Individuals to drive drug imports, for now

Jan 09, 2024

Driving The Day

A Canadian flag sits in front of a wall of prescription drugs in a pharmacy.

The number of prescriptions that patients fill at foreign pharmacies like those in Canada has been rising. | Jeff Haynes/AFP/Getty Images

TAKING IT PERSONALLY — Despite last week’s FDA approval of Florida’s plan to allow prescription drug imports from Canada, some drug price reform advocates say individual purchases of brand-name medicines from foreign pharmacies will still be the chief way imports bring down prices for some U.S. consumers.

The likelihood that Florida will be able to import drugs soon — if at all — is slim, thanks to several actions the state must take before the FDA will allow any pills to be shipped, as well as united opposition from Canada and the pharmaceutical industry.

Personal importation — when patients fill prescriptions with online pharmacies based abroad — has grown over the past two decades as American consumers prescribed expensive brand-name drugs run into problems affording them or accessing them under their insurance plans. Researchers estimated in 2020 that 2.3 million Americans bought their medications outside the U.S.

A ‘safety valve’: Last year, David Mitchell, president and founder of Patients for Affordable Drugs, was prescribed Eliquis, a blood thinner on CMS’ list of drugs subject to Medicare price negotiations. But his Part D plan wouldn’t cover the drug — or allow Mitchell to pay out-of-pocket for it — because he was required to try rival drug Xarelto first as part of his insurance plan’s step-therapy approach to managing costs.

“Personal importation is like a safety valve,” Mitchell told Prescription Pulse. “My plan wouldn’t give me the best drug for me.”

Definitely, maybe: The FDA says drug importation for personal use is generally illegal, but it provides guidance for individuals, citing situations when “it typically does not object to personal imports of drugs that FDA has not approved” — for example, when the drug doesn’t pose an “unreasonable risk” and the supply shipped doesn’t exceed 90 days. The agency cautions that it can’t vouch for the safety and effectiveness of drugs made and labeled abroad.

Mitchell used PharmacyChecker, a website that monitors and vets international online pharmacies’ credentials, to find a Canadian pharmacy from which he could buy Eliquis for nearly a third of the price in the U.S., he said.

Gabriel Levitt, the website’s co-founder, said the FDA’s personal importation policy doesn’t reflect the latitude Congress has given the regulator to sanction the practice.

An FDA spokesperson declined further comment.

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MEDICAL DEVICES

Medical devices are pictured.

The FDA suggests using vaporized hydrogen peroxide as an alternative to ethylene oxide when sterilizing medical devices to ward off a supply-chain shortage of the gas. | Getty Images

ANOTHER STERILIZING METHOD — The FDA said Monday it is formally classifying vaporized hydrogen peroxide as an “established method of sterilization for medical devices” to help reduce device makers’ reliance on ethylene oxide.

Dr. Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s device center, said the addition of the sterilization method will help strengthen the supply chain for sterilized medical devices.

But about 50 percent of medical devices are still sterilized using ethylene oxide, a carcinogenic gas that is the subject of pending Environmental Protection Agency regulations.

“We appreciate FDA being proactive and considering alternative sterilization modalities, but adoption and moving away from ethylene oxide as the primary sterilization method will depend on EPA’s forthcoming final rule,” said Soumi Saha, senior vice president of government affairs at group purchasing organization Premier.

FDA regulators are holding a town hall on Wednesday at 2 p.m. to discuss medical device sterilization.

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Coronavirus

GOP TEES UP FAUCI GRILLING — House Republicans are making the NIH’s research into new viruses a pillar of their grilling of former top infectious disease expert Dr. Anthony Fauci.

At issue: The House Select Subcommittee on the Coronavirus Pandemic on Monday held the first of two days of closed testimony featuring the former head of the NIH’s infectious disease center. A major topic during the hearing was Fauci’s definition of gain of function, which he says aims to make viruses more transmissible to better examine them, Robert reports.

