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Pink Sheet – Sequester Travel: Halved FDA Budget Limits Opportunities For Scientists, Impacts Senior Officials Too

Pink Sheet – Sequester Travel: Halved FDA Budget Limits Opportunities For Scientists, Impacts Senior Officials Too

Analysis of meetings in FDA’s public calendar indicates Commissioner Hamburg, other senior leaders continue to attend meetings throughout the U.S. and overseas; stakeholders worry sequester-induced travel cuts prevent rank-and-file scientists from attending helpful events.

FDA Commissioner Margaret Hamburg lamented the toll sequestration has taken on her agency’s travel budget during the keynote speech she gave at the Food and Drug Law Institute’s annual meeting in April.

Reductions to deal with the mandatory budget cuts had prevented the agency from sending some staffers to the conference in Washington, D.C., even though it is a mere subway ride from FDA headquarters. Hamburg said the impact was evident as she scanned the audience. “I have to say the ranks do look a little bit thinner because of the impact of sequestration and I’m sorry,” she told the group.

A review of FDA’s public meetings calendar for senior officials through late August by “The Pink Sheet” suggests that the federal budget restrictions have resulted in senior leader travel being more concentrated among a handful of officials, even squeezing out some who are responsible primarily for international issues. It is perhaps unsurprising that more of the travel budget would be allotted for the top officials who represent the agency. But rank-and-file FDA scientists who are traveling less might be missing out on collaboration and educational opportunities that arise from meeting stakeholders in person.

Agency travel budgets were almost halved as a result of the federal budget sequester. The agency lost $209 million in FY 2013 user fees and treasury funds due to the mandatory cuts that took effect March 1. Federal agencies have had to decide which trade-offs to make in consequence. Instead of furloughing employees, FDA decided to reduce travel and training (“Sequestration Day: FDA Will Manage For Now, But Could Suffer Later If Hiring Deferred” — “The Pink Sheet” DAILY, Mar. 1, 2013).

The agency cut “non-regulatory travel,” which means “discretionary types of activities” like meetings, training, conferences and relocations. It does not include foreign and domestic inspections, law enforcement and “foreign program mission.” Cuts were applied “throughout the agency,” including to senior leadership, FDA said.

The agency spent $19 million on non-regulatory travel in FY 2012, down from the $25 million spent in FY 2011. FDA said in August it does not have final FY 2013 figures for travel spending, but to date it was “well below” spending in FY 2012. Non-regulatory travel spending, even at pre-sequestration levels, is a very small portion of the overall FDA budget (0.5% in FY 2012 and 0.7% in FY 2011, based on enacted amounts).

Despite the cuts, Hamburg and a handful of other senior agency staff continue to attend meetings and conferences outside the Washington, D.C., area and overseas, though at a reduced pace compared to calendar year 2012. That year included the most meeting days for FDA senior staff in the last few years.

The public calendar is a list of 20 senior agency officials and the meetings they conduct and attend each week. It also lists other FDA and non-FDA participants at each meeting with a senior official, as well as its purpose. Calendar listings can include conference presentations and public speeches, as well as topical meetings with industry officials and stakeholders. The calendar includes officials at the center director level and above, but does not indicate whether travel patterns have changed for some officials of keen interest to the biopharma industry, such as Office of Hematology and Oncology Products Director Richard Pazdur, Center for Drug Evaluation and Research Deputy Director for Clinical Science Bob Temple, or Office of New Drugs Director John Jenkins. Travel day totals for other staff were not available.

Hamburg, in particular, seems to have mostly kept up her pace of out-of-state and international meetings, based on the calendar analysis.

Less than a week after the FDLI meeting, Hamburg was in Los Angeles to attend the Milken Institute Global Conference and participate in a panel discussion titled “The Promise of the Bioscience Century.” She appeared with House Majority Leader Eric Cantor, R-Va., Sanofi Chief Medical Officer Paul Chew and others. Then on May 1, Hamburg gave the keynote address at the Global Health Product Development Forum in Seattle. She attended the OME Precision Medicine Summit in San Francisco the next day.

Hamburg spent 27 days at meetings outside of the FDA headquarters area, encompassing parts of Maryland, D.C. and Northern Virginia, through Aug. 23, including 17 after March 1. That is on pace to be about eight less meeting days in 2013 than the 51 days she spent at out-of-state or foreign meetings in 2012 (assuming she will spend as much time traveling after Aug. 23 as she did last year: 16 days). This would be six more days than her 2011 out-of-state travel total and 15 more than 2010.

In addition to attending a number of scientific conferences so far this year, Hamburg’s travels included a master’s tea at Yale University and the Aspen Ideas Festival.

Top Four Frequent Travelers

The vast majority of the out-of-state and international meeting days in 2013 appear concentrated among four FDA officials: Hamburg, Michael Taylor, deputy commissioner for foods and veterinary medicine, Janet Woodcock, director of the Center for Drug Evaluation and Research, and William Slikker, director of the National Center for Toxicological Research.

