June 13, 2017

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House Committee
Approves FDA and
Related Legislation

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House Committee Approves FDA and Related Legislation

The House Energy and Commerce Committee voted unanimously to advance the FDA Reauthorization Act (FDARA) of 2017 on June 7. The bill will reauthorize a package of user-fee agreements (including the Medical Device User Fee Agreement) set to expire in September 2017. This reauthorization will renew each agreement through 2022.

“FDARA would reauthorize the agency’s critically important drug and medical device user fee programs, making improvements to each of them based on lengthy deliberations involving FDA, industry, patient groups, and other stakeholders,” said Chairman Walden. “As I have said before in this room, 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. We cannot – and will not – stand for that.”

Ten amendments were offered to the bill, with only six passing. While Democrats repeatedly upbraided their colleagues for failing to take the opportunity to address high prescription drug costs, one amendment expressed the sense of Congress that “the Secretary of Health and Human Services should commit to engaging with the House ... [to] lower the cost of prescription drugs for consumers.” Other amendments that passed dealt with the cost and safety of medical device servicing as well as modifying requirements for medical imaging devices.

The Senate HELP Committee already completed its mark-up of the user-fee package on May 11. FDA officials have warned both the House and Senate that, if the reauthorization is not complete by the end of July, the agency will have to begin sending notices to staff whose positions are funded through the user-fee programs that their jobs may be discontinued.

The committee also approved H.R. 1492, the Medical Controlled Substances Transportation Act of 2017, authored by Rep. Pete Sessions (R-TX). H.R. 1492 would update the Drug Enforcement Administration registration process for mobile medical practitioners like EMS personnel and team physicians to ensure these health care providers can administer controlled substances at locations other than their principal places of business while complying with new limitations on the timing of transport and related recordkeeping requirements. H.R. 1492 passed unanimously by voice vote.

AAOS is supportive of H.R. 1492, commenting that the Medical Controlled Substances Transportation Act addresses a number of concerns by providing the traveling physician with the guidance and oversight they need to be able to appropriately manage the injury – short of surgery or hospitalization – in a similar fashion to when they are at their home sports facilities. These physicians need to be able to safely and securely prescribe and dispense controlled substances when medically appropriate.

For more information on the markup, including a background memo, archived webcast, and text of the legislation, click here.