User Fees

A bipartisan group of House lawmakers hopes to add to the animal drug user fee package moving through Congress a measure that would expand the scope of FDA's animal drug conditional approval pathway so that it applies to large populations of animals.

Like their colleagues in the Senate did last month, members of the House Energy & Commerce health subcommittee considered Wednesday (March 14) draft language to reauthorize the Animal Drug User Fee Agreement (ADUFA) and the Animal Generic Drug User Fee Agreement (AGDUFA).

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.