US FDA May Largely Avoid House Democrats' Investigation Agenda
Executive Summary
Drug pricing hearings likely will involve FDA, but most pressing issue facing agency following midterms may be whether Commissioner Gottlieb will depart.
The US FDA's lawyers likely will not be expecting a flurry of subpoenas once the new Democratic majority takes power in the House of Representatives.
Hearings focused on drug pricing are a certainty and will almost surely include FDA Commissioner Scott Gottlieb, given his involvement in the administration's blueprint to reduce prescription costs. But several experts the Pink Sheet consulted struggled to pinpoint other issues involving the agency that would warrant similar investigative scrutiny.
Indeed, the most pressing concern for FDA and stakeholders may be whether Gottlieb will remain FDA's leader for the duration of President Trump's term.
Nancy Myers, president and founder of Catalyst Healthcare Consulting, said the House will have limited bandwidth for oversight and there appear to be other Trump appointees that would be a priority.
However, FDA likely will remain on the House radar. Myers said if Gottlieb is called to Capitol Hill to discuss ongoing efforts at the agency, a topic could be "to see if and how the rank-and-file is following his announcement-driven agenda."
Peter Barton Hutt, senior counsel at Covington and Burling, agreed that FDA still should expect close oversight.
"Scott Gottlieb is doing so well that the House Democrats are likely to pick easier targets," he said. "But FDA could see an increase in House hearings."
Gottlieb has largely earned high marks from stakeholders across the political spectrum, as well as his bosses at HHS and the White House. (Also see "US FDA Commissioner A 'Star' At Davos: Hopefully Not A Bad Omen" - Pink Sheet, 29 Jan, 2018.)
Opioids, Combination Product Questions May Loom
Speeding generic drug and combination product approvals may be among the issues that spark the new majority's interest, Myers said. Both are connected to drug pricing efforts, but also could come up in general oversight efforts by the House.
Gottlieb has touted the record-number of approvals the Office of Generic Drugs issued in FY 2018, but could face questions about how the agency intends to increase the number of first-cycle approvals. (Also see "US FDA Sets Generic Approval Record, But Generic Sponsors Aren't Celebrating" - Pink Sheet, 12 Oct, 2018.) The agency also did not approve any ANDAs using the priority assessment pathway Congress established in the 2017 FDA Reauthorization Act, which may be a concern. (Also see "Lack Of Priority? No ANDAs Approved Using Expedited Pathway In FY 2018" - Pink Sheet, 5 Nov, 2018.)
In addition, FDA has been working to streamline and clarify the combination product approval process, which has historically been slow-moving. (Also see "US FDA Preparing For New 'Combination Product Agreement Meetings'" - Pink Sheet, 22 Oct, 2018.)
Opioids policy also may warrant scrutiny.
Recent opioid approvals have invited criticism from several stakeholders as the administration is trying to reduce opioid addiction. Gottlieb issued a statement justifying the approval of AcelRx Pharmaceuticals Inc.'s Dsuvia (sufentanil sublingual) amid calls for the application to be denied. (Also see "Dsuvia Approval May Be Followed By New Opioid Review Paradigm At FDA" - Pink Sheet, 2 Nov, 2018.)
Dsuvia may prompt the House to revisit the issue again even though Congress recently passed opioid legislation, which was enacted in late October. (Also see "Opioid Policy At US FDA: Over-Promising Or Overreacting? " - Pink Sheet, 24 Oct, 2018.)
FDA is extending beyond its traditional purview as part of efforts to stem the opioid epidemic, working with the National Academies of Sciences, Engineering and Medicine to develop opioid prescribing guidelines. A public meeting on the subject is scheduled for Nov. 13.
Gottlieb wants prescribing guidelines incorporated in labeling and used to mandate packaging standards. (Also see "Opioid Blister-Pack Mandate Tops Gottlieb's Agenda With New Authority" - Pink Sheet, 21 Oct, 2018.)
Waiting For Gottlieb's Departure
Stakeholders likely will be watching Gottlieb for signals that he will leave FDA for another post within the administration or return to the private sector.
Gottlieb has given no such indication. However, senior staff often exit the administration after mid-term elections and rumors are beginning to swirl about the end of his tenure.
Gottlieb has served about 18 months as FDA commissioner. Several of his predecessors have served about two years or less. The exceptions were David Kessler and Margaret Hamburg, who served about six years. Mark McClellan, whom Gottlieb worked under during a previous stint at FDA, held the position less than 17 months. (See chart below.)
McClellan's relatively shortly tenure is in many ways unusual though. Over the past few decades, FDA commissioners have in fact tended to serve for a number of years unless forced out by a change of administration, with two exceptions: Lester Crawford's blink-and-you-missed-it time as the head of the agency ended because of an ethics scandal involving stock holdings, and McClellan left to become the administrator of the Centers for Medicare and Medicaid Services.
Gottlieb has broken a lot of ground as commissioner; simply leaving the administration at this point would also make his tenure stand out.
Michael Cipriano contributed to this story.