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FDA commissioner Dr. Marty Makary is beginning to make moves toward his promise of speeding up drug approval pathways at the agency. But he’s aiming to do things a bit differently than in the past — by using vouchers to incentivize pharma companies to lower their drug costs in return for faster approvals.

This month, the FDA announced a new national priority voucher program, dubbed CNPV, that would shorten the time it takes to get a drug and biologic through the agency’s review process from 10-12 months to 1-2 months, a significant jump that could save pharma companies time and money in getting a product to market.

But it also seeks to spur drugmakers to lower their drug prices in return for the faster timeline.

On its surface, the program appears to be a win for the pharma industry as well as patients, according to Eunjoo Huisung Pacifici, chair and associate professor in the Department of Regulatory and Quality Sciences at the University of Southern California (USC).

“The regulatory review time has always been seen as an extra burden for patients who are waiting for treatments as well as for companies,” Pacifici said. “I’m all for contracting that time, as long as it’s done in a rational manner that does not jeopardize safety, efficacy or quality.”

But how the FDA will implement the program — in tandem with the larger administration’s goals of lowering drug costs — is a bit more complex.

What does the voucher program entail?

In order to be selected for the CNPV program, a drugmaker’s product must address several priorities that the FDA has lined out.

Among its first priorities is addressing a large unmet medical need and solving a U.S. public health crisis. The program also seeks products that would deliver more innovative cures for Americans, such as a novel immunotherapy or new mental health therapies.

Makary, speaking to CNBC this month in an interview, noted there would be a focus on chronic illnesses that are prevalent in America, such as diabetes and cancer. He also cited the potential of a universal flu shot, as well as more treatments for neurodegenerative diseases like Alzheimer’s.

The program also lists onshoring drug manufacturing back to the U.S. as another priority — an issue that President Donald Trump has repeatedly heralded through tariff threats. Companies that shift manufacturing of essential medicines, like generic sterile injectables, from abroad back to the U.S. would be considered for the program.

But where it gets interesting is the final priority listed on the program website — “increasing affordability.” The program would accelerate drug approvals for companies that lower the cost of a drug in general or match Trump’s Most Favored Nation pricing.

The CNPV pilot program isn’t the first time the agency has tied faster drug approvals to a larger goal. The FDA has historically relied on programs like the accelerated approval pathway, priority review designation, and breakthrough therapy designation to incentivize more therapeutic advancements in areas like rare disease and cancer.

The accelerated approval pathway, for example, was established in 1992 — partially to spur faster access to drugs that addressed the HIV/AIDS epidemic. While there are some risks and have been some controversies, such as the decision to approve Aduhelm in 2021, overall such pathways are boons for therapeutic advancements.

“There are more successes in the fast track [pathways] than there are failures, and what we’ve learned is that there is a value to a well thought-through speedier review for certain areas where it makes sense,” noted Matthew Weinberg, president of regulatory sciences at consulting company ProPharma Group.

Could the program actually lower drug costs?

The big question, however, is whether the CNPV program could actually reduce drug costs. Makary has remained stalwart in highlighting the importance of drug affordability in the program.

“The president is very adamant that he would like to see lower drug prices for Americans and he doesn’t like that Americans are getting ripped off,” Makary said in his interview with CNBC. “So we are including the affordability of drugs as a national priority.”

On one hand, some companies might find it worth it to lower drugs in return for a faster review process (it’s not clear yet how much companies would have to lower prices).

“There are companies who will definitely look at getting on the market eight to 12 months sooner, and say, ‘That’s great. I’m willing to lower the cost of my product in return for that,’” Weinberg said. “There are sponsors who will say this is a win for us.”

But both Pacifici and Weinberg pointed out that making drugs cheaper is at odds with the program’s other priority of onshoring domestic manufacturing, which would be costly for companies. That’s especially true for essential medicines and generics, which are lower-priced in the U.S. due to their low cost of manufacturing abroad. Making them in the U.S. would, inevitably, increase their cost to consumers.

Put bluntly, the CNPV list of requirements reflects the “competing priorities” of the Trump administration six months into its tenure, Weinberg said.

But there might be opportunity in the confusion. Makary’s program could potentially usher in a new era in which the pharma industry finds innovative ways to address both the domestic manufacturing issue and the problem of high drug prices.

“Policies can help change the behavior of the industry,” Pacifici explained. “This new policy may uncover innovative ways that companies can do their manufacturing [while lowering drug costs].”

Takeaways for pharma marketers

For a company — and its marketers — that has a product that could be a market leader or first to market, an extra several months could make a significant difference in securing its seat on the stage. Pointing to Humira’s peak market revenue of $20 billion a year, Pacifici noted that a company could theoretically earn billions of dollars with a few extra months on the market.

The extra earnings would differ depending on the drug, and marketers might face shorter windows to plan for launches. But they would also have more time with the drug officially on the market, be able to reach HCPs and patients faster, and advertise sooner. The CNPV program would simply be another tool to get a head start on product launches.

“If you can get to the market even two months ahead, you can secure the distribution channel,” Pacifici said. “You can secure your physicians to get a good feel and get experience in your new product. And you can secure your market share.”

The FDA has yet to lay out the regulatory process behind the two-month review, such as determining whether more staff will need to be dedicated to each review and how they’ll go about ensuring that drugs maintain safety and efficacy standards.

In order for the program to be successful, the FDA will need to provide transparency to both industry and the public, Weinberg said.

“It’s not just the industry that has to change for this. The agency has to be able to review it in a way that makes everybody safe,” he explained. “It is a two-sided coin.”