Q&A - October 27, 2025
This week’s questions:
What do you think about this past week’s stories on increased lobbying by pharma (and others) this year?
Why was your analysis (here) of the nine vouchers awarded under the National Priority Review Voucher Initiative more positive than most?
Q: What do you think about this past week’s stories on increased lobbying by pharma (and others) this year?
A: The pharma companies have been more active in DC this year, with much higher-level executives than in the past (i.e., the type that gets to use the corporate plane). This is documented in an Endpoints article by Max Bayer, who uses a highly imaginative approach to document more than 120 visits this year to DC by jets owned by top drug companies.
This activity is not surprising given the breadth of companies and institutions that are “at risk” from tax policies, tariffs, AI regulation, etc. AND the degree to which this Administration focuses on the value of personal relationships. I suspect a similar study would quantify an increase in visits this year by tech leaders and university presidents.
What impressed me most was Max’s choice to compare this year’s pharma data to 2022. “The high cadence of Washington visits by the pharma giants far outpaces travel in 2022, when the Inflation Reduction Act was being negotiated and pharma companies faced the most significant legislative effort in years to lower the cost of drugs.”
In contrast, this past week saw a spate of stories comparing 2025 lobbying spending data to 2024 data, even though it makes little sense to do so. A year ago, we were in the middle of a hard-fought presidential and Congressional election and were in the fourth year of an Administration whose chief was not running for re-election. The focus on lobbying Congress was significantly reduced.
Of course, lobbying increased substantially this year. It would be more interesting, not to mention more relevant, to compare the first year of a presidential term to the last year of the prior Administration. The amounts spent in 2021 compared to 2020, and in 2017 compared to 2016, would provide appropriate context for evaluating the 2025 lobbying spending levels.
Q: Why was your analysis (here) of the nine vouchers awarded under the FDA Commissioner’s National Priority Review Voucher Initiative (FDA Website) more positive than most?
A: In the awarding of priority reviews, “unmet medical need” has always been tied to life-threatening conditions. The nine products receiving vouchers reflect a broader definition that recognizes other types of unmet medical needs.
For example, “onshoring for economic purposes” is a national priority but not an FDA priority. However, “onshoring to address ongoing drug shortages” strikes me as an acceptable FDA priority, as it addresses an unmet medical need.
Many commentators were, understandably, turned off by all the rhetoric about how the nine vouchers met national priorities that were not necessarily FDA priorities. This administration has a high need to present almost everything as a “deal” rather than just doing the right thing and omitting the smirking. In my opinion, all of their voucher choices address unmet medical needs: 1/none are frivolous and 2/ all are legitimately on someone’s list of priority unmet medical needs.
Of the nine, five are aimed at serious diseases and conditions: deafness, blindness, pancreatic cancer, porphyria, and type 1 diabetes. While these are not all life-threatening conditions, they certainly qualify as serious unmet medical needs.
A colleague suggested to me that one of these therapies was not a good choice because the product was “less promising.” That is something I can’t evaluate. However, he didn’t deny that the disease targeted by the voucher selection qualifies as an unmet medical need.
Of the other four, one involves pricing concessions related to products for infertility. Notably, the company isn’t discounting a broad range of drugs to gain favor for one. Instead, the discounted drugs are complementary and target the same substantial unmet medical need.
Another voucher was to stimulate the development of products to counter nicotine vaping. I looked it up: nicotine in vaping is on par with nicotine from cigarettes, but the problems from vaping are rarely addressed. I am comfortable that treating vaper addiction is an unmet medical need.
Finally, the last two vouchers were for advancing domestic manufacturing of two products. Ketamine is a critical drug for general anesthesia, on the WHO essential medicines list, and a frequent flyer on the FDA drug shortage list. Augmentin XR is a widely used antibiotic that is often on the drug shortage list.
Sure, there are issues — the program was set up with little information about how vouchers will be awarded, there are questions whether FDA can handle the additional workload accompanying the vouchers, there could be lawsuits based on the shaky statutory basis of the voucher program, and the ever-present risk of favoritism.
The first list of vouchers seems worthy of special FDA attention (via the vouchers).
When the next set of vouchers is announced, I will be looking hard for the not-quite-so-worthy or promising drug from a company in pricing negotiations with the government. Until then, this first list is a good start.