Associations to OMB: FDA underestimated admin burden in MOU

Published June 12, 2020

In a joint letter to the Office of Management and Budget organized by APC, four national pharmacy associations say FDA has underestimated the administrative burden that would be incurred by state boards of pharmacy under the recently released ‘final’ MOU on shipments of out-of-state compounded drugs. The letter was signed by NCPA, APhA, NASPA, and APC.

The associations state that the agency didn’t follow the processes laid out clearly in the Paperwork Reduction Act. Rather than survey boards of pharmacy to determine the impact of the MOU, the FDA seems to have relied on old data, anecdotes, or simply guesswork about the amount of time and resources required to meet the MOU’s investigative and reporting requirements.

“The FDA’s analysis […] was inadequate to meet the requirements of the Paperwork Reduction Act,” we wrote, “and should therefore be rejected by OMB and sent back to FDA.”

Also, this week, seven members of Congress sent a letter to OMB making the same point as the association letter. We’re grateful to congressmen Andy Biggs, Buddy Carter (GA), John R. Carter (TX), Doug Collins (GA), H. Morgan Griffith (VA), Gary Palmer (AL), and Chris Stewart (UT) for their support in calling out the shortcomings of the MOU.

“[W]e believe that the analysis submitted by the FDA underestimates the potential cost to state governments, which are finding their resources strained under the current conditions,” they wrote. “This underestimation of burden and cost to the states is perhaps the main reason for FDA overestimating the number of states that will sign the agreement.”

Click here to read our article in the previous Compounding Connections explaining what’s wrong with the MOU.