FDA should allow PMI to be provided electronically to patients to ensure they get the most up-to-date information.

The written record: Lawmakers have blocked the FDA via annual spending bills from advancing a proposal to require that prescribing information for health care professionals be delivered electronically.

Prescribing information accounts for about 30 percent of the market for thin paper, which is also used for bibles and cosmetics inserts, and one of those paper mills is in Golden’s district.

Just like a paperback novel: Not all the myriad printouts patients receive at the pharmacy — distinct from prescribing information — are FDA-approved, and those that are apply to only certain drugs.

What’s available “has been duplicative, incomplete, conflicting, or difficult to read and understand, and has not been sufficient to meet the needs of patients,” the FDA said in the proposal.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We are still upset at the cloud cover this weekend in the DMV — did you see the aurora borealis?

Send northern lights photos, news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

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In Congress

The Capitol Building.

The House Oversight and Accountability Committee will mark up the BIOSECURE Act, which would prohibit federal agencies from working with Chinese-owned biotech companies. | Susan Walsh/AP

BIOSECURE GETS A MARKUP — Legislation that would effectively prohibit Chinese-owned biotech firms from operating in the U.S. is set to be marked up in the House on Wednesday, Megan R. Wilson reports.

The action, by the Oversight and Accountability Committee, signals momentum behind the measure, which a Senate panel advanced in March.

The bill, known as the BIOSECURE Act , would prohibit the federal government from contracting with companies that have used products or services from “companies of concern,” which the legislation lists as BGI, MGI, Complete Genomics, WuXi AppTec and WuXi Biologics.

Reps. Brad Wenstrup (R-Ohio) and Raja Krishnamoorthi (D-Ill.) introduced a revamped version of the legislation last week that would give drugmakers until 2032 to move away from the “companies of concern” prompted by industry concerns that cutting ties and finding replacements would take time. It also includes a provision from the Senate version that grandfathers existing contracts with the companies.

Some of the companies, including Complete Genomics, have lobbied lawmakers to remove them from the legislation. Complete Genomics, based in California, was purchased by MGI but argues that it is fully independent with a separate corporate structure and governance.

MEDICAL DEVICES

BIDEN TARIFFS — The White House is unveiling new tariffs today on certain medical products, including syringes, needles, surgical gloves and certain personal protective equipment, to encourage domestic production of devices critical during the height of the Covid-19 pandemic.

“The tariff rates on syringes and needles will increase from 0% to 50% in 2024,” said a White House fact sheet. “For certain personal protective equipment (PPE), including certain respirators and face masks, the tariff rates will increase from 0–7.5% to 25% in 2024. Tariffs on rubber medical and surgical gloves will increase from 7.5% to 25% in 2026.”

The White House said American businesses compete with Chinese-made products that are “sometimes of such poor quality that they may raise safety concerns for health care workers and patients.”

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Coronavirus

FDA: DON’T USE CUE TEST — The FDA warned consumers and health care providers Monday not to use Cue Health’s home, over-the-counter and patient-care setting Covid-19 tests because they have an increased risk of false results.

“Consider retesting your patients using a different FDA authorized test if you suspect an inaccurate result” by a Cue Covid-19 Test, the FDA safety communication states. “If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.”

The agency issued a warning letter to the company last week following an inspection that found that the company made changes to the tests “and these changes reduced the reliability of the tests to detect SARS-CoV-2 virus.”

Pharma Moves

John Verbeten will be director of the Office of Compliance and Enforcement within the FDA’s Center for Tobacco Products. He previously served as deputy director for import operations enforcement within the Office of Enforcement and Import Operations, under the agency’s Office of Regulatory Affairs.

WHAT WE'RE READING

Melinda French Gates, the ex-wife of billionaire philanthropist and Microsoft founder Bill Gates, is resigning from the Bill and Melinda Gates Foundation, which the two have run since its founding 24 years ago, POLITICO’s Carmen Paun reports.

STAT’s Nicholas Florko profiles Cliff Douglas’ decision to take the helm of the Foundation for a Smoke-Free World, a group that is rebranding as Global Action to End Smoking. The organization took a $140 million final payment from Philip Morris International but has now pledged to not take funding from tobacco or nonmedicinal nicotine companies.

Document Drawer

The White House Office of Information and Regulatory Affairs continues to take meetings on the FDA’s menthol cigarette ban in recent days, despite the Biden administration’s delay of the final rule. The New Jersey Gasoline, Convenience Store, Automotive Association is slated to meet with OIRA on Wednesday.

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