Bipartisan legislation co-authored by U.S. Reps. Michael Burgess (R-TX) and Greg Walden (R-OR) to reauthorize the U.S. Food and Drug Administration’s user fee program cleared a key subcommittee vote on Thursday.
The House Energy and Commerce Subcommittee on Health’s approval of the FDA Reauthorization Act (FDARA), H.R. 2430, marked “an important milestone” in a two-year effort to reauthorize the user fee program by the biopharmaceutical and medical device industry, the FDA and Congress, said Burgess, the chairman of the subcommittee.
“It is a bipartisan and bicameral priority to complete this work and reauthorize the user fee programs in a timely manner,” Burgess said. “In each of our hearings, we have heard about the tremendous success of the user fee programs in expanding access to affordable medications, supporting biomedical innovation, and maintaining high standards at FDA for safety, efficacy and quality.”
The bill would update and reauthorize the FDA user fee programs for prescription drugs, medical devices, generic drugs and biosimilar biological products.
Walden, the chairman of the House Energy and Commerce Committee, urged Congress to move quickly on approving the critical legislation.
“Let me be clear: if we do not have this bill to the president’s desk in July, not only will thousands of FDA employees be seeking new employment, but desperately needed treatments and cures will not reach patients.”
Legislation authored by U.S. Rep. Leonard Lance (R-NJ) to prevent counterfeit drugs from entering the country, the Drug Diversion and Counterfeit Crackdown Act, was included as an amendment to FDARA.
Counterfeiters, often working in third-world countries, mimic drugs that have been approved by the FDA, but create the knock-off medications using poorly produced ingredients.
“Counterfeit drugs are flooding into the United States and too many Americans are falling victim to knock-offs that have infiltrated the U.S. supply chain,” Lance said.
“These counterfeit drugs contain harmful ingredients and incorrect or expired active ingredients. Cancer patients think they are taking the correct chemotherapy medicine but these fraudsters instead give the unsuspecting patient 50 percent of the real treatment. These criminals take the risk knowing the punishment is a minor offense in our criminal code. That needs to change,” Lance said.
Bills introduced by U.S. Rep. Marsha Blackburn (R-TN) to allow for over-the-counter sales of some hearing aids and by U.S. Rep. Larry Bucshon (R-IN) to amend processes for inspecting device manufacturers were also included in FDARA as amendments.