Together they accounted for 76% of all the out-of-state meetings listed on the calendar in 2013, with Hamburg making up nearly 23%, Taylor nearly 27%, Slikker more than 19% and Woodcock about 7.5%. The next highest percentage was less than 6% (see table at end of story).

In comparison, the previous year the four officials comprised about 47% of such meeting days, and similar percentages in the two prior years.

Agency travel restrictions may have contributed to the consolidation of days between fewer senior staff. A smaller travel budget means fewer people would be able to represent FDA at meetings and the most senior staff likely would get first dibs on attendance. The agency said travel consideration is given based on resources, staff availability and expertise in the given area.

The agency also lost one of its frequent travelers in early 2013, which likely cut into the distribution. Stephen Spielberg, the former deputy commissioner for medical products and tobacco, who left the agency in February, comprised about 10% of the out-of-state and international meeting days in 2012, but none in 2013.

Hamburg, senior leaders and staff “will continue to travel domestically and internationally for meetings and activities that are considered critical” to FDA’s “regulatory and consensus-building mission,” FDA said in a written statement on agency travel.

In some cases, agency officials can travel to present at an event on an in-kind basis, that is, their travel is paid for by a university or other approved entity, but an FDA official said that it is becoming tougher to justify as necessary.

FDA said travel only is allowed if it is considered mission-critical. It also said Hamburg will visit several academic institutions and other organizations to “discuss the role of FDA and the importance of young people getting involved in science.”

Overall, senior officials have spent 93 days at meetings between March 1, when sequester took effect, and Aug. 23.

Noting Who’s Not There

A number of FDA officials have not shied away from noting how sequestration has impacted staff travel.

While accepting the Public Service Award during the American Society of Clinical Oncology’s annual meeting June 27, for example, Pazdur remarked: “Unfortunately, due to travel restraints, only a handful of our staff were able to attend this year’s annual ASCO meeting.” He added, “For those who remain behind working in our offices in Maryland, I want to thank each one of you.”

Similarly, at a June 27 appearance at the Drug Information Association June 27, Jenkins commented: “There are very few FDA staff that were able to travel to this meeting this year, which is very unfortunate because this is an important professional development meeting for a lot of our staff.”

FDA said it does not anticipate a “significant impact” on agency effectiveness because of the restrictions. But others have raised concerns about the effect on federal scientists, who miss educational and networking opportunities when they cannot attend professional and other conferences.

Andrew Rosenberg, director of the Union of Concerned Scientists’ Center for Science and Democracy, said in an interview that senior managers need to attend meetings and be seen, but young scientists especially need to venture out and gain new perspectives.

“The fundamental point is you’re punishing federal scientists, you’re undermining the process of science,” Rosenberg said of the travel restriction. “Meeting people face-to-face or getting out and talking to people isn’t something you throw away.”

The FDLI annual meeting, held in the D.C. area, had 200 fewer agency attendees than the 2012 event, while more industry and private-sector officials came to the 2013 event over 2012, said Erin Jones, the organization’s VP of membership and marketing.

Multiple professional and scientific organizations have felt the effects of the reduction and some are trying to tap into virtual meeting tools and find other means to help FDA staff participate in their events.

Martha Liggett, executive director of the American Society of Hematology, said the group’s annual meeting, which draws 20,000 to 22,000 attendees each year, is a chance to find out what is on the cutting edge of the field.

Liggett compared the difference between attending the meeting and simply reading the papers and other material that comes out of it to hiring someone based only on their resume and references as opposed to combining that information with an in-person interview.

“It’s where you get the science, you get a sense of what’s coming along that isn’t ready for primetime yet,” she said in an interview. “That’s part of the reason why you want to be there because you want to be in on those conversations and not have to wait.”

Conferences Look For Creative Ways To Assist FDA Staff

ASH created a program called Government Concierge to help federal employees attend its December annual meeting in New Orleans. It is holding a block of rooms at various hotels in the city at the federal per diem rate for government employees who may not be able to register until just before the conference date.

Liggett said the block is designed to deal with the long approval process federal employees now must go through to gain approval to attend. As of Aug. 14, 36 people had joined the wait list for a room in the government block.

The number of government employees that have attended in past years is not a lot compared to the overall total (250 in 2010 and 187 in 2012). But, Liggett said, “These 250 people are really critically important from the point of view of the other scientists who are there,” Liggett said. “We’re not talking about dollars and cents for the bottom line of ASH … It’s what happens to hematology if you don’t have the kind of collaboration that you ought to have between the regulators and the individuals who are bringing forward the science.”

ASCO said in a statement there was a “heightened concern from FDA staff” about attending its annual meeting this year. ASCO indicated some chose to attend using the group’s virtual meeting tool, but did not track specific attendance figures.

FDA said it continues to offer in-house training and is using video-conferencing to participate in remote meetings.

Staffers also can miss out on opportunities to obtain continuing education credits necessary to maintain professional licensing. Many times one event can offer enough opportunities to satisfy all CE requirements.

