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FDA chief’s unwelcome message to biotech execs: ‘Prices of drugs are too high’

At the global BIO convention in Boston, Califf defended limiting reimbursements for accelerated approvals of treatments, saying they’re not fully proven

FDA Commissioner Robert Califf spoke with Rachel King, CEO of BIO, at the organization's global convention, held at the Boston Convention and Exhibition Center this week.Lane Turner/Globe Staff

The Food and Drug Administration’s top official Wednesday told a Boston gathering of biopharma industry leaders something few of them wanted to hear: Americans are paying too much for prescription medicines.

”The prices of drugs are too high in the US, and we have to come to grips with it,” FDA Commissioner Robert Califf told more than 1,000 people at the BIO 2023 convention. “People suffer health consequences [when] they don’t take their drugs because they’re trying to save money.”

At panel discussions over the past three days at the Boston Convention and Exhibition Center, executives complained about provisions in the Inflation Reduction Act, which President Biden, signed into law last year, aimed at holding down the price of medications.

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Among other measures, the law, dubbed by critics at BIO as the “Innovation Reduction Act,” ties increases in drug prices to the rate of inflation and empowers Medicare, which insures Americans over 65, to negotiate with drug makers over the price of the most expensive therapies.

“It’s something the industry’s very concerned about because of the impact on future investments in drugs,” said Rachel King, chief executive of the Biotechnology Innovation Industry, the trade and lobbying group hosting the convention, during a conversation with Califf on Wednesday morning.

Califf, who was sworn in for his second stint as FDA commissioner in February 2022, said the US drug discovery and approval process generally works “but we’ve got to tweak it, and this [law] is an effort to tweak it.” He conceded the law has “imperfections,” but said he wasn’t at liberty to offer details.

He also said FDA officials are providing technical assistance to their counterparts at the federal Centers for Medicare & Medicaid Services as they prepare to negotiate drug prices with companiesfor the first time.

A cardiologist and native South Carolinian, Califf acknowledged the contributions of drug makers, citing pandemic-era vaccines and antivirals. “Keep up the great work,” he told his BIO audience. “The people who produce good products that make a difference should be rewarded.”

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Attendees strolled the exhibition hall at the BIO 2023 convention.Lane Turner/Globe Staff

Much of the talk at the BIO convention, which drew more than 20,000 attendees, has been on stepped-up scrutiny by lawmakers and health insurers over everything from drug prices to an “accelerated approval” pathway that clears drugs filling unmet needs before clinical studies are completed.

BIO is opposing legislation that would give the FDA authority to ensure confirmatory trials are underway before granting accelerated approvals, saying it would be a burden on biotech startups. It’s also working against federal and state proposals to limit reimbursements from Medicare and state Medicaid programs for drugs cleared under the accelerated approval pathway.

The pathway is “a very successful way industry and the FDA have found to get drugs to patients more quickly,” King, who formerly led Maryland biotech GlycoMemetics, told the FDA commissioner. “But now it’s coming under attack. There’s been some risk that the pathway may be impeded.”

Califf defended accelerated approvals, which brings drugs to market three years faster on average than traditional approvals, saying they’re important to patients suffering from rare diseases that have no other treatments. He said his mother, who had multiple myeloma, lived three to four extra years and died in her 90s thanks to a medicine made available through faster approval.

“I’m totally in favor of accelerated approval when it’s a serious life-threatening condition and there’s no effective treatment,” Califf said. But he pushed back against the idea that health insurers should be required to pay as much for fast-tracked drugs as for those that win traditional FDA approval.

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“We have to face the reality that an accelerated approval is not based on clinical outcomes,” he said, noting faster approval is allowed for some drugs when regulators determine they’re “reasonably likely” to benefit patients. “By definition, there’s going to be more uncertainty with an accelerated approval.”

He also noted that some drug makers “have not done a great job in doing the follow-up studies that are required” for faster approvals.

Califf said it “sounds like common sense to me” for government health insurers to pay less for drugs that haven’t yet been fully approved.

“If I had a basketball that’s probably going to stay inflated and it looks pretty good in the store but we don’t really know, you wouldn’t really pay the same as you would for a first-rate basketball” guaranteed to stay firm, he said.


Robert Weisman can be reached at robert.weisman@globe.com.