News: Appropriators: FDA must crackdown on illicit e-cigs

Friday, July 12, 2024

Appropriators: FDA must crackdown on illicit e-cigs

Jul 12, 2024

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With Ben Leonard

Driving The Day

Andy Harris exits the Capitol.

Rep. Andy Harris blames the White House for a delay in regulating the import of illegal e-cigarettes. | Francis Chung/POLITICO

CONGRESS TAKES AIM AT ILLICIT E-CIGS — Senate and House appropriators are ordering the FDA to target illegal disposable e-cigarettes — demonstrating the bipartisan ire at the flood of products being imported from China without agency authorization.

But the two chambers are wielding different sticks in committee-passed funding bills that aim to ensure the FDA takes a number of actions such as expanding prioritized enforcement to flavored disposable e-cigarettes and requiring foreign manufacturer registrations.

In the Democrat-controlled Senate, lawmakers aim to withhold 10 percent of funding for “other activities” within the FDA’s salary and expenses bucket.

But the GOP-controlled House wants to halt agency rulemaking that would ban menthol cigarettes and flavored cigars — or restrict nicotine levels in cigarettes — until the agency tackles several requirements.

That House approach drew fire late Wednesday night from Democrat appropriators, who slammed the move as a handout to the tobacco industry. But Republicans rejected an amendment seeking to strip the language, saying the Biden administration had an opportunity to move forward with regulations.

“Go after the illicit products first instead of new rulemakings on nicotine levels or menthol that, candidly, could have been finalized a year ago if the White House thought it was the right policy or the right politics,” Rep. Andy Harris (R-Md.) said Wednesday. “The delay is their decision.”

Rep. Steny Hoyer (D-Md.) told Prescription Pulse he didn’t think the House language would derail the House FDA funding bill.

“I hope it is taken out,” Hoyer said. “It’s not a poison pill ... it’s not like some of the poison pills that were stripped last year that I think will be stripped this year.”

It remains to be seen how the chambers will reconcile differences between the two approaches. Rep. Rosa DeLauro (D-Conn.), ranking member of the House Appropriations Committee, argued the House language is detrimental to public health.

“It was not going to get removed in this environment,” DeLauro said after the committee markup. “It doesn’t end here, I would think there would be the opportunity to get it out.”

A spokesperson for Sen. Dick Durbin (D-Ill.), a vociferous tobacco industry critic, blasted the House approach as “a gift to Big Tobacco.”

“Senator Durbin believes that Congress should reject the House’s reckless approach and is hopeful that the teeth in the Senate language will finally get FDA off the sidelines to stop all unlawfully marketed e-cigarettes from being peddled to kids,” the spokesperson said.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Can we petition to move the capital of the U.S. to a cooler location with less humidity?

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

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Support the 340B PATIENTS Act The 340B PATIENTS Act eliminates harmful big pharma restrictions on 340B savings that are vital for expanding health care and support for patients and rural communities in need. By restricting 340B pharmacy partnerships, drugmakers have siphoned billions from the health care safety net solely to bolster their profits. The 340B PATIENTS Act stops this damaging behavior. We call on Congress to support this vital legislation. Learn more.

In Congress

FDA logo is shown.

An FDA funding bill has been advanced by the Senate Appropriations Committee. | Jacquelyn Martin/AP

FDA SPENDING ADVANCES IN SENATE — The Senate Appropriations Committee unanimously approved legislation Thursday that would steer $6.87 billion to the FDA in fiscal 2025.

The bill would direct $3.54 billion in discretionary funding to the agency — a $22 million bump over current spending — with the remainder coming from industry user fees, committee Democrats said.

The Senate legislation would provide slightly more funding for the FDA than its House counterpart, which comes in at $6.75 billion in combined spending. House appropriators approved their fiscal 2025 bill Wednesday night in a 29-26 vote.

Incremental bumps: The Senate measure would increase funding over fiscal 2024 levels for a handful of agency priorities, according to Chair Patty Murray’s (D-Wash.) office:

— $1 million increase for cosmetics oversight

— $3 million bump for the Neurology Drug Program

— $1 million increase for antimicrobial research

— $2 million in new funding for the newly announced joint FDA-Justice Department Tobacco Task Force

SENATE PASSES DRUG PATENT BILL — The Senate on Thursday approved by unanimous consent legislation aimed at stopping drug manufacturers from gaming the patent system to stifle biosimilar competition, Ben reports.

The bill, the Affordable Prescriptions for Patients Act from Sen. John Cornyn (R-Texas), would restrict how many patents a pharmaceutical company can dispute during the “patent dance” process.

