Washington, D.C. —
Last night the United States Senate passed the Food and Drug Administration (FDA) Reauthorization Act conference report which included a provision championed by Senator John Thune and Senator Debbie Stabenow (D-MI) that would reduce the filing of frivolous petitions, which delay entry of generic drugs to the market, and unnecessarily increase drug costs for both taxpayers and consumers.
"This is another step at providing relief for seniors and others who depend on prescription drugs to maintain their health and quality of life. Under current FDA regulations, the simple act of filing a citizen petition, regardless of how meritorious or frivolous that petition may be, automatically delays the approval of a generic drug. Such efforts can postpone the delivery of cheaper generic drugs to the market place. Our provision protects the rights of individuals to file a petition while reducing delays and abuses in the generic drug approval process.
"The rising cost of prescription drugs is one of the largest drivers of health care costs in our country today, which contributes directly to the rising cost of health insurance premiums for families, small businesses and the federal government. I will continue to work to reduce the cost of health care in this country while improving access to care for all South Dakotans," said Thune.
The Thune/Stabenow provision would prohibit delays of generic drug approvals unless the FDA determines that the petition filed raises a genuine, public health concern. It also requires petitioners to disclose any compensation they intend to receive from drug companies or outside groups to file a petition.
"These important changes will help remove the incentive for drug companies to file unfounded or illegitimate citizen petitions which only serve to delay the approval process," said Thune.
The FDA Reauthorization Act will reauthorize the FDA's drug-approval program, which is funded by drug and medical device company use fees. The bill also makes reforms to expand the agency's drug safety authority by requiring drug manufacturers to conduct follow-up safety studies after a drug has been approved.
The U.S. House of Representatives passed the FDA Reauthorization bill by a vote of 405 to 7 on Wednesday, and the Senate passed the bill unanimously last night. The bill will now be presented to the President for his consideration.
"This is another step at providing relief for seniors and others who depend on prescription drugs to maintain their health and quality of life. Under current FDA regulations, the simple act of filing a citizen petition, regardless of how meritorious or frivolous that petition may be, automatically delays the approval of a generic drug. Such efforts can postpone the delivery of cheaper generic drugs to the market place. Our provision protects the rights of individuals to file a petition while reducing delays and abuses in the generic drug approval process.
"The rising cost of prescription drugs is one of the largest drivers of health care costs in our country today, which contributes directly to the rising cost of health insurance premiums for families, small businesses and the federal government. I will continue to work to reduce the cost of health care in this country while improving access to care for all South Dakotans," said Thune.
The Thune/Stabenow provision would prohibit delays of generic drug approvals unless the FDA determines that the petition filed raises a genuine, public health concern. It also requires petitioners to disclose any compensation they intend to receive from drug companies or outside groups to file a petition.
"These important changes will help remove the incentive for drug companies to file unfounded or illegitimate citizen petitions which only serve to delay the approval process," said Thune.
The FDA Reauthorization Act will reauthorize the FDA's drug-approval program, which is funded by drug and medical device company use fees. The bill also makes reforms to expand the agency's drug safety authority by requiring drug manufacturers to conduct follow-up safety studies after a drug has been approved.
The U.S. House of Representatives passed the FDA Reauthorization bill by a vote of 405 to 7 on Wednesday, and the Senate passed the bill unanimously last night. The bill will now be presented to the President for his consideration.