“I don’t know that every scientist who deals with this type of viral research understands his definition of operational gain of function,” said subcommittee Chair Brad Wenstrup (R-Ohio). “People have other definitions.”

That’s something “we need to look into a little bit more,” said Wenstrup, a doctor who’s retiring after this term.

Gain of function and specifically the NIH’s role in funding such research have been consistent queries among Republicans in the past few years. Wenstrup said he would like to get Fauci “on the record” discussing more about his take on gain-of-function research.

The hearing resumes on Tuesday.

Industry Intel

PHARMA FIELD DAY AT JPM — Pharma companies are descending on the annual JP Morgan Healthcare Conference in San Francisco this week — and making a slew of announcements about their pipelines, acquisitions and more.

Of note, players in the sickle cell disease gene therapy realm provided updates on their efforts to deploy treatments to patients. Bluebird Bio said 35 of 48 treatment centers equipped to administer the therapy, Lyfgenia, are ready to accept referrals, with all facilities expected to be ready to begin treating patients with the drug by the end of the first quarter.

The company has signed outcomes-based agreements with payers covering about 200 million U.S. patients that include tracking patients for three years and has designed a Medicaid-specific offering that “addresses the need for predictability and operational ease that is essential for states grappling with resource constraints.”

Vertex Pharmaceuticals, which markets CRISPR-based Casgevy for sickle cell disease, has signed a deal with a drug-contracting organization linked to Blue Cross and Blue Shield companies covering about 100 million people. It aims to launch 50 authorized treatment centers in the U.S. and has activated nine so far.

Movers and shakers: Johnson & Johnson announced it’s acquiring cancer-focused Ambrx Biopharma. Meanwhile, Merck will acquire Harpoon Therapeutics in another cancer-focused deal.

BOSTON SCIENTIFIC TO BUY AXONICS — Boston Scientific said Monday it agreed to buy medical device company Axonics for approximately $3.7 billion.

The acquisition, which is expected to close in the first half of this year, would bring Axonics’ sacral nerve stimulation therapy for the treatment of overactive bladder and fecal incontinence to the Massachusetts medtech giant.

In Congress

BUCSHON TO RETIRE — Rep. Larry Bucshon does not plan to seek reelection this year.

The Indiana Republican — a doctor who sits on the House Energy and Commerce Committee — is the latest in a steady stream of lawmakers to announce plans to retire from Congress.

SANDERS EYES INHALER PRICES — Senate HELP Chair Bernie Sanders and some panel Democrats said Monday they are opening an investigation into the pricing of inhalers for asthma and chronic obstructive pulmonary disease made by AstraZeneca, Boehringer Ingelheim, GSK and Teva.

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Around the Agencies

HHS GETS A COMPETITION CHIEF — HHS Secretary Xavier Becerra appointed Stacy Sanders as HHS chief competition officer — a new role tasked with working with the Federal Trade Commission and the Department of Justice to address health care market concentration.

Sanders worked as a counselor to Becerra on several initiatives, including the implementation of the Inflation Reduction Act’s prescription drug provisions.

Pharma Moves

Dr. Roy Herbst is joining the board of Friends of Cancer Research. He is deputy director of the Yale Cancer Center and Smilow Cancer Hospital and assistant dean for translational research at the Yale School of Medicine.

WHAT WE'RE READING

The Supreme Court declined Monday to hear a lawsuit challenging California’s ban on the sale of flavored cigarettes, CNN’s Devan Cole reports.

The Philadelphia Health Department is cautioning that an outbreak of measles has grown to five confirmed cases and three probable cases, CBS News’ Stephanie Stahl reports.

Document Drawer

The FDA released its annual report on new drug approvals. In 2023, the agency approved 55 novel drugs.

The FDA issued a priority review voucher to Vertex Pharmaceuticals for sponsoring sickle cell therapy Casgevy.

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