Legislative Amendment Could Affect FDA's Ability to Meet with Industry

Posted 19 March 2013 | By Alexander Gaffney, RAC 

Even if it had the funding to do so, the US Food and Drug Administration (FDA) may soon find itself unable to send too many of its employees to some meetings if an amendment to a pending budget bill takes hold.

The House and Senate are both now working on what is known as a continuing resolution (CR)-a budget bill that would by and large keep government funding as it now is for the remainder of the fiscal year. The hope is that after that bill runs out, Congress will have passed into law a new budget that will take its place.

The process remains ongoing, but a proposed amendment (Amendment 67) to the Senate version of the CR introduced by Sen. Tom Coburn (R-OK) would prevent any agency from sending more than 25 employees to a single conference without justification.

"This amendment extends the prohibition in the CR to cover all federal agencies and all conferences, both within and outside of the United States," it reads. "It also lowers the number of employees to 25. Therefore, the amendment would prohibit funding for more than 25 federal employees to attend any conference, including one in the United States."

Are Meetings Good for Regulatory Professionals?

At issue is the amount of money federal agencies spend on their own conferences, as well as the amount of money spent sending employees to conferences (travel, time off, etc).

While Coburn's amendment would allow agencies to provide justification for the meeting so long as it is provided five days prior to its start, many associations have cried foul, arguing it creates barriers between regulators and the regulatory affairs professionals and companies they regulate.

"While associations understand the need for fiscal responsibility when it comes to spending taxpayer dollars, the Coburn amendment would severely diminish federal agencies' participation in face-to-face meetings with the industries they regulate," wrote the Center for Association leadership (ASAE)-an association for associations-in a statement on 15 March 2013.

"[The] Coburn amendment … restricts the important dialogue that occurs at meetings and conferences attended by government employees and the private sector," they added. "Amendment 67 would arbitrarily limit the number of federal employees who can attend a meeting or conference to learn about the latest industry practices and pick up insights from the private sector that could lead to more effective policymaking."

Background and Impact

The measure is similar in principle to others introduced during the 112th Congress after a scandal involving the General Services Administration (GSA), which held a conference involving a mind-reader, clown, high-priced hotel accommodations and thousands of dollars in sushi, in addition to other excesses. In the wake of that event, legislators sought to crack down on government meeting and conference spending.

It is unclear how many, if any, conferences conducted by FDA would be affected by the legislative language if it is signed into law. FDA has already indicated that it will severely curtail travel and meeting spending to deal with the effects of sequestration, up to and including turning its advisory committee meetings into teleconference meetings.

Full Disclosure: RAPS, the parent organization of Regulatory Focus, is an association that puts on conferences and other meetings that attract FDA attendance.

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