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Request For Clarification Amounts To Discussions

Client Alert | less than 1 min read | 08.04.06

In University of Dayton Research Institute (June 15, 2006, http://www.gao.gov/decisions/bidpro/2969466.pdf), the GAO found that an agency's request for vendors to clarify certain discrepancies in their proposed rate tables constituted discussions because the proposal discrepancies were so material that the agency could not conduct a price evaluation without the clarifications and the corrections resulted in significant changes to the proposed prices. As a consequence, GAO held that the agency was required to conduct meaningful discussions with all offerors in the competitive range, which it had not done with the protester.

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Client Alert | 2 min read | 09.18.25

FDA Announces Intention to Initiate an Aggressive Enforcement Campaign Against Misleading Pharmaceutical Advertising

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (HHS) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising. This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”...