FDA Scientists Give Leadership High Marks; Some Worry About Industry Influence

Union of Concerned Scientists' survey finds 65% of 354 respondents feel their direct supervisors back them on politically contentious positions; Commissioner Gottlieb gets glowing reviews.

FDA stands out from other federal agencies, as staff scientists report high rates of job satisfaction, office effectiveness, and support from their supervisors in a survey conducted by the Union of Concerned Scientists (UCS).

The organization surveyed scientists at 16 federal agencies in February and March to get a sense of their work environment and the state of scientific integrity in these agencies. UCS sent surveys to 9,378 scientists and scientific experts at FDA and received 354 responses, a 3.8% response rate. Of these, 83% were at general schedule payscale 12 (GS-12) and above, 3% were GS-11 or lower, 4% were commissioned corps, 2% were fellows, and 4% were contractors.

The report, Science Under Trump: Voices of Scientists Across 16 Federal Agencies, says there are significant disparities regarding how different departments and agencies treat science and scientists, with some agencies moving aggressively to limit the use of science and others recognizing its utility.

"Scientists at the FDA reported that they were faring better than their colleagues at most of the 16 federal agencies surveyed. Also in contrast to other agencies, scientists generally expressed faith in FDA leadership, including the FDA commissioner," the report's fact sheet on FDA states.

 

"The current commissioner is fantastic and committed to the FDA's mission," an FDA scientist said in response to a survey question.

 

Praise For Gottlieb

The report said most scientists reported no change in personal job satisfaction or perception of office effectiveness in 2018, and some noted increased job satisfaction during the past year. Twenty-five percent (87 respondents) said that the effectiveness of their division or office has increased compared with one year ago and 48% (170 respondents) reported no change.

Genna Reed, science and policy analyst at UCS's Center for Science and Democracy, reviewed responses to open-ended questions in the survey, in which scientists praised FDA Commissioner Scott Gottlieb. In an Aug. 15 blog post titled "Strong Leadership Makes for Satisfied Federal Scientists: A Case Study at the FDA,"  she said their sentiment is reflected in a comment from one respondent who said: "The current administration has overall enforced certain science policies which harm the public in general. However, the current commissioner is fantastic and committed to the FDA's mission. He is consistently involved in policy development which allows the protection and promotion of public health."

Another respondent said, "the commissioner's office is tirelessly upholding best practices in various scientific fields such as smoking cessation, opioid/addiction crisis, generic drug manufacturing, sustainable farming practices."

And yet another wrote that "FDA has a proactive commissioner who – so far – has consistently followed science-based information and promoted science-based initiatives in the interest of public health."

FDA also scored well compared to other agencies in the annual federal government Best Places to Work rankings, which is produced by the non-profit Partnership for Public Service based on Office of Personnel Management survey data. In its 2017 rankings, FDA was 32^nd out of 150 federal agency components. (Also see "FDA's Hiring Advantage: Scores In Best Places To Work Survey Continue To Rise" - Pink Sheet, 7 Feb, 2018.)

Freedom To Disagree

UCS has conducted several agency surveys since 2005.  Surveys in 2006 and 2012 just queried FDA scientists, while a 2015 survey queried FDA and three other agencies. In the 2006 survey, 5,918 scientists were surveyed and 997 responded. In the 2012 survey, 7,043 scientists were surveyed and 997 responded. A 2010 survey focused on food safety scientists included some FDA staff. The 2018 is the largest in seeking input from scientists at 16 agencies.

A few questions appeared in all these surveys, including a query on whether a direct supervisor stands behind scientists who put forth scientifically defensible positions that may be politically controversial or contentious. The percentage of scientists who "strongly agree" shot up to 35% in 2018, compared to 8% in 2006, 27% in 2012 and 18% in 2015 (see chart below).

 

 

Another question asked whether scientists felt they could openly express concerns about the agency's work without fear of retaliation and responses remained relatively constant over time. In the 2006 survey, 47% felt they could openly express concerns and 36% felt they could not.  

In the 2012 survey, 53% felt they could openly express concerns without fear of retaliation and 26% said they could not, while in the 2015 survey 54% agreed they could openly express concerns, 24% felt they could not and 23% said they did not know. In the 2018 survey, 52% felt they could express concerns, 22% felt they could not, 23% did not agree or disagree on whether they could do so, and 2% preferred not to disclose their views.

