WASHINGTON – U.S. Senator Johnny Isakson, R-Ga., today applauded the passage of legislation that would ensure the Food and Drug Administration (FDA) has the necessary resources to review new medical treatments while making needed changes to the drug approval process to bring lifesaving drugs and products to the market more quickly.

The FDA Reauthorization Act of 2017, H.R.2430, also includes additional measures Isakson worked for that would improve safety and access for patients. These provisions include expanding consumers’ access to over-the-counter hearing aids and modernizing the FDA’s medical device facility inspections.  

“Millions of Americans suffer from medical conditions that do not have adequate treatments, and a strong FDA is essential to getting safe and effective new medicines into the hands of the people who need them,” said Isakson, a member of the Senate Committee on Health, Education, Labor and Pensions. “In addition to funding the FDA’s important work, this legislation will help individuals with mild to moderate hearing loss by improving access to hearing aids, driving down costs and increasing competition.

“Additionally, the current device facility inspection process lacks transparency, predictability and consistency between facilities. Improved communication and consistency in the device facility inspections process will help innovative Georgia companies by allowing both FDA and device manufacturers to make more efficient use of resources.”

The FDA Reauthorization Act of 2017 was previously passed by the Health, Education, Labor and Pensions Committee in May by a bipartisan 21-2 vote.

Background:

Isakson’s Over-the-Counter Hearing Aid Act of 2017 was passed by the Health, Education, Labor and Pensions Committee in May for inclusion in the FDA Reauthorization Act of 2017. He introduced the bipartisan legislation with U.S. Senators Chuck Grassley, R-Iowa, Maggie Hassan, D-N.H., and Elizabeth Warren, D-Mass. This provision would make certain types of hearing aids available over the counter to Americans with mild to moderate hearing impairment. In addition, the legislation would require the FDA to write regulations ensuring that this new category of over-the-counter hearing aids meets the same high standards for safety, consumer labeling and manufacturing protections as all medical devices, providing consumers the option of an FDA-regulated device at lower cost.

Isakson and U.S. Sen. Michael Bennet, D-Colo., introduced bipartisan legislation in February to modernize the FDA’s medical device inspections process. The bill would establish a risk-based inspections process to ensure the frequency and nature of inspections are more consistent around the world. To do this, it would enhance communication between the FDA and companies so they may address quality and compliance issues more efficiently. The bill would also improve the process for granting export certificates to foreign countries for companies that seek to market their devices internationally.

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