That process was established in 2010 to speed up the patent litigation process before a biosimilar product was introduced. There aren’t limits on how many patents a brand-name biologic manufacturer can assert during the dance, which supporters say enables abuse.

Changes: The legislation was amended to cut a “product-hopping” prohibition, which drew scrutiny from brand-name drug lobby PhRMA. The product-hopping strategy allows companies to try to move demand for a brand-name drug with impending generic competition to a different brand-name drug that doesn’t face such competition. The industry had argued the legislation would “upend the biopharmaceutical innovation ecosystem” and that R&D post-FDA approval bolsters patients’ treatment options.

The Congressional Budget Office last month estimated the legislation — before the product-hopping prohibition was cut — would reduce the federal deficit by more than $3 billion over 10 years. Without that provision, the CBO said it would save $1.8 billion, Cornyn said Thursday on the Senate floor.

“This bipartisan bill checks every box,” Cornyn said. “It protects innovation, it increases competition and it saves money for taxpayers and consumers.”

The legislation could be used as a potential “pay-for” in a postelection health care package.

Understand 2024’s big impacts with Pro’s extensive Campaign Races Dashboard, exclusive insights, and key coverage of federal- and state-level debates. Focus on policy. Learn more.

Industry Intel

PFIZER MOVES AHEAD ON GLP-1 PILL — Pfizer is advancing the development of a once-daily oral GLP-1 drug that could compete with weekly injections already on the market to treat obesity, the company said Thursday.

Pfizer plans to conduct studies this year evaluating different doses of a modified-release form of its investigational drug danuglipron. Eli Lilly and Novo Nordisk dominate the GLP-1 weight-loss drug market with their weekly injections branded as Zepbound and Wegovy, respectively.

Dr. Mikael Dolsten, chief scientific officer and president of research and development at Pfizer, said in a statement that the drug has demonstrated efficacy when taken twice a day, and the company believes a once-daily oral formulation would be competitive.

Eli Lilly is also testing an oral GLP-1 drug candidate for obese adults. Novo Nordisk markets an oral GLP-1 pill called Rybelsus, but it’s only approved for adults with type 2 diabetes.

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AROUND THE AGENCIES

FTC TAKES AIM — Fresh off a scathing FTC interim report released earlier this week, the antitrust agency is poised to sue pharmacy benefit managers owned by UnitedHealth Group, CVS and Cigna, POLITICO’s Josh Sisco reports.

The pending lawsuit, which could be filed as soon as this month, would claim PBMs — the middlemen that manage prescription drugs for health insurers — pushed patients to brand-name drugs, including insulin. In recent weeks, executives and lawyers for the three companies met with the three Democratic FTC commissioners in a bid to stave off a lawsuit.

Greg Lopes with the Pharmaceutical Care Management Association, a trade group for PBMs, said they “have a proven track record of lowering prescription drug costs” and put the blame on drug companies who “alone have the power to set their list prices, and they continue to set them high.”

Express Scripts spokesperson Justine Sessions also blamed drugmakers and noted that her company’s average insulin prices are under $25.

“We will defend the use of these tools vigorously as we continue working to safeguard our clients and their members from drugmaker price gouging,” CVS spokesperson David Whitrap said.

An Optum spokesperson declined to comment.

Understand 2024’s big impacts with Pro’s extensive Campaign Races Dashboard, exclusive insights, and key coverage of federal- and state-level debates. Focus on policy. Learn more.

WHAT WE'RE READING

Tens of thousands of mpox vaccine doses that the U.S. pledged to the Democratic Republic of the Congo three months ago have still not made it to the country, POLITICO’s Sophie Gardner writes.

Finland is vaccinating at-risk farmworkers against avian flu, and some U.S. researchers think the government should do the same, KFF Health News reports.

Document Drawer

The FDA published two guidance documents containing recommendations for makers submitting dental composite resin devices and dental curing lights for review.

A message from 340B Health:

Support the 340B PATIENTS Act

340B hospitals are the backbone of the nation’s health care safety net, providing essential services to patients with low incomes and those living in rural America. 340B hospitals play a vital role in delivering 77% of Medicaid hospital care, providing 67% of the nation’s unpaid care, and offering comprehensive specialty services that otherwise might not be available. 340B helps lower health care costs and enable doctors, nurses, and pharmacists to provide expanded care for the benefit of their community—all at no cost to the taxpayer.

The 340B PATIENTS Act will end harmful drug company restrictions on 340B savings that are vital for protecting patients and communities. By restricting 340B pharmacy partnerships, big pharma has siphoned billions from the health care safety net solely to bolster its profits. The 340B PATIENTS Act stops this damaging behavior. We call on Congress to support this vital legislation. Learn more.