A new FDA Commissioner’s agenda


Jon Bigelow

Consider the sweeping scope of the Food and Drug Administration: It regulates the pharmaceuticals and devices that power medical innovation as well as the nation’s food supply, and directly touches 20 percent of the U.S. economy. The FDA Commissioner sets the tone and priorities for this far-reaching work. Now that President Trump has nominated Dr. Stephen Hahn to be the new Commissioner, what obstacles remain to his Senate confirmation, and what will top his agenda?

The path to confirmation

So far, the process has moved expeditiously. President Trump officially nominated Dr. Hahn on November 1, and the Senate Health, Education, Labor, and Pensions (HELP) Committee held his confirmation hearing just three weeks later, on November 20.

At first blush, Dr. Hahn does not appear to be a controversial choice. He has a strong reputation as a radiation oncologist and researcher and can point to leadership experience at large institutions (currently as Chief Medical Executive at MD Anderson Cancer Center). Unlike most former Commissioners, Dr. Hahn’s resume is notably lacking in government experience, and he has almost no written or spoken record on FDA issues or healthcare policy.

The two month delay between Dr. Hahn’s interview with President Trump and the formal nomination should have allowed time for vetting any conflicts of interest or off-the-wall opinions that might derail a confirmation vote. Yet even after 135 minutes of questioning at the HELP Committee hearing, we know very little about Dr. Hahn’s opinions on the issues he will face as FDA Commissioner. He deftly dodged offering specific opinions and said nothing controversial.

Chair Sen. Lamar Alexander (R-Tenn.) indicated the committee will consider Dr. Hahn’s nomination on December 3 and expects a vote in the full Senate before year end.

What could go wrong?

The nomination appears to be on a glide path, but turbulence is still possible.
• Senators on the HELP Committee did not grill Dr. Hahn on conflicts of interest or his record at MD Anderson. Issues may be raised at any time before the vote.
• Senators from both parties used the hearing to rail against the Trump administration’s reluctance to ban flavored vaping products. Sen. Mitt Romney (R-Utah) described vaping as “the canary in the coal mine” – a reflection of how Dr. Hahn would handle other difficult issues. A succession of Senators probed for details on Dr. Hahn’s plans without eliciting much more than a general promise to take “bold action.” The final questioner, Sen. Doug Jones (D-Ala.), made clear he was “less than happy with your answers” and suspected the nominee had been “prepped by your handlers” to “bob and weave” on this issue. Given this bipartisan frustration, confirmation could be delayed as leverage to get President Trump to enact a ban on flavored vaping products.
• The planned schedule – a vote before the end of December – would land this confirmation on the Senate calendar at a perilous moment: It would compete for attention with budget battles (the latest Continuing Resolution set December 20 as the next deadline) and the impeachment process (with a trial in January).

A real danger is that the timetable slides. Already 8 months have passed since Dr. Scott Gottlieb resigned as Commissioner. The Acting Commissioner, Dr. Ned Sharpless, has been replaced by Dr. Brett Giroir, the Assistant Secretary of Health and Human Services, the third head in quick succession. This year the FDA has lost some key personnel, and the interregnum has not helped the perennial difficulty in filling the many open positions at the agency. We need only look back to the George W. Bush administration, when there was a succession of short tenures by acting and permanent Commissioners, to see how the agency can drift without strong leadership; this was a period of fewer drug approvals, declining budgets, failure to improve infrastructure, and other missed opportunities.

Once confirmed, what next?

On Day One, Dr. Gottlieb – an FDA veteran –already knew the processes, traditions, and many of the key leaders of the agency, and had strong ties on Capitol Hill. On his own Day One, Dr. Hahn has to first learn the ropes and build personal relationships.

Even if Dr. Hahn is confirmed fairly promptly – say, before the end of January – he will enter office knowing that his tenure may not last more than the one year remaining in President Trump’s first term. He may have time to accomplish only a handful of things, so he will need to prioritize.

We know very little about what issues Dr. Hahn sees as most important. Will he focus on efficiencies in clinical research, or the opioid epidemic, or gene therapies, or cannabidiol products, or barriers to biosimilars? And will he be the superb communicator that Dr. Gottlieb was?

Of course, his agenda will also be determined by the political processes around him, among them:
• Dr. Hahn will be pressed to follow through on his promise of “bold action” against vaping, and may find himself in an awkward place if the Trump administration decides not to ban flavored products.
• Both parties want to show progress in lowering drug prices, and some proposals touch on the FDA’s areas of authority. For example, President Trump, Senate Republicans, Speaker Pelosi, and many Democratic presidential candidates advocate importation of drugs from other countries; yet past FDA Commissioners have long opposed this due to concerns about manufacturing quality overseas and the inability to track imported drugs through the entire supply chain. What will be Dr. Hahn’s position, and are there other ways in which he believes the FDA can make pharmaceuticals more affordable?

One of Dr. Gottlieb’s and Dr. Sharpless’ greatest contributions over the past three years has been to keep the FDA focused on science and largely shielded from a political agenda, in contrast to what has been seen at some other federal agencies. During his confirmation hearing, Dr. Hahn stated that he is “a scientist and a medical doctor” and promised he will follow science, data, and the law; I sincerely hope that he will do so. Watch along with us at www.cohealthcom.org. medadnews