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March 11, 2019

Gottlieb's got some unfinished business. What happens to it when he leaves?

Daily Briefing

    By Ashley Fuoco Antonelli, Contributing Editor

    Washington, D.C., often is viewed as a town of political partisanship and gridlock, and it's rare for a policymaker to break free from those preconceptions. But FDA Commissioner Scott Gottlieb did that just—transforming from a nominee who once raised widespread skepticism to an effective official with widespread support from industry stakeholders, fellow policymakers, and political observers alike.

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    So Gottlieb's announcement last week that he will resign from his position sent waves through Capitol Hill and the health care industry—and sparked questions about the future of some important initiatives he put in motion. Let's take a closer look.

    Gottlieb started some significant reforms—but what will happen to them now?

    Gottlieb's time as FDA commissioner was most notably spent overhauling the agency's drug approval processes, stemming e-cigarette use among U.S. teenagers, and combating the opioid misuse epidemic. While many of the efforts Gottlieb championed already have taken effect, others remain in limbo—and it's unclear whether they will come to fruition without Gottlieb's leadership.

    Here are the three biggest ongoing initiatives that could putter out:

    1. Cracking down on menthol and electronic cigarette flavors:

    Gottlieb has called youth vaping an "epidemic" that could cause yet another generation of teens to become addicted to nicotine, and last year, he unveiled a five-step plan to lower e-cigarette use among children and teens. Gottlieb took steps to implement several of those initiatives, such as launching a nearly $60 million education campaign and investigating the marketing tactics behind more than 40 e-cigarette products. Further, in November 2018, FDA unveiled a long-rumored proposal to limit the sale of most flavored e-cigarettes and ban the sale of methanol-flavored cigarettes and cigars in the United States.

    While many health care groups praised the proposal, some observers criticized the move. The critics said limiting sales of flavored e-cigarettes would negatively affect adults who use e-cigarettes to quit smoking, and cigarette manufactures threatened legal action against Gottlieb's proposal to ban menthol cigarette sales. Some lawmakers, including Sen. Richard Burr (R-N.C), also have pushed back against the proposals.

    The White House Office of Management and Budget currently is reviewing the proposal—but it seems as if some think it could be derailed by Gottlieb's departure. Vox's Julia Belluz notes that tobacco stocks rose Tuesday after news of Gottlieb's resignation broke, and Amy Fairchild, a tobacco control expert at Texas A&M University, told Belluz, "[The] resignation throws into question how the FDA will continue to chart a path forward on smoking harm reduction."

    Matthew Myers, president of the Campaign for Tobacco-Free Kids, told USA Today's Ken Alltucker and Jayne O'Donnell, "[Gottlieb] initiated a number of potential actions that would have made an extraordinary impact, but he leaves with those actions unfinished." Myers added, "On e-cigarettes, he deserves credit for shining a spotlight on the crisis of youth e-cigarette use. It will be impossible to reverse that crisis unless the FDA adopts industry-wide rules before he leaves."

    But Gottlieb sought to allay those concerns, saying he's "very confident" FDA will "advance" his proposal to limit the sale of most flavored e-cigarettes and ban the sale of methanol-flavored cigarettes and cigars "over the next month." Gottlieb also said he doesn't expect momentum on addressing rising e-cigarette use among youth to decline. "I think you're going to have a groundswell of people who are going to demand action," he said, adding, "We're going to continue to advance policy. I'm very confident of that."

    2. Fighting the opioid epidemic:

    Under Gottlieb, FDA in 2017 took the unprecedented step of getting the opioid medication Opana ER pulled from the market because of concerns the drug's addictiveness outweighed its benefits. FDA also approved US WorldMeds' Lucemyra, the first non-opioid treatment for managing opioid withdrawal. Further, the agency in January took what Gottlieb called an "unprecedented" step by creating its own Drug Facts label for the opioid overdose treatment naloxone, which manufacturers potentially could adopt in the process of making the drug available over-the-counter.

    But Gottlieb didn't stop there: Last week, Gottlieb said FDA would consider a new framework that would allow the agency to evaluate each new opioid drug in the context of how the drug might fit into the therapeutic options already available to patients and providers and help the agency determine "whether the new opioid should offer some comparative benefit over existing drugs," Inside Health Policy's Beth Wang writes. According to Wang, Gottlieb also said FDA would "pursue new efforts to evaluate the effectiveness of the Risk Evaluation and Mitigation Strategy program for opioid products, and work with U.S. Customs and Border Protection to expand information sharing and maximize each agency's inspection and detection capabilities at the border"—but it's unclear where those plans stand.

    3. Modernizing FDA's drug approval and evaluation processes:

    Gottlieb spent his first year as FDA commissioner implementing proposals to accelerate generic drug approvals and modernizing the review process for new gene and cell therapies. In January, he announced plans that went one step further: FDA would establish a new office, the Office of Drug Evaluation Science, to develop a more structured approach to data analysis for drug approvals. This Gottlieb said was part of a broader effort to restructure FDA's drug approval processes. But FDA has not yet launched the office, and it's not clear where work on doing so stands.

    Further, in January of this year, Gottlieb and Peter Marks, director of FDA's Center for Biologics Evaluation and Research, announced new plans to ensure FDA would be able to keep pace with an expected influx of gene and cell therapies. However, FDA has not yet released those documents.

    Despite the lingering uncertainty, Politico reports that Gottlieb's changes regarding accelerating and modernizing drug approvals "are likely to endure." Senate Finance Chairman Chuck Grassley (R-Iowa) on Wednesday said he's ready to help further Gottlieb's legacy through legislative initiatives, adding, "We've got to refine the process in FDA for all drugs, in particular for generics."

    What to watch

    Grassley noted that whether the initiatives Gottlieb started are carried out will depend on the commissioner's successor. As of now, Amy Abernethy, FDA's principal's deputy commissioner, would take over as acting FDA commissioner upon Gottlieb's departure. However, the Wall Street Journal's Thomas Burton and Jennifer Maloney report that a short list for Gottlieb's permanent replacement already is taking shape, and includes Norman Sharpless, director of the National Cancer Institute, and Brett Giroir, HHS' assistant secretary for health.

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