Hoeven: Senate Passes FDA Legislation to Improve, Streamline Review for Critical Drugs
Hoeven-Cosponsored “Right to Try” Bill Also Approved By Senate
WASHINGTON – Senator John Hoeven, who serves as chairman of the Senate Agriculture, Rural Development and Food and Drug Administration (FDA) Appropriations Subcommittee, released the following statement after the Senate passed legislation to reauthorize FDA User Fee Agreements and to make reforms that will enable the FDA to streamline its review process for drugs and medical devices.
“This legislation updates and reauthorizes the FDA user fee structure and includes reforms to improve FDA’s drug approval process,” said Hoeven, “That’s important both because it will help to expedite the approval of new drugs, medical devices, and treatments for patients that need them, but also give consumers more health care options and improving patient care.”
Specifically, the legislation:
- Reauthorizes FDA User Fee Agreements. Under these agreements pharmaceutical and medical device companies pay fees to the FDA to help fund the agency’s pre-market review and regulation of prescription drugs, medical devices, generic drugs and biosimilar drugs.
- Makes reforms that will enable the FDA to speed up its review process for drugs that currently lack significant competition.
- Includes reforms to streamline and improve inspections of medical devices.
- Creates a priority review for generic drugs that do not have more than three approved products.
- Requires FDA to maintain a list of drugs with limited competition.
- Provides incentives for companies to enter the market if only one generic drug exists.
- Provides FDA with the authority to require adult cancer drugs that share a common molecular target with a pediatric cancer to be studied in children.
The Senate today also approved the Trickett Wendler Right to Try Act of 2017 (S. 204), legislation cosponsored by Senator Hoeven that provides terminally ill patients with access to experimental treatments when no other treatment options exist.
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