User Fees

Lawmakers may need to tweak provisions in the recently released over-the-counter monograph reform discussion draft that give FDA authority to issue administrative orders on packaging requirements for OTC drugs and to award two years of exclusivity to OTC drug manufacturers. FDA and stakeholders pointed to both provisions as issues that require a second look from Congress during the House Energy & Commerce health subcommittee’s Wednesday (Sept. 13) hearing on the bill.

House lawmakers released Monday (Sept. 11) a bipartisan discussion draft of their proposed over-the-counter monograph user fee program (OMUFA), coming two days ahead of an Energy & Commerce health subcommittee hearing on ways to reform the OTC monograph process.

President Donald Trump signed Friday (Aug. 18) the FDA Reauthorization Act of 2017, a White House spokesperson tells Inside Health Policy.

FDA will hold a public meeting Sept. 18 to examine the experiences of the agency and stakeholders with structured benefit-risk assessments and approaches to incorporating patient perspectives in these assessments, according to a Tuesday (Aug. 8) agency notice.

Public Citizen is claiming victory after Sens. Orrin Hatch (R-UT) and Bob Menendez (D-NJ)'s Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act, which would extend exclusivity for orphan drugs by six months, was not brought up as part of the FDA user fee package passed by the Senate Thursday (Aug. 3).

A bipartisan Senate bill requiring HHS to develop standards for hospitals and physicians to denote a patient's history of opioid addiction in medical records if a patient provides the information is expected to be passed by unanimous consent Thursday (Aug. 3) morning, a spokesperson for bill sponsor Sen. Joe Manchin (D-WV) tells Inside Health Policy.

Sen. Ron Johnson (R-WI) has agreed to pull back his threat to hold up the FDA user fee package in exchange for a commitment that an amended version of his Right to Try legislation will be taken up by unanimous consent as the Senate moves to pass the user fee package Thursday (Aug. 3), sources tell Inside Health Policy.

Senate Majority Leader Mitch McConnell (R-KY) announced Tuesday (August 1) that Republicans want to vote on the FDA user fee package before the August recess, but one industry source tells Inside Health Policy that while Republicans want to move on the legislation next week, Democratic and Republican leadership have not yet agreed on an amendment package.

Sens. Orrin Hatch (R-UT) and Bob Menendez (D-NJ) are attempting to attach the Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act, which would extend exclusivity for orphan drugs by six months, to the user fee package expected to be taken up by the Senate this week, a Democratic lobbyist tells Inside Health Policy.