The Association of Accessible Medicines (AAM) continued Day 1 with a discussion of what’s happening on Capitol Hill and how we can be working to position industry priorities with policymakers to make the most positive impact on patient access. The session was conducted as a fireside chat hosted by Mark Ratner, Senior Vice President, Government Affairs, of AAM, with Cristina Antelo, Esq., Founding Principal and Chief Executive Officer of Ferox Strategies, and Kate Hull, Senior Vice President, Fierce Government Relations.

When Mark asked them what one word describes the sentiment on the Hill, both agreed that the word “unpredictable” pretty much summed it up. They noted that the buzzwords for any chance of action on legislation have to be “affordability” (lowering patient costs) and “accessibility.” They also noted that supply-chain resiliency is important, but it’s not going to be solved overnight. There was a big hooray for the Q1-Q2 legislation that passed, attached to a non-health-related piece of legislation, but neither of the panelists thought that we would see much action on other health-related agenda items until the end of the year unless something big came along that could get tacked onto a must-pass piece of legislation. They noted that the administration wants to see the creation of jobs, but the latest massive layoffs in the industry have not helped. This is another reason that the administration is looking to onshore the manufacture of finished products and active pharmaceutical ingredients but, while there is movement afoot, there is going to be a delay in achieving a significant number of new jobs for possibly two to three years as facilities break ground, are built, and qualified.

The star of the show was former FDA commissioner Scott Gottlieb, M.D. who had his own fireside chat hosted by John Murphy III, President and CEO of AAM. Some highlights from Dr. Gottlieb’s responses are provided below:

  • He noted that China is rapidly overtaking the Car-T and complex biologics market, and beginning to partner with U.S. companies and license molecules to U.S. subsidiaries.
  • China can do clinical studies much cheaper and faster than in the U.S., giving them a significant advantage.
  • Putting legal and intellectual-property controls on China may not be the right approach as we need to promote the U.S. internally.
  • America first at all costs might not be the best approach.
  • In talking about most-favored-nation pricing, Dr. Gottlieb noted that if U.S. prices for innovator products are forced down, European prices will go up. This could place pressure on U.S. companies to delay launches, which may be an opening for China to enter the EU market.
  • Part of “America First” is concern about national security issues. While this might be somewhat true with China, what about Ireland, which poses no threat to U.S. national security? There needs to be a balance in our approach that recognizes the level of threat.
  • On imposing tariffs, he noted that once the tariff issue appeared to be settled, investment in dealmaking increased. As soon as uncertainty in the U.S. tariff position resurfaces, the threat of tariffs rising causes venture capitalists to worry and investing to decrease or pause.
  • The most important issue is that an immediate move to onshore U.S. production should be directed at a single point of failure. That is, if there is only one facility in the country or the world that supplies a specific product or ingredient for a lifesaving product, these should be the focus for redundancy and addressed first, by building redundant facilities or stockpiling critical components and starting materials.
  • It’s much harder for generic companies to bring manufacturing back to the U.S. than it is for brand companies due to the very low margins for generic products, and there should be some other incentives to overcome this issue.
  • One of the issues that Dr. Gottlieb addressed was the need to rebuild the FDA infrastructure to counter the loss of 4,000 full-time employees cut by DOGE. The firing and attrition attributed to these cuts caused a significant loss of institutional knowledge and saw other highly qualified senior and middle-level reviewers and managers leave the Agency. Gottlieb noted that he felt that it would be a generational effort to rebuild the Agency.
  • He believes that the review metrics are likely to be impacted for years to come.
  • When John Murphy asked Dr. Gottlieb what one big change he would make right away if he came back to the FDA, Dr. Gottlieb first responded, “I am not coming back to the Agency so let’s get that straight right now! However, the first thing I would do is find a way to immediately begin to strengthen the FDA by bringing in senior staff and junior managers to begin the rebuild.”

Hopefully I didn’t misconstrue any of Dr. Gottlieb’s comments. It’s clear that this summary does not cover the full hour that he recounted his views. Dr. Gottlieb was an amazing FDA commissioner who got a lot done and is in a unique position, with his experience and background, to not only tell it like it is but also accurately diagnose the problem and offer his trusted view of a path forward.