Today, Senator Richard Burr (R-NC), Ranking Member of the Senate Committee onHealth, Education, Labor and Pensions (HELP), introduced the Food and Drug Administration Simple Reauthorization Act, that would reauthorize the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements to ensure Americans continue to have access to innovative treatments and therapies.
Today’s introduction follows concerns over the Senate’s ability to pass the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act on time and after anti-innovation policies were attached to the bill in Committee, particularly as Democrats put forward a partisan reconciliation package that includes devastating drug pricing proposals.
“For months, the Senate HELP Committee worked diligently to craft a user fee package that not only addresses some of the most difficult issues facing the FDA, but also strengthens agency accountability for commitments made to innovators and patients,” said Senator Burr. “FDA must be forward-looking if we are going to be ready for the next generation of scientific advancements and biomedical technologies to effectively respond to the next public health threat or devastating disease.
“Unfortunately, the user fee package reported out of Committee would, if enacted, undermine the very purpose of the user fee program. The policies added to this bill endanger the development of drugs for rare diseases, imperil intellectual property rights, threaten Americans’ access to breakthrough treatments and cures, and deter private sector innovation. In effect, this proposal would compromise the FDA’s overall ability to keep pace with advancements in the industry it regulates. And Democrats’ recently released drug pricing proposal would further reduce private sector investment, making it more difficult for Americans’ to access new, lifesaving medicines.
“Instead, the legislation I’ve introduced today preserves the user fee agreements as they’ve already been negotiated – without harmful additions. It keeps FDA’s critical operations running, protects existing scientific experts and ongoing hiring activities at the agency, and ensures the agency can continue to review new medical products, while encouraging private sector investment in the next generation of developments. It’s essential that Congress support an agreement that holds the FDA accountable to its performance commitments and brings life-saving, innovative products to Americans for years to come. As the authorizing deadline approaches, this clean reauthorization represents the clearest path forward.”
To read the legislative text of the Food and Drug Administration Simple Reauthorization Act, click here.