US act aims to end shortages by speeding post-approval changes

In the proposed legislation, called The Drug Shortage Prevention Act​, Democratic Congressman John Carney calls for creation of a national critical drug list. Drugs included on the list would be handled differently in some situations.

“The Secretary shall expedite the review of…any request by the sponsor of a critical drug to approve a change to the manufacturing process, including any change in the facilities used for such process, or an alternate supplier of any active ingredient​”, Carney wrote in the bipartisan legislation.

Speeding review of changes to the manufacturing of critical pharmaceuticals could cut the likelihood of regulatory bottlenecks creating drug shortages. The policy of expediting review of critical drugs would be applied at each step, from marketing authorisation through to post-approval changes.

Expedited review of drugs on the critical list should not cause ‘unnecessary delays’ of other products, the act states, but it is unclear if more resources will be made available to meet this target.

“It is the sense of the Congress that the US Food and Drug Administration should increase the number of personnel responsible for identifying and addressing critical drug shortages​”, Carney wrote. The FDA expects user fees to boost hiring but how many will be involved with drug shortages is unknown.

The critical list​

Defining of the term ‘critical drug’ would occur within 90 days of the act being passed. In considering whether to add a drug to the list the reviewers will consider its medical necessity and vulnerability of its supply, including the number of manufacturers and sources of active ingredients.

Manufacturers could ask for their drug to be removed from the critical list on the grounds that it fails to meet the criteria. An answer will be sent to the manufacturer within 45 days and will include an explanation if the request is rejected.