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We don’t normally follow Freedom of Information Act (“FOIA”) decisions, but Public Citizen v. U.S. Dep’t of Health and Human Services, ___ F. Supp.2d ___, 2014 WL 4388062 (D.D.C. Sept. 5, 2014), falls more or less in our sweet spot.  Back in 2009, Public Citizen, an ostensible “public interest” group that regularly acts as a stalking horse for the plaintiffs’ bar, filed a FOIA request demanding disclosure of a drug manufacturer’s annual reports filed with defendant HHS pursuant to a “corporate integrity agreement.”  Such agreements are often part of settlements of claims brought by the government alleging illegal activity.  The claim in Public Citizen involved off-label promotion.

A number of issues were resolved in an earlier opinion, Public Citizen v. U.S. Dep’t of Health & Human Services, 975 F. Supp.2d 81, 88–89 (D.D.C. 2013).  The most important remaining issues involved disclosure of:

  • Reportable event summaries
  • Disclosure log summaries, and
  • Records reflecting the content of detailing sessions between healthcare providers and manufacturer’s representatives disclosed to the government.

2014 WL 4388062, at *4.

The good news is that the intervening manufacturer won all of these issues – no FOIA disclosure of these materials was required.

The court ruled that these materials were:  (1) commercial in nature, even though involving possible regulatory violations, (2) legitimately confidential as capable of informing a competitor of how the defendant markets its products, i.e., what it considers “lawful” promotion; and (3) would allow competitors “to learn from [intervenor’s] mistakes at little or no cost in capital or exposure to risk.”  Id. at *8-10.

In addition, as to FOIA disclosure of the underlying records of detailing sessions (called “verbatims”), the court held:

While the plaintiff is correct that the information in the verbatims is known by both the health care provider who was surveyed and the market research firm, it is not freely or cheaply available from those sources.  A competitor wishing to obtain this information would, absent its release through the FOIA, have to pay a market research firm to conduct a similar survey, incurring the same expenses [intervenor] incurred in the first instance. A competitor’s ability to obtain the information at virtually no cost would cause competitive harm . . ., since it could be used affirmatively by those competitors to challenge [intervenor’s] place in the market and exploit any vulnerability revealed through the verbatims’ content.

Consequently, [intervenor] has shown the underlying records reflecting the content of the detailing sessions . . . are confidential

Id. at *12 (citations and quotation marks omitted).

It is an unfortunate fact of life that, as a result of the government’s monetization of its constitutionally questionable ban on truthful off-label promotion, quite a few of our clients are forced to operate under corporate integrity agreements that require disclosure of promotion-related information to the government.  The Public Citizen litigation is a significant favorable development in determining that plaintiff’s lawyers, either directly or acting through surrogates, cannot obtain our clients’ promotion-related disclosure materials from the government through FOIA requests.