The research and consulting firm Rockport Analytics illustrated the potential impact of obtaining CE credits through non-conference avenues. When the U.S. military cancelled its 2013 Military Health System conference for budgetary reasons, Rockport estimated the cost of making up CE credits elsewhere (funded by the federal government) would total $1.1 million, translating into a net loss of more than $800,000 after factoring in savings from not holding the meeting.

The travel reductions also could have a more subtle impact on other program areas such as application reviews or regulation development. For example, a reviewer might not be fully up-to-date on research relevant to an application, and could seek to hire an outside consultant to provide input or require more data or sponsor meetings. Regulatory affairs personnel could lose opportunities to gain differing perspectives on guidances they are writing.

The non-regulatory travel restrictions also come as the agency is looking to improve its transparency with industry and patients.

A number of mandates in the FDA Safety and Innovation Act require FDA to increase its engagement with patients in the drug review process, beyond participation at advisory committee meetings. Many of the events are being held in the Washington, D.C., area, including FDA headquarters, but limiting the ability for staff to depart the Beltway could affect the range of opinions that they are able to gather.

The agency is looking for the best places for patient involvement in the drug development process as part of an effort to increase their voice (“FDA Hunting For Ways To Expand Patient Role In Drug Development” — “The Pink Sheet” DAILY, Aug. 8, 2013). FDA also is conducting disease-specific meetings to hear more about patients’ risk tolerance and treatment needs (“FDA Asks Narcolepsy Patients How Symptoms Change Over Time” — “The Pink Sheet” DAILY, Jul. 18, 2013).

Overseas Meetings Remain, But Delegations Shrinking

International travel overall appears to be waning in the wake of sequester, even as it may be gaining importance for FDA’s increased attention to globalization.

FDA has made clear that it no longer expects to be able to police the entire supply chain for drugs and other products entering the U.S. The supply chain’s increased complexity and expansion makes it increasingly difficult for the agency to find and inspect all the manufacturers. Thus, engagement with foreign regulators has increased in agency priority as FDA has said it wants to work with other countries to share information so its limited resources can be better targeted at those areas of the global supply chain posing the most risk (“FDA Envisions Many Regulatory Coalitions Dealing With Globalization Issues” — “The Pink Sheet,” Sep. 26, 2011).

Senior FDA officials have participated in 13 meetings overseas so far in 2013, according to public calendar entries. Most of them were split between European and Asian destinations in order to attend international conferences.

That is slower than the 2012 pace for overseas meetings. Multiple FDA staff went to China at various times that year, including Hamburg, Taylor and Slikker. The agency also sent representatives to meetings in Argentina, Brazil, Chile, Austria and India.

It appears agency delegations to those meetings are shrinking. Justina Molzon, CDER associate center director for international programs, said at the DIA annual meeting that international travel is becoming “extremely difficult” to justify. “We had to cut our [International Conference on Harmonization] delegation to the bare minimum,” she said.

Agency officials have spent 46 days overseas at meetings so far in 2013, much fewer than the 108 days spent overseas in 2012.

Mary Lou Valdez, associate commissioner for international programs, has listed only one out-of-state meeting in 2013 as of Aug. 23: a three-day meeting in April in Geneva, Switzerland, for a World Health Organization counterfeit medical products steering committee event. She listed or participated in 30 days of meetings in 2012, a number of them outside the country.

Deborah Autor, former deputy commissioner for global regulatory operations and policy, only reported two out-of-state meetings in 2013, in Cambridge, Mass. and Austin, Texas. She spent seven days at meetings in 2012, including events in Brazil and India. Autor, who left the agency June 1 to join Mylan Inc., took the deputy commissioner position at FDA as part of a 2011 agency reorganization that created directorates intended to better align personnel with agency priorities (“FDA Reorganization Adds “Directorate” Layer, But Sharpens Agency’s Focus” — “The Pink Sheet,”Jul. 18, 2011).

Slikker has been among the most frequent overseas travelers at FDA, attending meetings in Japan and South Korea for a total of seven days in 2013. In 2012, Slikker spent nine days in various cities in China, as well as four days in Quebec City, Canada, and two days in Salzburg, Austria, at meetings, for a total of 15 meeting days.

In late January, Hamburg spent seven days at two meetings in Europe, including five days at the World Economic Forum annual meeting in Davos, Switzerland. She spoke at a panel about irresponsible use of antibiotics and how international regulations should be strengthened and new investment is required. She also sat on a panel titled “The Future of Health,” where she and four others talked about generating policies fostering innovation and research.

Hamburg attended an International Coalition of Medicines Regulatory Authorities meeting on May 16 -17 in Rome. and then the annual meeting of the World Health Assembly, the decision-making body of the World Health Organization, May 19 in Geneva, where she co-hosted a special session on pharmacovigilance. She wanted to outline “a vision for the future” for “a global safety net, where consumers, industry, governments and international organizations work together to ensure safe and high-quality products,” according to an FDA blog post.

Woodcock also travelled to Stockholm, Sweden, for two days of meetings in June on breakthroughs in genomic and personalized medicine.