FDA has encouraged reviewers and others to voice disagreements during reviews. In one of the most public internal disputes, reviewers opposed approval of Sarepta Therapeutics Inc.'s Duchenne muscular dystrophy treatment Exondys 51 (eteplirsen). Center for Drug Evaluation And Research Director Janet Woodcock overruled them and granted accelerated approval. The decision was appealed internally to then-Commissioner Robert Califf, who sided with Woodcock. (Also see "Woodcock's 'Bias' In Sarepta Case Made Jenkins Worry About Future Drug Reviews" - Pink Sheet, 31 Jul, 2017.)

Another question asked scientists if they were provided adequate time and resources to keep up with advances in their profession, such as attending conferences and training, and participating in scientific or professional societies. The percentage who answered "strongly agree" or "agree" was 50% in the 2018 survey compared to 47% in 2015, 58% in 2012 and 36% in 2006 (see chart below). The high marks in the latter years are interesting given the concern in 2013 and 2014 that scientific travel was being limited due to federal budget sequestration.

 

 

Outside Influence

In the latter surveys, UCS queried scientists about outside influences on FDA's decisions. In the 2012 survey, 24.6% said business interests have a lot of weight in final decisions and 37.8% said they have some weight. And 30.6% said political interests have a lot of weight and 32.8% said they have some weight on FDA's final decisions.  

In the 2018 survey, about one-third of respondents cited the consideration of political interests and influence of business interests as a barrier to science-based decision-making.

The report cites one scientist who said: "My greatest criticism of FDA has to do with how safety data are interpreted. Nobody is fudging the data, but the strong emphasis on approving drugs leads to pressure to downplay safety information."

Some FDA scientists also questioned the influence of agency leaders who come from industry. The report said 22% (70 respondents) felt that the presence of senior decision makers from regulated industries or with financial interest in regulatory outcomes inappropriately influences FDA decision-making.

About a quarter of respondents had industry ties. In response to a question if they ever worked for regulated industry or a group representing them, 26% said yes, 72% said no and 2% preferred not to disclose the answer.

Several years ago, FDA sought industry candidates to fill leadership positions. It hired several individuals, including former Sanofi exec Gregory Geba, who took the post of Office of Generic Drugs director in 2012 but left after eight months. Stephen Spielberg, who previously worked at Merck & Co. Inc. and Johnson & Johnson, was hired in 2011 as deputy commissioner for medical products and tobacco and left less than two years later for personal reasons. Former Genzyme Corp. executive Richard Moscicki became Center for Drug Evaluation and Research deputy center director for science operations in 2013 and left in 2017 to join the Pharmaceutical Research and Manufacturers of America. Moscicki was replaced in January by Patrizia Cavazzoni, who came from Pfizer Inc. (Also see "US FDA Taps Pfizer Executive For CDER Deputy Director Slot" - Pink Sheet, 1 Feb, 2018.)

And in 2016, Peter Stein joined the agency from Merck Research Laboratories to become deputy director of CDER's Office of New Drugs. (Also see "Merck R&D Exec Jumps To US FDA As Office Of New Drugs Deputy Director" - Pink Sheet, 8 Nov, 2016.)

Gottlieb recently said that filling vacant division director or office director positions with someone outside the agency would likely be the exception. He said a more likely scenario would be to bring someone from outside into a more senior medical review position where they have a more accelerated trajectory into leadership positions. (Also see "US FDA Hiring For Senior Staff Vacancies Boosted By Cures Act, Pilot Program – Gottlieb" - Pink Sheet, 7 May, 2018.)

Workforce Reductions

The survey also queried scientists about the impact of workforce reductions. Forty-nine percent (174 respondents) reported observing workforce reductions during the last year due to staff departures, retirements, or hiring freezes and of these, 80% (139 respondents) reported that such reductions make it difficult for FDA to fulfill its science-based mission. In addition, 25% (90 respondents) cited limited staff capacity as one of the greatest barriers to making science-based decisions.

UCS offered recommendations for FDA. "With respondents noting some interference from business interests, the FDA could best improve scientific integrity if agency leaders reaffirm that the agency's scientists have the freedom to pursue and communicate openly about their scientific work without asking for permission, regardless of whether the work is politically contentious," UCS stated. "Moreover, agency leadership should ensure scientists have adequate time and resources to pursue professional development opportunities and encourage them to do so."