WASHINGTON – U.S. Reps. Joe Barton, R-Texas, ranking member of the House Energy and Commerce Committee, and Michael Burgess, R-Texas, ranking member of the Oversight and Investigations Subcommittee, today asked Food and Drug Administration Commissioner Margaret Hamburg about the agency’s new policy banning employees from owning family farms.

A Nov. 17 article in The Gazette (Bethesda/Potomac/Chevy Chase) discusses a memo sent to FDA employees instructing them to sell their farming interests within 60 days in order to comply with conflict-of-interest rules.

“We are concerned that the actions demanded by the September 29 memorandum may be unreasonable, if not draconian, both in substance and in form. We are not aware of any actual case or problem justifying the reinterpretation,” Barton and Burgess wrote. “Thus, it is a mystery to us how these FDA employees who own family farms, many of whom have reported their farming to the agency through financial disclosures for 14 years, now suddenly stand to potentially harm ‘public confidence in the impartiality or objectivity with which FDA programs are administered’ or to otherwise raise serious conflict of interest concerns under the standards of ethical conduct for employees of the executive branch  (61 FR 39758).’

“Without FDA being transparent about the evidentiary need for this reinterpretation, this has the appearance of a solution in search of a problem,” they added.

Barton and Burgess asked Hamburg to respond to the following questions:

1.    How did the reinterpretation of FDA’s employee conflict of interest rules, as reflected in the September 29 memorandum, come about? In your answer, please discuss how FDA’s legal interpretations on what constitutes an FDA-regulated product have evolved over the 14-year period between the publication of these supplemental standards and the drafting of the September 29, 2010, memorandum.

2.    What was the basis for FDA to reject measures such as recusal that are short of divestiture to address any ethics concerns?

3.    What was the reasoning behind the September 29 memorandum’s demand that the FDA employee’s farm ownership interests be sold within 60 days? On what basis was the 60-day figure chosen, and not, for example, 12 months or 2 years?

4.    How many FDA employees stand to be affected by the memorandum’s demand that they divest from their farm ownership interests within 60 days? Shouldn’t FDA have known how many of its employees could be potentially affected by a ban on farming prior to the distribution of the September 29 memorandum?

5.    Has FDA given any consideration to the financial or other harms that may be incurred by employees unable to carry out the demands of the September 29 memorandum within the 60-day period? Between September 29, 2010 and the present time, have any FDA employees already experienced financial losses due to a rush to sell or lease their land pursuant to the September 29 memorandum’s instructions?

6.    Until what date will the enforcement of the reinterpretation of FDA’s conflict of interest rules governing FDA employees be held in abeyance? What procedures are in place to review and/or renew this enforcement suspension prior to arrival of that date?

7.    What steps has FDA taken to ensure that employees affected by the reinterpretation, and any future modifications, will be notified thereof in full, and within a reasonable period of time?

A copy of the letter can be found here.